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NCT02120027 · ClinicalTrials.gov registry record · Phase 3
52-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.
- Terminated
- Registry status
- Phase 3
- Development phase
- 558
- Enrollment target
NCT02120027: Clinical Trial Phase 3 study, sponsored by Menarini Group.
NCT02120027 is a Phase 3 study that was terminated before completion, run by Menarini Group. The registered enrollment target is 558 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (28% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02120027, a Phase 3 study, was terminated before completion, sponsored by Menarini Group.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 558 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 24-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 (patients reported their worst abdominal pain on a 0 to 10 NRS scale, where 0 corresponds to no pain and 10 corresponds to worst possible pain); * Stool consistency response: decrease of at least 50% in the number of days per week with at leas
Interventions
- DRUG Placebo
- DRUG Ibodutant 10 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 558 participants |
| Start Date | 2014-02 |
| Est. Completion | 2015-11 |
| Phase | Phase 3 |
Why NCT02120027 stopped before completion
NCT02120027 is an interventional study that assigns participants to a tested intervention. The registered 558 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 (28% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02120027 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02120027 about?
NCT02120027 is a clinical study titled "52-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 NCT02120027?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 558 participants. The study started on 2014-02. Estimated completion is 2015-11.
What interventions are being tested in trial NCT02120027?
The interventions under investigation include: Placebo (DRUG), Ibodutant 10 mg (DRUG).
Who is sponsoring clinical trial NCT02120027?
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 NCT02120027's enrollment target sits among peer trials
558 673rd of 2000 higher than 1,327 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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