More About Dr. Gregory Wiener

CURRENT POSITION: Principal Investigator / Sub Investigator

1997 – Present President GW Research, Inc.

ADDRESS: GW Research, Inc.

353 Church Avenue

Chula Vista, CA 91910

(619) 585-8882/Fax (619) 585-8881

E-MAIL gw@gwresearch.net

DOB March 30, 1954

Endoscopy Centers:

Endoscopy Center of Chula Vista

681 3^rd Avenue

Chula Vista, CA 91910
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Scripps Mercy Hospital

435 H Street

Chula Vista, CA, 91910

BOARD CERTIFIED MEDICAL SPECIALTIES: Gastroenterology, Internal Medicine

EDUCATION AND TRAINING:

7/85 to 6/87 Fellow in Gastroenterolgy

Bowman Gray School of Medicine

Winston-Salem, North Carolina 27103

Chief of Section: Donald O Castell, M.D.

1/85 to 6/85 Chief Resident of Medicine

VA Medical Center

Baylor College of Medicine

Houston, Texas 77030

Chief of Department: Robert Luchi, M.D.

6/1983 to 6/1985 Resident in Internal Medicine

6/1982 to 6/1983 Intern in Medicine

Baylor College of Medicine

Houston, Texas 77030

Chief of Department: Edward Lynch, M.D.

2/80 to 6/1982 Cetec University- M.D. degree

Santo Domingo, Dominican Republic

Senior Clerkships:

1. University of California, San Diego – Pediatrics

2. Baylor College of Medicine – General Medicine, MICU

3. University of California, San Francisco- General Surgery: Infectious Disease

4. Harvard Medical School- Primary Care Surgery: Radiology; Gastroenterology

7/1975 to 10/1980 National University of El Salvador Medical School

San Salvador, El Salvador, Central America

9/1971 to 9/1975 Hobart and William Smith College (B.S., Biology)

Geneva, New York

PROFESSIONAL LICENSURE:

1985 -present California

1985-2002 North Carolina

1986 -1987 Florida

SPECIALTY CERTIFICATIONS:

1985 American Board of Internal Medicine

1987 American Board of Gastroenterology

ACADEMIC APPOINTMENTS:

1982 Chief Medical Resident

Baylor College of Medicine

Houston, Texas 77030

1985 Clinical instructor in Medicine

Baylor College of Medicine

Houston, Texas 77030

1987 to 1988 Clinical Instructor, Gastroenterology

Mercy Hospital and Medical Center

San Diego, CA 92104

1989 to 2005 Voluntary Clinical Instructor, Gastroenterology and Family Medicine

University of California, San Diego (UCSD)

2005 to present Voluntary Clinical Assist. Professor, Gastroenterology

University of California, San Diego (UCSD)

MEMBERSHIPS:

1982 American College of Physicians- Fellowship

1985 American Gastroenterology Association-

1986 American College of Gastroenterology- Fellowship

HONORARY POSITIONS:

2003 Honorary Consul of El Salvador in San Diego, CA

AWARDS:

1990 American College Gastroenterology Rorer Award for

Research Publication

2010 Journal of Voice Best Paper Award in the Clinical Medicine Category

2017 Fellowship of American College of Gastroenterology

STAFF PRIVILEGES:

1987-present Scripps Mercy Hospital, Chula Vista, CA, 91910

1987-present Sharp Chula Vista Medical Center, Chula Vista, CA, 91911

1987-2010 Mercy Hospital and Medical Center, San Diego, CA, 92103

1987-2007 Paradise Valley Hospital 2400 E. Fourth Ave, N.C, CA, 91950

PRESENTATIONS AT MEDICAL MEETINGS:

Amador, A., & Wiener, G.J., “The Thyroid Nodule.” A review of 200 cases seen at the Hospital Rosales for the past six years. XVI Central American Medical congress, El Salvador, 1975.

Amador, A., & Wiener, G.J. “The Management of the Solitary Thyroid Nodule.” Latin American Congress of Nuclear Medicine and Biology, San Jose, Costa Rica, 1976.

Wiener, G.J., & Wu, W.C., Koufman, J.A., Copper, J.B., Richter, J.E., Castell, D.O., Chronic hoarseness with laryngeal pathology as a manifestation of upright gastroesophageal reflux disease (GERD). American College of Gastroenterology, Atlanta, Georgia October 1986 (American Journal of Gastroenterology, 1986; 81, 848A).

Wiener, G.J., & Wu, W.C., Koufman, J.A., Copper, J.B., Richter, J.E., Castell, D.O., Laryngeal pathology may be caused by gastroenterology reflux (GER). An ambulatory pH study. World Congress of Gastroenterology. Rio de Janeiro, Brazil, September 1986 (Digestive Diseases and Science, 1986: 31:10).

Arem, R., Kaplan, M.M., Wiener, G.J. reichlen, S. Tissue thyroxin and triidothyronine concentrations in human nonthyroidal illness. American Thyroid Association Meeting. September 1986.

Wiener G.J., Morgan, T.M., Wu, W.C., Copper, M.B., Castell, D.O., Richter, J.E. Ambulatory 24-hour esophageal pH monitoring: Areproducible test for gastroesophageal reflux (GER). (Gastoenterology, 1987; 92: 1694A) 1987 National AGA Meeting. 1987, Chicago (gastroeneterology 1987; 92:1695A).

Wiener, G.J., Koufman, J.A., Wu, W.C., Richter, J.E., Copper, J.B., Castell, D.O., The pharyngoesophageal dual ambulatory pH probe for evaluation of atypical manifestations of gastroesophageal reflux (GER) Gasronterology, 1987; 92:1694A) 1987 National AGA Meeting.

Wiener, G.J., Copper, J.B., Wu, W.C., Richter, J.E., Castell, D.O. The symptom index (SI); an endogenous 24-hour provocative test for symptoms of gastroesophageal reflux (GER). Gastroenterology, 1987; 92:1694A). 1987 National AGA Meeting.

Wiener, G.J., Is manometric definition of the LES position mandatory for accurate positioning of the pH electrode? Fifth World Congress of the International Organization of Statistics studies on Disease of the Esophagus. Paris September 1996.

Wiener, G.J.,Dx-pH Measurement System: A Sensitive Device for
Detecting Liquid and Aerosolized Supraesophageal Gastric Reflux (SEGR). DDW oral presentation, Los Angeles, CA 2006

Wiener GJ, Tsukashima R, Kelly C, Wolf EH, Schmeltzer ME, Bankert CS, Fisk L: Dx–pH measurement System: A Sensitive Device for Detecting Liquid and Aerosolized Supraesophageal gastric Reflux (SEGR). Gastroenterology 130(4) Suppl S2:A-115,2006.

B. Misra, J. Curran, H. Herfarth, K. Jagarlamudi, C. Oneto, B.R. Bhandari, G. Wiener, D. Kerman, A. Moss, R. Pomerantz, J. Zhao, P. Bernardo, S. Simmons, L. Diao, E. O’Brien, M. Henn, and M. Trucksis* SER-287, Presentation during Digestive Disease Week® (DDW) 2018 at Walter E. Washington Convention Center, Washington, DC, June 2-5, 2018.

Thomas L. Abell, MD, Lazaro M. Garcia, MD, Gregory Wiener, MD, John M.Wo, MD, Robert S. Bulat, MSc MD PHD FRCPC, Neil Smith, PharmD, Improved Gastric Accommodation in Women with Moderate or Severe Diabetic Gastroparesis Randomized to Oral CNSA-001 (Sepiapterin) versus Placebo Poster 20-1162 GAS-001_DDW_v2 Presentation at DDW2020

PUBLICATIONS:

Wiener, G.J., Copper, J.B, Koufamn, J.A., Richter, J.E., Castell D.O., Is hoarseness an atypical manifestation of gastresophageal reflux? An ambulatory 24- hour pH study. Gastroenterology. 1986; 80 A169.

Wiener, G.J., & Castell, D.O. Evaluation of the patient with noncardiac chest pain. Diagnosis, 1986; 8:10, cover article.

Wiener, GJ., Koufman, JA., Wu W.C., et al. The pharyngo-esophageal dual ambulatory pH probe for evaluation of gastroesophageal reflux (GER). Gastroenterology; 1987; 92:1694 (abstract).

Peters, L., Wiener, G.J., et al. Adult Reye’s syndrome: a case report, review of the literature. Archives of Internal Medicine, 1986; 146:2401-2403.

Reid, C.L. Wiener, G.J., Richter, J.E., Cox, D., Geisingr, K. Diffuse hepatocellular dysplasia and carcinoma associated with M-Malton variant of alpha-1-antitrypsin. Gastroenterolgy; 1987; 94:1-7.

Koufman, J.A., Wiener, G.J., Reflux laryngitis and its sequelae: the diagnosis role of ambulatory 24-hour pH monitoring. Journal of Voice, 1988; 1:78-79.

Wiener, G.J., Richter, J.E., Copper, P.A., Wu W.C., Castell, D.O. The Symptom Index: A clinically important parameter of ambulatory 24-hour esophageal pH monitoring. The American Journal of Gastroenterolgy, 1988; 83:353-361.

Wiener, G.J., Morgan, T.M., Copper, J.B., et al. Ambulatory 24-hour esophageal pH monitoring: Reproducibility and Variability of pH parameters. Dig. Dis. Sci., 1988.

Wiener, G.J., Koufman, J.A., Copper, J.B., Richter, J.E., Castell, D.O. Chronic hoarseness secondary to gastroesophageal and pharyngeal pH probes. American Journal of Gastroentrolgy, 1989; 84:1503-1508.

Arem, R., Wiener, G.J., Kaplan, S.G., et al. Reduced Tissue Thyroid Hormone Levels in Fatal Illness. Metabolism, 1993; Vol 42, No 9: 1102-1108

Wiener, G.J. Is Manometric definition of the LES position mandatory for accurate positioning of the pH electrode? O.E.S.O: The Esophagogatric Junction Guli, R., Galmiche, G.C., Jamieson, C.et.al. John Libbey Eurotext, Montrogue, France:1998.

Wiener, G.J. Re: Fouad et.al. - GERD. American Journal of Gastroenterology, 1999:9; 4:3658

Wiener, G.J., Complications caused by the tip of Gastrenterolgy tubes and foley Catheters. American Journal of Gastroenterology, 1999; 94:3656

Wiener GJ, Bankert CS, Kelly C, Fisk L, Schmeltzer ME, Wolf EH, Tsukashima R: Dx–1 A New Device for Detecting Supraesophageal Gastric Reflux (SEGR). Am J Gastroenterol (100)(9): 2005; S26 (poster).

Wiener, GJ, et al. Dx-pH Measurement System: A Sensitive Device for Detecting Liquid and Aerosolized Supraesophageal Gastric Reflux (SEGR) [abstract] Gastroenterology. 2006; 130:4 (suppl 2): A115.

Wiener, Gregory. Detecting Supraesophageal Reflux.Advances for Managers of Respiratory Care. 2006; 15-3:47.

Wiener, Gregory et al. Oropharyngeal pH Monitoring for the Detection of Liquid and Aerosolized Supraesophageal Gastric Reflux. Journal of Voice, 2009, Vol 23, No. 4, pp 498-504

Wiener G.J., Graham DY, Canaan Y, Maher J, Hulten KG, Kalfus IN. Rifabutin-Based Triple Therapy (RHB-105) for Helicobacter pylori Eradication: A Double-Blind, Randomized, Controlled Trial. Ann Intern Med. 2020 Jun 16;172(12):795-802. doi: 10.7326/M19-3734. Epub 2020 May 5. PMID: 32365359.

Wiener G.J., Miner Jr P.B., Koltun W.D., et al. A randomized phase III clinical trial of plecanatide, a uroguanylin analog, in patients with chronic idiopathic constipation. Am J Gastroenterol; doi:10.1038/ajg.2016.611.

Wiener G.J., Abell TL, Garcia LM, Wo JM, Bulat RS, Smith N. Effect of Oral CNSA-001 (sepiapterin, PTC923) on gastric accommodation in women with diabetic gastroparesis: A randomized, placebo-controlled, Phase 2 trial. J Diabetes Complications. 2021 Sep;35(9):107961. doi: 10.1016/j.jdiacomp.2021.107961. Epub 2021 Jun 17. PMID: 34176722.

Di Palma J.A., Wiener G.J.,Winkle P., McGowan, J.D., Cleveland M.B., A phase 2 evaluation of a new flavored peg and sulfate solution compared to an over the-counter laxative, Peg and sport s drink bowel preparation combination. Accepted for Publication 2023
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Imperiale TF, Porter K, Zella J, Gagrat ZD, Olson MC, Statz S, Garces J, Lavin PT, Aguilar H, Brinberg D, Berkelhammer C, Kisiel JB, Limburg PJ; BLUE-C Study Investigators. Next-Generation Multitarget Stool DNA Test for Colorectal Cancer Screening. N Engl J Med. 2024 Mar 14;390(11):984-993. doi: 10.1056/NEJMoa2310336. PMID: 38477986.

CLINICAL RESEARCH

CERTIFICATIONS:

1. Investigator Training for Medical Research: University of Rochester School of Medicine and

Dentistry and Western Institutional Review Board (WIRB), May 4, 2001.

2. Shipping Infectious Substances (IATA and DOT) Online Training. Eduwhere July 2009 and July

2011. Inc Research 19Sep2016

3. CITI CERTIFICATION Basic Course in the Protection of Human Subjects and Good Clinical Practices/ University of Miami (Scripps Hospital Affiliation Program.) October 2012

4. NIDA Clinical Trials Network: GCP Training Certificate 15July2016

5. INC Research: GCP Training, Revision 2 Changes, and Refresher Course Certificate 28Oct2017

CLINICAL TRIALS-INVESTIGATOR:

1. Principal Investigator: A Randomized Study of Oral Lobucavir vs. Alpha Interferon in Subjects Chronically Infected with Hepatitis B Virus. June 1998- April 1999. (1 patient enrolled, Sponsor cancelled study).

2. Principal Investigator: A Multicenter, Randomized, Double-Blind, Safety and Efficacy Study of H 199/18 for the Eradication of Helicobacter pylori in Subjects with Active Duodenal Ulcer or History of Duodenal Ulcer Disease. October 1998- April-1999. (3 patients screened and randomized)

3. Principal Investigator: A twelve week randomized, double-blinded, placebo-controlled study of the efficacy and tolerability of Aloseteron Hydrochloride 1mg twice daily for control of bowel urgency in patients with diarrhea-predominant irritable bowel syndrome. 1999-2000. (8 screened, 2 randomized)

4. Principal Investigator: Aciphex Post Marketing Fast Trial 2000 (10 patients screened and randomized)

5. Principal Investigator: A Comparative Efficacy Study of esomeprazole Magnesium 40mg and Lansoprazole 30mg in patients with erosive esophagitis. September 2000- December 2000. (32 patients randomized, 5 screen failures).

6. Principal Investigator: A Double-Blinded, Placebo-Controlled, Randomized, Multicenter Study to Investigate the Safety and Efficacy of 2 mg TID of Cilansetron Over 12 Weeks Followed by a 4-week rerandomized treatment of period in diarrhea-predominant Irritable Bowel Syndrome Subjects. (12 Screened, 8 Randomized)

7. Principal Investigator: A Randomized Double-Blind Trail Comparing the Early Profile of Heartburn Relief Associated with Rabeprazole, 20 mg Once Daily vs. Omeprazole, 20mg Once Daily in Gastroesophageal Reflux Disease Patients with an Acute or Documented History of Erosive Esophagitis. (23 Screened, 19 Randomized)

8. Principal Investigator: A randomized, double-blind, placebo-controlled, parallel group, mulitcenter study to assess the efficacy and safety of repeated treatment with tegaserod 6 mg b.i.d. and placebo in female patients with irritable bowel syndrome with constipation (IBS-C) (23 Screened,20 Randomized)

9. Principal Investigator: A Twelve-Week Randomized, Double Blind, Placebo-Controlled, Parallel-Group Study to Assess the Safety and Efficacy of 0.5mg QD, 1mg QD and 1mg BID of Alosetron in Female Subject with Severe Diarrhea-predominant IBS Who Have Failed Conventional Therapy

10. Principal Investigator: Dx-1 Non-Invasive pH Measurement Device Study. September 2004-October 2005

11. Principal Investigator: A 12-Week Multi-center, Double Blind, Randomized Efficacy and Safety Study of Lubiprostone for the treatment of Constipation Predominant Irritable Bowel Syndrome (PRA International Trial)

12. Principal Investigator: A Phase 3 Study to Evaluate the Efficacy and Safety of: TAK-390MR – Studies T-EE04-084, TGD-04082, T-EE04-086, T-GI04-088, TGI05-137, TEE05-135 (6 Studies) November 2005-2006 (48 patients enrolled, 25 screen failures)

13. Principal Investigator: A Phase III, Multicenter, Randomized, Double Blind, Placebo-Controlled, Parallel Group Study of Renzapride in Women with Constipation Predominant Irritable Bowel Syndrome. June 2007

14. Principal Investigator: Gastrointestinal (GI) Randomized event and safety Open-Label NSAID Study (GI-REASONS): A Randomized Open Label, Blinded Endpoint, Parallel-Group Trial of GI Safety of Celecoxib Compared with Non-Selective Nonsteroidal Anti-inflammatory 22 Drugs (NSAIDS) in Osteoarthritis Patience. January 2007-2008.

15. Principal Investigator: Multicenter, randomized, placebo controlled, Double Blinded Study of the Efficacy and Safety of Lubiprostone in patients with Opioid –induced Bowel Dysfunction. 2008.

16. Principal Investigator: A Multicenter, randomized, placebo-controlled, double blinded study on the efficacy and safety of SPI-8811 for the prevention of nonsteroidal anti-inflammatory drug – induced gastroduodenal injury in patients with osteoarthritis and / or rheumatoid arthritis. February-December 2008.

17. Principal Investigator: A Randomized Double-Blind parallel study of Rabeprazole Extended release 50mg versus Esomeprazole 40 mg for healing and symptomatic relief of mild to moderate erosive gastroesophageal reflux disease (GERD). July 2008 – June 2009 (30 screened, 9 randomized)

18. Principal Investigator: A Randomized Double-Blindparallel study of Rabeprazole Extended release 50mg versus Esomeprazole 40 mg for healing and symptomatic relief of moderate to severe erosive gastroesophageal reflux disease (GERD). March 2008 – June 2009 (20 screened, 10 randomized)

19. Principal Investigator: A Randomized Double-Blind parallel study and of Rabeprazole Extended release 50mg versus Esomeprazole 40 mg for maintenance of erosive gastroesophageal reflux disease (GERD). March 2008 -June 2009 (7 screened,7 randomized)

20. Principal Investigator: A Phase 3, Randomized, double blind, placebo-controlled, multicenter study to assess the efficacy and safety of rifaximin 550 mg TID in the treatment of subjects with non – constipation irritable bowel syndrome. Nov 2008 -Apr 2009 (5 screened,4randomized)

21. Principal Investigator: A phase 3, randomized double-blind, placebo-controlled, parallel-group trial of linaclotide administered orally for 12 weeks followed by a 4-week randomized withdrawal period in patients with chronic constipation. January 2009 (8 screened,1 Randomized)

22. Principal Investigator: An Open-label, Long-term Safety Study of Oral Linaclotide Administered to patients with Chronic Constipation or Irritable Bowel Syndrome with Constipation. January 2009 – September 2011 (6 screened, 4 randomized)

23. Principal Investigator: A Phase III, Randomized, Double-Blind, Dose-Response, Stratified, Placebo-Controlled Study Evaluating the Safety and Efficacy of SPD476 versus Placebo over 104 weeks in the Prevention of Recurrence of Diverticulitis 2009-2012 (11 screened,8 randomized)

24. Principal Investigator: A phase 3, randomized double-blind, placebo-controlled, parallel-group trial of linaclotide administered orally for 26 weeks with Irritable Bowel Syndrome with constipation. September 2009 (17 screened,1 randomized)

25. Principal Investigator: A 12-Week, Randomized, Double-Blind, Placebo-Controlled Study of Asimadoline in Subjects with Diarrhea-Predominant Irritable Bowel Syndrome (D-IBS). September 2010 – March 2013 (39 screened,9 randomized)

26. Principal Investigator: A 6-Month, Phase 3, Randomized, Double-Blind, Parallel-Group, Controlled, Multi-Center Study to Evaluate the Incidence of Gastric Ulcers Following Administration of Either PA32540 or Enteric Coated Aspirin 325 mg in Subjects Who Are at Risk for Developing Aspirin-Associated Ulcers April 2010 – March 2012 (17 screened,9 randomized)

27. Principal Investigator: A Phase 3, Randomized, double blind placebo controlled multicenter study to assess the efficacy and safety of budesonide foam ( 2mg/25ml bid for 2 weeks, followed by 2mg/25 ml qd for 4 weeks) versus placebo in subjects with active mild to moderate ulcerative proctitis or proctosigmoidits: August 2010- June 2013(9 screened, 3Randomized)

28. Principal Investigator: A Phase 3, Open Label, Multicenter Study to Assess the Safety and Tolerability of Budesonide Foam in Subjects with Active Ulcerative Proctitis or Proctosigmoiditis: September 2011 – September 2013 (1 randomized)

29. Principal Investigator: A Phase 2b Randomized, Double-Blind, Placebo-Controlled, 28-Day Repeat, Oral, Dose-Ranging Study to Assess the Safety and Pharmacodynamic Effects of SP-304 in Patients with Chronic Idiopathic Constipation: October 2011 –February 2013 (40 screened, 20 randomized)

30. Principal Investigator: JNJ, A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy, Safety and Tolerability of JNJ-27018966 in the Treatment of Patients with Diarrhea-Predominant Irritable Bowel Syndrome: May 2012 – February 2014 (14 screened, 7 randomized)

31. Principal Investigator: JNJ, A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy, Safety and Tolerability of JNJ-27018966 in the Treatment of Patients with Diarrhea-Predominant Irritable Bowel Syndrome – Open Label: June 2013 – February 2014 (3 screened, 2 randomized)

32. Principal Investigator: Salix Pharmaceuticals, A Study to Assess Repeat Treatment Efficacy and Safety of Rifaximin 550 mg TID in Subjects with Irritable Bowel Syndrome with Diarrhea (IBS-D): June 2012 – June 2014 (34 screened, 17 enrolled)

33. Principal Investigator: Synergy Pharmaceuticals, A Randomized, 12-Week, Double-Blind,

Placebo-Controlled, Dose-Ranging Study to Assess the Safety and Efficacy of Plecanatide in Patients with Irritable Bowel Syndrome with Constipation (IBS-C): November 2012-September 2013 (23 screened, 13 randomized)

34. Principal Investigator: Hutchinson Pharmaceuticals, A Phase 3, Double-Blind, Multi-Center, Placebo-Controlled Maintenance Trial Designed to Evaluate the Efficacy and Safety of HMPL-004 in Subjects with Mild to Moderate Ulcerative Colitis with Clinical Remission or Response from Induction Therapy: March 2013-November 2014 (8 screened, 4 randomized)

35. Principal Investigator: Cubist Pharmaceuticals, A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Long-Term Safety and Tolerability of CB-5945 for the Treatment of Opioid-Induced Constipation in Adults taking Opioid Therapy for Chronic Non-Cancer Pain: May 2013 – September 2013 (3 screened, 2 randomized)

36. Principal Investigator: Ferring Pharmaceuticals, A Double-Blind, Randomized, Placebo-Controlled, Phase 3 Trial in Patients with Chronic Idiopathic Constipation to Demonstrate the Efficacy and Safety of Elobixibat 5mg and 10mg for 26 weeks: July 2013 – June 2014 (15 screened, 3 randomized) Study Closed by Sponsor

37. Principal Investigator: Ferring Pharmaceuticals, A Multi-Center, Open-Label, Safety and Tolerability Extension Trial of 5mg and 10mg Elobixibat Daily in the Treatment of Chronic Idiopathic Constipation: March 2014 – March 2014 (3 randomized) Study Closed by Sponsor

38. Principal Investigator: Synergy Pharmaceuticals, A Randomized, 12-Week, Double-Blind, Placebo-Controlled, Repeat-Dose. Oral, Dose-Ranging Study to Assess the Safety and Efficacy of Plecanatide in Patients with Irritable Bowel Syndrome with Constipation (IBS-C). December 2012 – May 2014 (39 screened, 10 randomized)

39. Principal Investigator: Salix Pharmaceuticals, A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Multicenter Study to Assess the Efficacy and Safety of Rifaximin Soluble Solid Dispersion (SSD) Tablets for the Prevention of Complications in Subjects with Early Decompensated Liver Cirrhosis: September 2013 – September 2015 (20 screened, 13 randomized)

40. Principal Investigator: Synergy Pharmaceuticals, A Randomized, 12 Week, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of Plecanatide (3.0 and 6.0) in Patients with Chronic Idiopathic Constipation (CIC3). November 2013 – April 2015 (55 screened, 26 randomized) Top Enroller.

41. Principal Investigator: Synergy Pharmaceuticals, An Open-Label Extension (OLE), Long-term Safety and Tolerability Study of Plecanatide in Patients with Chronic Idiopathic Constipation (CIC). September 2013 – April 2016 (101 screened, 101 randomized) Top Enroller.

42. Principal Investigator: Menarini Ricerche, A 12-week double-blind, randomized, placebo-controlled, parallel-group phase III study, followed by a 4-week randomized withdrawal period to evaluate the efficacy and safety of oral ibodutant 10 mg once daily in female patients with irritable bowel syndrome with diarrhea (IBS-D). Study Code: NAK-06; Study Acronym: IRIS-3: Ibodutant for Relief of Irritable Bowel Syndrome: March 2014 – September 2015 (10 screened, 4 randomized)

43. Principal Investigator: Theravance Pharmaceuticals, Multicenter, Double-Blind, Randomized, Placebo- Controlled, Parallel-Group Phase 2 Study to Assess the Efficacy, Safety, and Tolerability of Velusetrag for the Treatment of Diabetic or Idiopathic Gastroparesis. August 2014-October 2014 (12 screened)

44. Principal Investigator: Ironwood Pharmaceuticals, ICP-112-202; A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Phase 2a Study of Oral IW-9179 Administered Once and Twice Daily for 4 Weeks to Patients with Diabetic Gastroparesis. November 2014 - 2016 (63 screened, 12 randomized) Top Enroller.

45. Principal Investigator: Ironwood Pharmaceuticals, A Phase 3, International, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Trial of Linaclotide Administered Orally for 12 Weeks to Patients with Irritable Bowel Syndrome with Constipation (IBS-C). December 2014 – July 2015 (9 screened, 4 randomized) NCT01880424

46. Principal Investigator: Sucampo Pharmaceuticals, A Randomized, Double-blind, Placebo-Controlled, Multicenter Study of the Efficacy and Safety of Lubiprostone in Adult Subjects With Mixed or Unsubtyped Irritable Bowel Syndrome (IBS-M/IBS-U) February 2015 – December 2016 (13 screened, 7 randomized)

47. Principal Investigator: Ironwood Pharmaceuticals, A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial of Linaclotide (72 ug or 145 ug) Administered Orally for 12 Weeks to PatientsWith Chronic Idiopathic Constipation February 2015- October – 2015 (32 screened, 8 randomized) (CIC) NCT02291679

48. Principal Investigator: Shire Pharmaceuticals, Oral Budesonide Suspension (OBS) in Adolescent and Adult Subjects (11 to 55 Years of Age, Inclusive) With Eosinophilic Esophagitis: A Phase 3 Randomized, Double-blind, Placebo-controlled Study November 2015 – March 2020 (8 screened, 2 randomized) NCT02605837

49. Principal Investigator: Ardelyx Pharmaceuticals, A 12-Week, Randomized, Double-Blind, Placebo-Controlled Study With a 4-Week Randomized Withdrawal Period to Evaluate the Efficacy and Safety of Tenapanor for the Treatment of Constipation-Predominant Irritable Bowel Syndrome (IBS-C) October 2015 – October 2016 (14 screened, 4 randomized) NCT02621892.

50. Principal Investigator: Ardelyx Pharmaceuticals, A 26-Week, Randomized, Double-Blind, Placebo-Controlled Study With a 4-Week Randomized Withdrawal Period to Evaluate the Efficacy and Safety of Tenapanor for the Treatment of Constipation-Predominant Irritable Bowel Syndrome (IBS-C) February 2016 – September 2017 (17 screened, 10 randomized)

51. Principal Investigator: Ironwood Pharmaceuticals, A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Range-Finding Trial of IW-3718 Administered Orally for 8 Weeks to Patients with Symptomatic GERD that Persists Despite Treatment with Proton Pump Inhibitors. March 2016 – June 2017 (28 screened, 7 randomized) NCT02637557

52. Principal Investigator: Synergy Pharmaceuticals Inc, A Randomized, 12-Week, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of Plecanatide (3.0 and 6.0 mg) in Patients with Chronic Idiopathic Constipation. August 2016 – April 2017. (10 screened, 8 randomized)

53. Principal Investigator: SERES Therapeutics, Phase 1b Multicenter, Randomized, Double-Blind, Placebo-Controlled Multiple Dose Study Designed to Evaluate the Safety and Tolerability of SER-287, and to Evaluate the Microbiome Alterations and Pharmacodynamics Associated with 2 Dosing Regimens of SER-287 in Adults Subjects with Mild-to-Moderate Ulcerative Colitis. September 2016 – 2017. (4 screened, 3 randomized) NCT02618187

54. Principal Investigator: Theravance Pharmaceuticals, Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Phase 2 Study to Assess the Efficacy, Safety and Tolerability of Velusetrag for the Treatment of Diabetic and Idiopathic Gastroparesis. September 2016 – January 2017. (24 screened, 11 randomized) NCT02267525

55. Principal Investigator: Sucampo Pharmaceauticals, A Randomized, Placebo-controlled, Double-blinded, Multicenter Study of the Bioequivalence of Sprinkle and Capsule Formulations of Lubiprostone, as Compared to Placebo, in Adult Subjects with Chronic Idiopathic Constipation May 2017 – June 2017 (13 screened, 6 randomized)

56. Principal Investigator: Genfit Pharmaceuticals, Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Study to Evaluate the Efficacy and Safety of Elafibranor in Patients with Nonalcoholic Steatohepatitis (NASH) and fibrosis. November 2016– 2018 (20 screened, 8 randomized) NCT02704403

57. Principal Investigator: Octeta Therapeutics, Phase 2, Randomized, Double-Blind, Placebo-Controlled, 12-Month, Multiple-Dose Study to Evaluate the Safety, Tolerability and Efficacy of Three Dose Levels of MSDC-0602K in Patients with NASH. December 2016 – 2017. (11 screened, 6 randomized) NCT02784444

58. Principal Investigator: Intercept Pharmaceuticals, Phase 3, Double-Blind, Randomized, Long-Term, Placebo-Controlled, Multicenter Study Evaluating the Safety and Efficacy of Obeticholic Acid in Subjects with Nonalcoholic Steatohepatis. (Patient enrollment time - 10 years) December 2016–ongoing (30 screened, 6 Randomized) NCT02548351

59. Principal Investigator: Allergan Pharmaceuticals, Phase 4 Multicenter, Multinational, Prospective, Randomized, Placebo-Controlled, Double-Blinded Parallel Group Study to Assess Efficacy of Eluxadoline in the Treatment of Irritable Bowel Syndrome with Diarrhea (IBS-D) in Patients Who Report Inadequate Control of IBS-D Symptoms with Prior Loperamide Use. January 2017 – October 2017. (12 screened, 5 Randomized)

60. Principal Investigator: Ferring Pharmaceuticals, Phase 3, Randomized, Assessor-Blinded, Multi-Center Study Investigating the Efficacy, Safety, and Tolerability of Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid Oral Solution versus Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid Powder for Oral Solution (PREPOPIK) for Colon Cleansing in Preparation for Colonoscopy. February 2017 – January 2018 (101 Screened, 90 Randomized) Top Enroller.

61. Principal Investigator: A Randomized Double Blind Active Comparator Controlled Phase III Study to Assess the Safety and Efficacy of RHB-105 in the Treatment of Confirmed Helicobacter pylori (H. pylori) Infection, RHB-105-02 July 2017 – December 2018 (49 Screened, 20 Randomized) Top Enroller.

62. Principal Investigator: A Safety and Efficacy Comparison of BLI4700 Bowel Preparation

versus an FDA-approved Comparator in Adult Subjects prior to Colonoscopy January 2018 – November 2018 (12 Screened, 12 Randomized) Top Enroller.

63. Principal Investigator: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy of Tradipitant in Relieving Symptoms of Gastroparesis February 2018 (6 Screened)

64. Principal Investigator: RLM-MD-02: A 12-week, Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Safety and Efficacy of Relamorelin in Patients with Diabetic Gastroparesis March 2018 (23 Screened)

65. Principal Investigator: RLM-MD-03: A 46-week, Double-blind, Placebo-controlled, Phase 3 Study with a 6-week Randomized-withdrawal Period to Evaluate the Safety and Efficacy of Relamorelin in Patients with Diabetic Gastroparesis July 2018 (3 randomized rollovers)

66. Principal Investigator: RLM-MD-04: A 52-week, Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Safety and Efficacy of Relamorelin in Patients with Diabetic Gastroparesis June 2018 (10 screened)

67. Principal Investigator: MCP-103-312: A Phase 3b, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial of Linaclotide 290 µg Administered Orally for 12 Weeks in Patients with Irritable Bowel Syndrome with Constipation July 2018 (30 screened, 16 randomized)

68. Principal Investigator: C3718-301: A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Trial of Oral IW-3718 Administered to Patients with Gastroesophageal Reflux Disease while receiving Proton Pump Inhibitors September 2018 (43 screened, 10 randomized)

69. Principal Investigator: Protocol G28-006: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Durability, Safety, and Tolerability of RP-G28 in Patients with Lactose Intolerance August 2018 (22 screened, 13 randomized)

70. Principal Investigator: 3152-301-002 - AURORA: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Cenicriviroc for the Treatment of Liver Fibrosis in Adult Subjects with Nonalcoholic November 2018 – 2020 (20 screened, 9 randomized)

71. Principal Investigator: VP-VLY-686-3301Vanda: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Study to Assess the Efficacy of Tradipitant in Relieving Symptoms of Gastroparesis (Patient enrollment time - 16 weeks) November 2019 – ongoing (85 screened, 21 randomized)

72. Principal Investigator: Phathom EE-301: A Phase 3, Randomized, Double-Blind, Two-Phase, Multicenter Study to Evaluate the Efficacy and Safety of Vonoprazan 20 mg Compared to Lansoprazole 30 mg for Healing in Patients with Erosive Esophagitis and to Evaluate the Efficacy and Safety of Vonoprazan (10 mg and 20 mg) Compared to Lansoprazole 15 mg for the Maintenance of Healing in Patients with Healed Erosive Esophagitis November 2019 – October 2021 (58 screened, 24 randomized)

73. Principal Investigator: 2018-10, An Evaluation of a Multi-target Stool DNA (mt-sDNA) Test, Cologuard, for CRC Screening in Individuals Aged 45-49 and at Average Risk for Development of Colorectal Cancer: Act Now October 2019 – (47 screened)

74. Principal Investigator: PBGD 1001, An Open Label, Multicenter Study to Assess the Efficacy and Safety of Salix Probiotic Blend in Patients with Functional Gastrointestinal Disturbances October 2019- December 2019 (20 screened, 20 randomized)

75. Principal Investigator: Genentech, Inc. GC41033A Phase II, randomized, parallel-group, double-blind, placebo-controlled, multicenter study to evaluate the efficacy, safety, and pharmacokinetics of bfkb8488a compared with placebo in patients with non-alcoholic steatohepatitis, February 2019- 2021 (Screened 10)

76. Principal Investigator: APD371-‑202, A Phase 2, Multi‑Center, Randomized, Double‑Blind, Placebo‑Controlled Parallel‑Group Study to Evaluate the Safety, Tolerability, and Efficacy of Olorinab in Subjects with Irritable Bowel Syndrome Experiencing Abdominal Pain. February 2019-July 2021 (8 screened, 1 randomized)

77. Principal Investigator: Braintree Protocol BLI4900-302, A Safety and Efficacy Comparison of BLI4900 Bowel Preparation versus an FDA-approved Comparator in Adult Subjects prior to Colonoscopy, February 2019- 2020 (31 screened, 31 randomized)

78. Principal Investigator: Urovant URO-901-2001: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Vibegron Administered Orally for 12 Weeks to Women with Irritable Bowel Syndrome (12 screened, 6 randomized)

79. Principal Investigator: Allakos Study AK002-019: A Prospective Study to Identify the Incidence of Eosinophilic Gastrointestinal Diseases and Elevated Tissue Mast Cells among Patients with Chronic Gastrointestinal Symptoms. March 2020- December 2020 (24 screened, 23 randomized)

80. Principal Investigator: TAK-906-2002: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2b Study to Evaluate the Efficacy and Safety of Twice-Daily Oral Administration of a Peripherally Acting Dopamine Receptor D2/D3 Antagonist, TAK-906 for the Treatment of Adult Subjects With Symptomatic Idiopathic or Diabetic Gastroparesis. December 2018 -July 2021 (35 screened, 11 randomized)

81. Principal Investigator: Exact Sciences Act Fast 2018-07: Blood and Stool Sample Collection in Subjects with a Diagnosis of Colorectal Cancer or Colorectal Lesion. April 2019-ongoing (21 screened/enrolled)

82. Principal Investigator: Phathom HP-301: A Phase 3 Randomized Multicenter Study to Evaluate the Efficacy and Safety of Open-Label Dual Therapy with Oral Vonoprazan 20 mg or Double-Blind Triple Therapy with Oral Vonoprazan 20 mg Compared to Double-Blind Triple Therapy with Oral Lansoprazole 30 mg Daily in Patients with Helicobacter Pylori Infection. October 2019- May 2021 (37 screened, 26 randomized)

83. Principal Investigator: Allakos Study AK002-016: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of AK002 in Patients with Moderately to Severely Active Eosinophilic Gastritis and/or Eosinophilic Duodenitis (formerly referred to as Eosinophilic Gastroenteritis) Who Have an Inadequate Response with, Lost response to, or Were Intolerant to Standard Therapies, December 2020- August 2023 (31 Screened, 8 Randomized)

84. Principal Investigator: Exact Sciences, 2019-01: “Clinical Validation of an Optimized Multi-Target Stool DNA (mt-sDNA 2.0) TEST, for Colorectal Cancer Screening” February 2021- May 2023 (297 screened/randomized)

85. Principal Investigator: Neurogastrx NG101-201: A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Safety and Efficacy of NG101 Administered Orally to Patients with Gastroparesis. May 2021- April 20232 (27 screened, 3 randomized)

86. Principal Investigator: Phathom NERD-201: A Phase 2, Randomized, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of Vonoprazan 10 mg, 20 mg and 40 mg Compared to Placebo for Relief of Episodic Heartburn in Subjects with Symptomatic Non-Erosive Gastroesophageal Reflux Disease. March 2021- February 2022 (33 screened, 8 randomized)

87. Principal Investigator: Allakos Study AK002-016X: A Phase 3, Multicenter, Open-Label, Extension Study to Evaluate the Efficacy and Safety of AK002 in Patients That were Previously Enrolled in AK002-016 or AK002-012 studies and have Eosinophilic Gastritis and/or Eosinophilic Duodenitis (formerly referred to as Eosinophilic Gastroenteritis). July 2021- September 2023 (8 screened, 7 randomized)

88. Principal Investigator: Allakos Study AK002-021: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of AK002 in Patients with Moderately to Severely Active Eosinophilic Duodenitis who have an Inadequate Response with Lost Response to, or were Intolerant to Standard Therapies. July 2021- March 2023 (17 screened, 3 randomized)

89. Principal Investigator: Ionis ION224-CS2: An Adaptive Two-Part Phase 2, Multi-Center, Randomized, Double Blind, Placebo-Controlled Study to Assess the Safety, Efficacy, and Pharmacokinetics of Multiple Doses of ION224 Administered Once Monthly in Adult Subjects with Confirmed Non-Alcoholic Steatohepatitis. (Patient enrollment - 1.5 years) July 2022-ongoing (15 screened, 2 randomized)

90. Principal Investigator: Phathom NERD-301: A Phase 3, Randomized, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of Vonoprazan 10 and 20 mg Compared to Placebo for Relief of Heartburn in Subjects with Symptomatic Non-Erosive Gastroesophageal Reflux Disease (NERD) After 4 Weeks and to Evaluate the Efficacy and Safety of Vonoprazan 10 and 20 mg for Relief of Heartburn in Subjects with NERD After 6 Months. February 2022-July 2023 (55 screened, 15 randomized)

91. Principal Investigator: Exact Sciences 2021-02: Clinical Utility of Oncoguard Liver Test. February 2022-closed by Sponsor (9 screened)

92. Principal Investigator: Inventiva, 337HNAS20011: A randomized, double-blind, placebo-controlled, multicentre, Phase 3 study evaluating long-term efficacy and safety of lanifibranor in adult patients with non-cirrhotic non-alcoholic steatohepatitis (NASH) and fibrosis 2 (F2)/fibrosis 3 (F3) stage of liver fibrosis. (Patient enrollment time - 5 years) May 2022-ongoing (10 screened, 1 randomized)

93. Principal Investigator: Citius, 143-11351-202: A Randomized, Dose-Ranging, Double Blind Study to Demonstrate the Safety and Efficacy of a CITI-002 Cream in the Seven Day Twice-Daily Treatment of Grade II or III Hemorrhoids. August 2022-July 2023 (6 screened, 3 randomized)

94. Principal Investigator: ReStalsis, RF-001: ReStalsis Interferential Therapy (IFT) for the Treatment of Chronic Constipation. July 2022-August 2023 (8 screened, 3 randomized)

95. Principal Investigator: Braintree BLI5100-301: A Phase 3, Double-Blind, Randomized, Two-Phase, Active Controlled Study to Evaluate the Efficacy and Safety of Tegoprazan in Patients With Erosive Esophagitis. November 2022-ongoing (120 screened, 8 randomized)

96. Principal Investigator: Braintree BLI5100-302: A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Tegoprazan in Patients With Non-Erosive Reflux Disease. November 2022-ongoing (86 screened, 8 randomized)