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NCT01412372 · ClinicalTrials.gov registry record · Phase 3
The Effect of Long-Acting Mesalamine on Post-Infective Irritable Bowel Syndrome- A Pilot Study
A Phase 3 study, sponsored by University of Utah.
- Completed
- Registry status
- Phase 3
- Development phase
- 61
- Enrollment target
NCT01412372: Completed Phase 3 study, sponsored by University of Utah.
NCT01412372 is a Phase 3 study that has completed, run by University of Utah. The registered enrollment target is 61 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01412372, a Phase 3 study, has completed, sponsored by University of Utah.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 61 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the effects of long acting mesalamine (Lialda) in patients with Post-Infective Irritable Bowel Syndrome (PI-IBS). The investigators will evaluate gastrointestinal symptoms, IBS specific quality of life (IBS-QOL), and plasma cytokines before and after treatment with Lialda.
Primary Outcome
BSS score measured from sum of BSS items of abdominal pain severity, bloating severity, diarrhea severity, constipation severity, and how satisfied are you with bowel habits, and measured on a scale of 0% to 100%, 0 being not severe and 100 being very severe.
Interventions
- DRUG Placebo
- DRUG Mesalamine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 61 participants |
| Start Date | 2010-06 |
| Est. Completion | 2019-04-22 |
| Phase | Phase 3 |
What the finished NCT01412372 record still lists
NCT01412372 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 61 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01412372 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01412372 about?
NCT01412372 is a clinical study titled "The Effect of Long-Acting Mesalamine on Post-Infective Irritable Bowel Syndrome- A Pilot Study". The purpose of this study is to evaluate the effects of long acting mesalamine (Lialda) in patients with Post-Infective Irritable Bowel Syndrome (PI-IBS). The investigators will evaluate gastrointestinal symptoms, IBS specific quality of life (IBS-QOL), and plasma cytokines before and after treatmen...
What is the current status of trial NCT01412372?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 61 participants. The study started on 2010-06. Estimated completion is 2019-04-22.
What interventions are being tested in trial NCT01412372?
The interventions under investigation include: Placebo (DRUG), Mesalamine (DRUG).
Who is sponsoring clinical trial NCT01412372?
This trial is sponsored by University of Utah, which has 818 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01412372's enrollment target sits among peer trials
61 1803rd of 2000 higher than 197 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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
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