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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. 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) NCT02605837

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