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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 is a Phase 3 study that has completed, run by Menarini Group. The registered enrollment target is 535 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02107196
The ClinicalTrials.gov registry entry for NCT02107196 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 535 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Menarini Group, which has 9 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02107196 reports 0 study locations.
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.
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