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NCT02107196 · ClinicalTrials.gov registry record · Phase 3
12-Week Efficacy and Safety Study of Ibodutant in Women With Irritable Bowel Syndrome With Diarrhea (IBS-D)
A Phase 3 study, sponsored by Menarini Group.
- Completed
- Registry status
- Phase 3
- Development phase
- 535
- Enrollment target
NCT02107196: Completed Phase 3 study, sponsored by Menarini Group.
NCT02107196 is a Phase 3 study that has completed, run by Menarini Group. The registered enrollment target is 535 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (31% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02107196, a Phase 3 study, has completed, sponsored by Menarini Group.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 535 participants
- Enrollment target
Study Summary
Irritable Bowel Syndrome with diarrhoea (IBS-D) is a functional gastrointestinal disorder characterised by chronic or recurrent abdominal pain or discomfort and diarrhoea. This trial aims at the evaluation of the efficacy and safety of oral ibodutant 10 mg once daily as compared to placebo in women with IBS-D over a 12-week treatment period.
Primary Outcome
The patient will be considered a weekly responder if she meets both of the following criteria in the same week: * Abdominal pain response: decrease in weekly average of worst abdominal pain score in the past 24 hours of at least 30% compared with baseline; * Stool consistency response: decrease of at least 50% in the number of days per week with at least one stool that has a consistency of Type 6 or 7 compared with baseline. The patients reported Bristol Stoll Chart score based on a 1 to 7 scal
Interventions
- DRUG Placebo
- DRUG Ibodutant 10 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 535 participants |
| Start Date | 2014-03 |
| Est. Completion | 2015-06 |
| Phase | Phase 3 |
What the finished NCT02107196 record still lists
NCT02107196 is an interventional study that assigns participants to a tested intervention. The registered 535 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (31% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02107196 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02107196 about?
NCT02107196 is a clinical study titled "12-Week Efficacy and Safety Study of Ibodutant in Women With Irritable Bowel Syndrome With Diarrhea (IBS-D)". Irritable Bowel Syndrome with diarrhoea (IBS-D) is a functional gastrointestinal disorder characterised by chronic or recurrent abdominal pain or discomfort and diarrhoea. This trial aims at the evaluation of the efficacy and safety of oral ibodutant 10 mg once daily as compared to placebo in women ...
What is the current status of trial NCT02107196?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 535 participants. The study started on 2014-03. Estimated completion is 2015-06.
What interventions are being tested in trial NCT02107196?
The interventions under investigation include: Placebo (DRUG), Ibodutant 10 mg (DRUG).
Who is sponsoring clinical trial NCT02107196?
This trial is sponsored by Menarini Group, which has 9 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02107196's enrollment target sits among peer trials
535 702nd of 2000 higher than 1,298 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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