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A History of Successful Clinical Trials

A History of Successful 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 has 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. (1 patient enrolled, Sponsor canceled 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. (Three patients enrolled and screened)
  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. Protocol: s3b30011 (1999-2000) (8 screened and 2 enrolled)
  4. Aciphex Post Marketing Fast Trial. (10 patients enrolled and screened) (2000)
  5. 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. 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. 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. 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. 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. Sept 2004-Oct 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- 48 patients enrolled, 25 screen failures) Nov.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
  15. Anti-inflammatory 22 Drugs (NSAIDS) in Osteoarthritis Patience Protocol A3191331. Jan. 2007-2008.
  16. Multicenter, randomized, placebo-controlled, Double-Blinded Study of the Efficacy and Safety of Lubiprostone in patients with Opioid-induced Bowel Dysfunction..2008.
  17. 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.
  18. 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)
  19. 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)
  20. 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)
    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. 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. 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. 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. 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. 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. 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. 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. A Phase 3, Open-Label, Multicenter Study to Assess the Safety and Tolerability of Budesonide Foam in Subjects with
  29. Active Ulcerative Proctitis or Proctosigmoiditis: September 2011 – September 2013(1 randomized)
  30. 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)
  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: May 2012 – February 2014(14 screened/ 7 randomized)
  32. 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)
  33. 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)
  34. 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)
  35. 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 )
  36. 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 )
  37. 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 )
  38. 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)
  39. 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 )
  40. 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)
  41. 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)
  42. 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)
  43. 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
  44. 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)
  45. (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)
  46. 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)
  47. (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
  48. (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
  49. (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
  50. (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
  51. 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.
  52. 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)
  53. 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
  54. 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
  55. 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
  56. 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
  57. 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
  58. 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
  59. 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
  60. 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)
  61. 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) one of top enrolling sites
  62. 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) one of top enrolling sites
  63. A Safety and Efficacy Comparison of BLI4700 Bowel Preparationversus an FDA-approved Comparator in Adult Subjects prior to Colonoscopy January 2018 – November 2018 (12 Screened/12 Randomized) one of top enrolling sites
  64. A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy of Tradipitant in Relieving Symptoms of Gastroparesis February 2018 – ongoing (6 Screened)
  65. 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 – ongoing (23 Screened)
  66. 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 – ongoing (3 randomized rollovers)
  67. 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 – ongoing (10 screened)
  68. 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 – ongoing (30 screened/16 randomized)
  69. 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 – ongoing (13 screened)
  70. 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 – ongoing (22 screened)
  71. 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 – ongoing (7 screened)
  72. 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 November 2019 – ongoing (8 screened)
  73. Phathom Pharmaceuticals, Inc. 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 – ongoing (3 screened)
  74. 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 – ongoing (47 screened)
  75. 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)
  76. 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
  77. 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
  78. 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
  79. Allakos, Inc., A Prospective Study to Identify the Incidence of Eosinophilic Gastrointestinal Diseases and Elevated Tissue Mast Cells among Patients with Chronic Gastrointestinal Symptoms, March 2019
    Exact Sciences Act Fast 2018-07, Blood and Stool Sample Collection in Subjects with a Diagnosis of Colorectal Cancer or Colorectal Lesion, April 2019

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