A Study of Crofelemer to Treat Diarrhea Irritable Bowel Syndrome
A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of TRN 002 (Crofelemer) for the Symptomatic Treatment of Diarrhea-Predominant Irritable Bowel Syndrome (d-IBS)
Sponsor: Bausch Health Americas, Inc.
A PHASE2 clinical study on Colonic Diseases and Diarrhea, this trial is completed. The trial is conducted by Bausch Health Americas, Inc. and has accumulated 9 data snapshots since 2004. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.
Study Description(click to expand)The investigational drug is a natural product taken from a plant that grows in South America. The study medication will be administered 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.
The investigational drug is a natural product taken from a plant that grows in South America. The study medication will be administered 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.
Status Flow
Change History
9 versions recorded-
Sep 2025 — Present [monthly]
Completed PHASE2
-
Sep 2024 — Sep 2025 [monthly]
Completed PHASE2
-
Jul 2024 — Sep 2024 [monthly]
Completed PHASE2
-
Jan 2021 — Jul 2024 [monthly]
Completed PHASE2
-
Dec 2019 — Jan 2021 [monthly]
Completed PHASE2
▶ Show 4 earlier versions
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Jun 2019 — Dec 2019 [monthly]
Completed PHASE2
-
Jun 2018 — Jun 2019 [monthly]
Completed PHASE2
-
Feb 2017 — Jun 2018 [monthly]
Completed PHASE2
-
Jan 2017 — Feb 2017 [monthly]
Completed PHASE2
First recorded
Dec 2004
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Bausch Health Americas, Inc.
For direct contact, visit the study record on ClinicalTrials.gov .