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NCT01327300 · ClinicalTrials.gov registry record · Phase 2
Efficacy of Mesalamine in Diarrhea-predominant Irritable Bowel Syndrome (dIBS)
A Phase 2 study, sponsored by University of Florida.
- Completed
- Registry status
- Phase 2
- Development phase
- 7
- Enrollment target
NCT01327300: Completed Phase 2 study, sponsored by University of Florida.
NCT01327300 is a Phase 2 study that has completed, run by University of Florida. The registered enrollment target is 7 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01327300, a Phase 2 study, has completed, sponsored by University of Florida.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 7 participants
- Enrollment target
Study Summary
The purpose of this study is to find whether treating patients with diarrhea predominant Irritable Bowel Syndrome (IBS) with an anti-inflammatory drug called Mesalamine will help improve their symptoms of diarrhea, bloating and abdominal pain.
Primary Outcome
Patients rated the severity of their GI symptoms. The GIS scale goes from 1 to 7 with 1 being the worse and 7 as the best score showing improvement in symptoms. The GIS was performed at week one and at week 12 during each of the interventions. The comparisons below list the mean difference for each intervention from baseline (BL) with standard deviations then we list the p-value for the differences of baseline to intervention are reported using the Mann-Whitney test with a two-tailed p value pro
Interventions
- OTHER Placebo
- DRUG Mesalamine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2010-03 |
| Est. Completion | 2012-03 |
| Phase | Phase 2 |
What the finished NCT01327300 record still lists
NCT01327300 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01327300 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01327300 about?
NCT01327300 is a clinical study titled "Efficacy of Mesalamine in Diarrhea-predominant Irritable Bowel Syndrome (dIBS)". The purpose of this study is to find whether treating patients with diarrhea predominant Irritable Bowel Syndrome (IBS) with an anti-inflammatory drug called Mesalamine will help improve their symptoms of diarrhea, bloating and abdominal pain.
What is the current status of trial NCT01327300?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 7 participants. The study started on 2010-03. Estimated completion is 2012-03.
What interventions are being tested in trial NCT01327300?
The interventions under investigation include: Placebo (OTHER), Mesalamine (DRUG).
Who is sponsoring clinical trial NCT01327300?
This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01327300's enrollment target sits among peer trials
7 1996th of 2000 higher than 5 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
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