Completed PHASE3 INTERVENTIONAL 2-arm NCT02107196

12-Week Efficacy and Safety Study of Ibodutant in Women With Irritable Bowel Syndrome With Diarrhea (IBS-D) (IRIS-3)

A 12-Week Double-blind, Randomised, Placebo-controlled, Parallel Group Phase III Study, Followed by a 4-Week Randomised Withdrawal Period to Evaluate the Efficacy and Safety of Oral Ibodutant 10 mg Once Daily in Female Patients With Irritable Bowel Syndrome With Diarrhea

Sponsor: Menarini Group

Conditions Irritable Bowel Syndrome With Diarrhea

Interventions Ibodutant 10 mg Placebo

Updated 7 times since 2017 Last updated: Nov 18, 2016 Started: Mar 31, 2014 Primary completion: Jun 30, 2015 Completion: Jun 30, 2015

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT02107196, this PHASE3 trial focuses on Irritable Bowel Syndrome With Diarrhea and remains completed. Sponsored by Menarini Group, it has been updated 7 times since 2014, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

Change History

7 versions recorded

Sep 2025 — Present [monthly]

Completed PHASE3
Sep 2024 — Sep 2025 [monthly]

Completed PHASE3
Jul 2024 — Sep 2024 [monthly]

Completed PHASE3
Jan 2021 — Jul 2024 [monthly]

Completed PHASE3
Jun 2018 — Jan 2021 [monthly]

Completed PHASE3

▶ Show 2 earlier versions

Feb 2017 — Jun 2018 [monthly]

Completed PHASE3
Jan 2017 — Feb 2017 [monthly]

Completed PHASE3

First recorded

Mar 2014

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Menarini Group

Data source: Menarini Group

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Addison, United States , Akron, United States , Ann Arbor, United States , Artesia, United States , Augusta, United States , Badalona, Spain , Baltimore, United States , Barcelona, Spain , Bari, Italy , Beaumont, United States and 99 more locations