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Dr. Gregory Wiener CV

 

BOARD CERTIFIED MEDICAL SPECIALTIES
Gastroenterology & Internal Medicine

EDUCATION AND TRAINING:

7/85 to 6/87 Fellow in Gastroenterology

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.

1983 to 1985 Resident in Internal Medicine

1982 to 1983 Intern in Medicine
Baylor College of Medicine
Houston, Texas 77030
Chief of Department: Edward Lynch, M.D.

2/80 to 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

1975 to 1980 National University of El Salvador Medical School

San Salvador, El Salvador, Central America

1971 to 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 Assistant. Professor, Gastroenterology

University of California, San Diego (UCSD)

MEMBERSHIPS:

1982 American College of Physicians

1985 American Gastroenterology Association

1986 American College of Gastroenterology

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

STAFF PRIVILEGES:

1987-2002 Scripps Mercy Hospital, Chula Vista, CA, 91910

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

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

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

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., G.J., 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: Reproducible 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.

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.

Gastroenterolgy, 1986; 80:A1691

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 Esophagogastric  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 Gastroenterology  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):S26,2005.(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

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 5,2009

3.CITI CERTIFICATION Basic Course in the Protection of Human Subjects and Good Clinical Practices/University of Miami (Scripps Hospital Affiliation Program.) Sept.2009

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. (Three patients enrolled and screened)
  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.  Protocol: s3b30011 (1999-2000)  (8 screened and 2 enrolled)
  4. Principal Investigator:  Aciphex Post Marketing Fast Trial. (10 patients enrolled and screened)  (2000)
  5. Principal Investigator:  A Comparative Efficacy Study of esomeprazole Magnesium 40mg and Lansoprazole 30mg in patients with erosive esophagitis. (Protocol 267) September 2000- December 2000. (32 patients enrolled and 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 re-randomized treatment of period in diarrhea-predominant Irritable Bowel Syndrome Subjects. (12 enrolled, 4 screen failed)
  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 enrolled, 4 screen failures)
  8. Principal Investigator:  A randomized, double-blind, placebo-controlled, parallel group, multicenter study to assess the efficacy and safety of repeated treatment with tegaserod 6 mg  BID and placebo in female patients with irritable bowel syndrome with constipation (IBS-C) (20 patients enrolled and 23 patients screened)
  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. Sept 2004-Oct 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- 48 patients enrolled, 25 screen failures) Nov.2005-2006
  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 Protocol A3191331. Jan. 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. 2-12/2008.
  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). 7/2008 -6/2009 (30 screened/9 randomized)
  18. Principal Investigator: A Randomized Double-Blind parallel study of Rabeprazole Extended release 50mg versus Esomeprazole 40 mg for healing and symptomatic relief of moderate to severe erosive gastroesophageal reflux disease (GERD). 3/2008 -6/2009 (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). 3/2008 -6/2009 (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. 11/08 -4/2009 (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. 1/09 (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. 1/09 – 09/2011 (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  2009-04/2012 (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. 9/2009 (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). 9/2010 – 3/2013 (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 – 03/2012 (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: 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: 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: 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: 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-ongoing (14 screened/2 randomized)
  34. Principal Investigator:  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:  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:  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 )
  37. Principal Investigator:  A Multi-Center, Open-Label, Safety and Tolerability Extension Trial of 5mg and 10g  Elobixibat Daily in the Treatment of Chronic Idiopathic Constipation: March 2014 – March 2014(3 randomized)
  38. Principal Investigator: 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: 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 – ongoing (20 screened/10 randomized)
  40. Principal Investigator: 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 – ongoing (55 screened/26 randomized to date)
  41. Principal Investigator: An Open-Label Extension (OLE), Long-term Safety and Tolerability Study of Plecanatide in Patients with Chronic Idiopathic Constipation (CIC).September 2013 – ongoing (23 rollover)
  42. Principal Investigator: 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 – ongoing (6 screened/1 randomized to date) NCT02107196
  43. Principal Investigator: A 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.August2014-October 2014 (12 screened)
  44. Principal Investigator: (Ironwood Gastroparesis) 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. November2014 – ongoing (63screened/12 randomized)
  45. Principal Investigator: 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)
  46. Principal Investigator: (Sucampo IBS-M/IBS-U) 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 – ongoing NCT02544152
  47. Principal Investigator:  (Ironwood IBS-C) 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) February 2015 – July 2015 ( 9 screened/4 randomized) D5630C00001
  48. Principal Investigator: (Ironwood CIC) A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial of Linaclotide (72 ug or 145 ug) Administered Orally for 12 Weeks to Patients With Chronic Idiopathic Constipation February 2015- October – 2015 ( 32 screened/18 randomized) (CIC) NCT02291679
  49. Principal Investigator: (Shire EOE) 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 – ongoing (EOE) NCT0260583
  50. 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.
  51. 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 – ongoing. (8 screened / 4 randomized)
  52. 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. December 2016 – ongoing (19 screened / 5 randomized) NCT02548351
  53. 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 – ongoing. (4 screened/1 randomized) NCT02784444
  54. 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 – ongoing (2 screened) NCT02704403
  55. 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 – ongoing. (24 screened/ 11 randomized) NCT02267525
  56. 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 – ongoing. (3 screened/ 3 randomized) NCT02618187
  57. Principal Investigator: Synergy Therapeutics, 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 – ongoing. (10 screened/ 8 randomized
  58. 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 – ongoing. (28 screened/ 7 randomized)  NCT02637557
  59. 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 – ongoing. (17 screened/ 10 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 – Ongoing. (101 Screened / 90 Randomized)

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