Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01177410 · ClinicalTrials.gov registry record · Phase 2
Mesalamine Granules for Irritable Bowel Syndrome (IBS) With Diarrhea
A Phase 2 study, sponsored by Bausch Health Americas.
- Completed
- Registry status
- Phase 2
- Development phase
- 148
- Enrollment target
NCT01177410: Completed Phase 2 study, sponsored by Bausch Health Americas.
NCT01177410 is a Phase 2 study that has completed, run by Bausch Health Americas. The registered enrollment target is 148 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (11% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01177410, a Phase 2 study, has completed, sponsored by Bausch Health Americas.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 148 participants
- Enrollment target
Study Summary
The purpose of this study is to determine the daily dose of mesalamine granules that will provide adequate relief from symptoms of IBS with diarrhea.
Primary Outcome
A weekly responder in abdominal pain is defined as a ≥30% improvement from baseline in the weekly average abdominal pain score on a 10-point scale (0=no pain - 10= worst possible pain). A weekly responder in stool consistency is defined as ≥50% reduction in the number of days in a week with stool consistency of Type 6 or 7 compared with baseline using the Bristol Stool Scale. Monthly responders are subjects who are weekly responders in both abdominal pain and stool consistency for at least two o
Interventions
- DRUG Placebo
- DRUG Mesalamine Granules 750 mg
- DRUG Mesalamine Granules 1500 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 148 participants |
| Start Date | 2010-07 |
| Est. Completion | 2011-08 |
| Phase | Phase 2 |
What the finished NCT01177410 record still lists
NCT01177410 is an interventional study that assigns participants to a tested intervention. The registered 148 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (11% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01177410 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01177410 about?
NCT01177410 is a clinical study titled "Mesalamine Granules for Irritable Bowel Syndrome (IBS) With Diarrhea". The purpose of this study is to determine the daily dose of mesalamine granules that will provide adequate relief from symptoms of IBS with diarrhea.
What is the current status of trial NCT01177410?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 148 participants. The study started on 2010-07. Estimated completion is 2011-08.
What interventions are being tested in trial NCT01177410?
The interventions under investigation include: Placebo (DRUG), Mesalamine Granules 750 mg (DRUG), Mesalamine Granules 1500 mg (DRUG).
Who is sponsoring clinical trial NCT01177410?
This trial is sponsored by Bausch Health Americas, which has 168 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01177410's enrollment target sits among peer trials
148 491st of 2000 higher than 1,506 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00739362 · 148 participants · Phase 2
Effects of Brain Stimulation on Food Intake and Behavioral Weight Loss Treatment
- NCT03161223 · 148 participants · Phase 1
Durvalumab in Different Combinations With Pralatrexate, Romidepsin and Oral 5-Azacitidine for Lymphoma
- NCT03858231 · 148 participants · Phase 4
Opioids Versus Non-Opioids Postoperative After Knee Arthroscopic Surgery
- NCT04486352 · 148 participants · Phase 1
A Study of Targeted Agents for Patients With Recurrent or Persistent Endometrial Cancer
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia