|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Trine Pharmaceuticals |
|---|---|
| Information provided by: | Trine Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00101725 |
Purpose
This study is designed to evaluate the safety and effectiveness of an investigational drug, TRN-002 (crofelmer) to relieve the symptoms of diarrhea-predominant irritable bowel syndrome (IBS).
| Condition | Intervention | Phase |
|---|---|---|
|
Irritable Bowel Syndrome Colonic Diseases Diarrhea Gastrointestinal Disease |
Drug: crofelmer |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of TRN 002 (Crofelmer) for the Symptomatic Treatment of Diarrhea-Predominant Irritable Bowel Syndrome (d-IBS) |
| Estimated Enrollment: | 240 |
| Study Start Date: | December 2004 |
| Estimated Study Completion Date: | November 2005 |
The investigational drug is a natural product taken from a plant that grows in South America. The study medication will be adminstered orally twice a day. Subjects who are eligible to participate will have a 75% chance of receiving TRN-002 and a 25% chance of receiving placebo (a substance that looks similar to TRN 002 but has no activity). Subjects will not be able to remain on certain standard IBS medications (antidiarrheals) while participating in the study. The total duration is 16 weeks.
The study requires five study visits that include physical exams, ECG and blood draws for laboratory studies. A colon procedure (such as a colonoscopy or flexible sigmoidoscopy) may also be required if it has not been performed since your diagnosis and within the last 5 years. Participants will be asked to make daily entries into a touch-tone telephone diary on a daily basis.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Show 29 Study Locations| Study Director: | David Rosenbaum, PhD | Trine Pharmaceuticals |
More Information
| Study ID Numbers: | TRN 002 201, TRN 002 201 |
| Study First Received: | January 12, 2005 |
| Last Updated: | October 31, 2005 |
| ClinicalTrials.gov Identifier: | NCT00101725 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Diarrhea IBS Irritable Bowel Syndrome Abdominal pain |
|
Signs and Symptoms Pathologic Processes Disease Digestive System Diseases Diarrhea Signs and Symptoms, Digestive |
Gastrointestinal Diseases Syndrome Irritable Bowel Syndrome Colonic Diseases Intestinal Diseases Colonic Diseases, Functional |