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

ClinicalTrials.gov ID: NCT02107196

Public ClinicalTrials.gov record NCT02107196. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Oct 21, 2026, 7:35 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT02107196
Recruitment status: Completed
Study type: Interventional
Phase: Phase 3
Lead sponsor: Menarini Group; Industry
Enrollment: 535 participants

Conditions and interventions

Conditions

Irritable Bowel Syndrome With Diarrhea

Interventions

Ibodutant 10 mg Drug
Placebo Drug

Drug

Eligibility (public fields only)

Age range: 18 Years and older
Sex: Female
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Mar 2014 (Type not available)
Primary completion: Jun 2015 (Actual)
Completion: Jun 2015 (Actual)
Last update posted: Jan 19, 2017

2014 – 2015

United States locations

U.S. sites: 65
U.S. states: 24
U.S. cities: 59

Facility	City	State	ZIP	Site status
Not listed	Huntsville	Alabama	35802	—
Not listed	Sherwood	Arizona	72120	—
Not listed	Little Rock	Arkansas	72205	—
Not listed	Artesia	California	90701	—
Not listed	Chula Vista	California	91910	—
Not listed	Encino	California	91436	—
Not listed	Mission Hills	California	91345	—
Not listed	Sacramento	California	95821	—
Not listed	San Diego	California	92123	—
Not listed	Upland	California	91786	—
Not listed	Littleton	Colorado	80127	—
Not listed	Bristol	Connecticut	06010	—
Not listed	Boynton Beach	Florida	33426	—
Not listed	Brandon	Florida	33511	—
Not listed	Brooksville	Florida	34601	—
Not listed	Coral Gables	Florida	33134	—
Not listed	Gainesville	Florida	32607	—
Not listed	Hialeah	Florida	33012	—
Not listed	Jupiter	Florida	33458	—
Not listed	Miami	Florida	33125	—
Not listed	Miami	Florida	33165	—
Not listed	Miami	Florida	33175	—
Not listed	Miami	Florida	33185	—
Not listed	Miami Lakes	Florida	33014	—
Not listed	Addison	Illinois	60101	—
Not listed	Chicago	Illinois	60604	—
Not listed	Augusta	Kansas	67010	—
Not listed	Newton	Kansas	67114	—
Not listed	Wichita	Kansas	67205	—
Not listed	Lexington	Kentucky	40509	—
Not listed	Madisonville	Kentucky	42431	—
Not listed	Owensboro	Kentucky	42303	—
Not listed	Crowley	Louisiana	70526	—
Not listed	Baltimore	Maryland	21215	—
Not listed	Ann Arbor	Michigan	48106	—
Not listed	Chesterfield	Michigan	48047	—
Not listed	Saginaw	Michigan	48604	—
Not listed	Troy	Michigan	48098	—
Not listed	Las Vegas	Nevada	89128	—
Not listed	Hartsdale	New York	10530	—
Not listed	Fayetteville	North Carolina	28304	—
Not listed	Greensboro	North Carolina	27408	—
Not listed	Fargo	North Dakota	58103	—
Not listed	Akron	Ohio	44302	—
Not listed	Cincinnati	Ohio	45219	—
Not listed	Cincinnati	Ohio	45242	—
Not listed	Cleveland	Ohio	44122	—
Not listed	Columbus	Ohio	43214	—
Not listed	Dayton	Ohio	45432	—
Not listed	Reading	Pennsylvania	19606	—
Not listed	Greer	South Carolina	29650	—
Not listed	Simpsonville	South Carolina	29681	—
Not listed	Chattanooga	Tennessee	37421	—
Not listed	Knoxville	Tennessee	37912	—
Not listed	Knoxville	Tennessee	37919	—
Not listed	Nashville	Tennessee	37205	—
Not listed	Smyrna	Tennessee	37167	—
Not listed	Beaumont	Texas	77701	—
Not listed	Houston	Texas	77052	—
Not listed	Houston	Texas	77089	—
Not listed	Hurst	Texas	76054	—
Not listed	San Antonio	Texas	78229	—
Not listed	Ste. Channelview	Texas	77530	—
Not listed	West Jordan	Utah	84088	—
Not listed	Morgantown	West Virginia	26505	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 62 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT02107196, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Jan 19, 2017 · Synced Oct 21, 2026

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT02107196 live on ClinicalTrials.gov.

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