Successful Clinical Trials | GW Research in Chula Vista CA

Seeking New Clinical Trials
GW Research has performed clinical trials since our start in 1999. We have performed over 25 clinical trials in phase II, III and IV, in collaboration with multiple sponsors. We have always been attentive to our relationship with the sponsors and clinical research organizations. Since we have a limited bureaucratic structure, one on one communication with CRC, SI and PI have always been encouraged and performed. Most of the studies this organization has performed are in Gastroenterology and Internal Medicine.

Clinical Trials: Investigator Participation

1. A Randomized Study of Oral Lobucavir vs. Alpha Interferon in Subjects Chronically Infected with Hepatitis B Virus. June 1998- April 1999. Sponsor cancelled study.

2. 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. 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.

4. Aciphex Post Marketing Fast Trial 2000

5. A Comparative Efficacy Study of esomeprazole Magnesium 40mg and Lansoprazole 30mg in patients with erosive esophagitis. September 2000- December 2000.

6. 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.

7. 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.

8. 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)

9. 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. Dx-1 Non-Invasive pH Measurement Device Study. September 2004-October 2005

11. 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. 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

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

16. 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. 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

18. 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

19. 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

20. 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

21. 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

22. 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

23. 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

24. 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

25. 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

26. 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

27. 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 proctosigmoiditis: August 2010- June 2013

28. 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

29. 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

30. 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

31. 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

32. 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

33. 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

34. 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

35. 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

36. 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. Study Closed by Sponsor

37. 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. Study Closed by Sponsor

38. 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. 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

40. 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. Top Enroller.

41. 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. Top Enroller.

42. 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

43. 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

44. 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. Top Enroller.

45. 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 NCT01880424

46. 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

47. 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 (CIC) NCT02291679

48. 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 NCT02605837

49. 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 NCT02621892.

50. 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

51. 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 NCT02637557

52. 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

53. 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. NCT02618187

54. 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. NCT02267525

55. 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

56. 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 NCT02704403

57. 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 NCT02784444

58. 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– August 2023 NCT02548351

59. 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

60. 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. Top Enroller.

61. RedHill Pharmaceutical, 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. Top Enroller.

62. A Safety and Efficacy Comparison of BLI4700 Bowel Preparation
versus an FDA-approved Comparator in Adult Subjects prior to Colonoscopy. January 2018 – November 2018. Top Enroller.

63. A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy of Tradipitant in Relieving Symptoms of Gastroparesis. February 2018

64. 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

65. 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

66. 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

67. 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

68. 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

69. 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

70. 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

71. 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 – May 2025

72. 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

73. 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 – October 2020

74. 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

75. 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

76. Arena Pharmaceutical, 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

77. 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-April 2021

78. 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 201-

79. 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

80. 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

81. 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

82. 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

83. 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

84. 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

85. 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 2023

86. 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

87. 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

88. 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

89. 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-March 2024

90. 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

91. Exact Sciences 2021-02: Clinical Utility of Oncoguard Liver Test. February 2022-July 2022 closed by Sponsor

92. Inventiva, 337HNAS20011: A randomised, 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-February 2025

93. 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

94. ReStalsis, RF-001: ReStalsis Interferential Therapy (IFT) for the Treatment of Chronic Constipation. July 2022- August 2023

95. 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- September 2025. Top Enroller.

96. 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-July 2024

97. HighTide, HTD1801.PCT014 A Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of HTD1801 in Adult Subjects with Nonalcoholic Steatohepatitis (NASH) and Liver Fibrosis who Have Type 2 Diabetes or Pre-Diabetes April 2023-January 2024

98. Salix RNLC3131: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of Rifaximin Soluble Solid Dispersion (SSD) Tablets for the Delay of Encephalopathy Decompensation in Cirrhosis (RED-C). May 2023- May 2024

99. Braintree BLI5100-303: A Phase 3, Double-Blind, 29-Week Follow-Up Study to Evaluate the Long-Term Safety of Tegoprazan in Patients With Gastroesophageal Reflux Disease August 2023- January 2025

100. Celldex, CDX0159-08: A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Barzolvolimab (CDX-0159) in Adults with Active Eosinophilic Esophagitis (The "EvolvE" Study) September 2023-February 2025

101. Akero AK-US-001-0105: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Efruxifermin in Subjects with Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH) and Fibrosis September 2023-December 2024

102. Akero AK-US-001-0107: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Efruxifermin in Subjects with Non-Invasively Diagnosed Nonalcoholic Steatohepatitis (NASH)/Nonalcoholic Fatty Liver Disease (NAFLD)
September 2023-December 2024

103. CinDome CIN-102-123: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of CIN-102 (Deudomperidone) in Adult Subject With Diabetic Gastroparesis. March 2024-February 2025

104. Phathom EoE-201: A Phase 2, Randomized, Double-Blind, Multi-Center, 3-Part Study in Adult Subjects with Eosinophilic Esophagitis (EoE) to Evaluate the Safety and Efficacy of Vonoprazan 20 mg Compared to Placebo After 12 Weeks and to Evaluate the Safety and Efficacy of Vonoprazan 20 mg Up to 24 Weeks. November 2025- ongoing

105. Ardelyx TEN-03-301; A 26-Week, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of Tenapanor for the Treatment of Chronic Idiopathic Constipation (CIC) in Adults. December 2025- ongoing