Clinical Trials Logo

Clinical Trial 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 the neurokinin type 2 receptor antagonist Ibodutant in improving IBS-D symptoms.


Clinical Trial Description

The study evaluates the efficacy and safety of three doses of ibodutant, given once daily for 8 weeks versus placebo in IBS-D patients. Efficacy is evaluated in terms of overall symptom relief and abdominal pain/discomfort relief after 8 weeks of treatment. The clinical phase of the study comprises a 2-week run-in period (treatment-free),an 8-week double-blind treatment period and a 2-week treatment withdrawal period, resulting in a 10-week overall duration of the study for each patient.

Patients report their IBS-related symptoms daily in an electronic diary (web-and telephone based)during all periods of the study. ;


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01303224
Study type Interventional
Source Menarini Group
Contact
Status Completed
Phase Phase 2
Start date October 2010
Completion date July 2012

See also
  Status Clinical Trial Phase
Completed NCT00552565 - Efficacy Study of Rezular (Arverapamil) in the Treatment of Irritable Bowel Syndrome With Diarrhea (IBS-D) Phase 3
Completed NCT04950296 - To Study the Efficacy and Safety of L. Plantarum UALp-05TM in Diarrhea- Predominant-irritable Bowel Syndrome N/A
Completed NCT02959983 - Efficacy of Eluxadoline in the Treatment of Irritable Bowel Syndrome With Diarrhea in Patients With Inadequate Control of Symptoms With Prior Loperamide Use Phase 4
Withdrawn NCT02320318 - 12-Week Efficacy and Safety Study of Ibodutant in Women With Irritable Bowel Syndrome With Diarrhea (IBS-D) Phase 3
Recruiting NCT05646186 - Personalized Dietary Intervention Based on Microbiome Analysis vs FODMAP Diet for Irritable Bowel Syndrome N/A
Recruiting NCT03806959 - Interest of Pan-capsule in Symptomatic Patients Suspected of Irritable Bowel Syndrome Requiring Colonoscopy N/A
Completed NCT04129619 - A Comparison of the Effects of ORP-101 Versus Placebo in Adult Patients With Irritable Bowel Syndrome With Diarrhea (IBS-D) Phase 2
Recruiting NCT04855799 - GI Permeability Change in Response to Aquamin® Phase 2
Completed NCT04662957 - Multi Strain Probiotic Preparation in Patients With Irritable Bowel Syndrome N/A
Completed NCT04557215 - Efficacy and Safety of Rifaximin With NAC in IBS-D Phase 1/Phase 2
Enrolling by invitation NCT05311293 - Study on the Molecular Mechanism of Diarrhea-predominant Irritable Bowel Syndrome With Anxiety and Depression Based on Multi-omics Correlation Analysis
Completed NCT05277428 - Clinical Study to Evaluate the IBS Symptoms Improving Effect and Safety of GTB1 N/A
Not yet recruiting NCT03221790 - Effect of FODMAPs on Mucosal Inflammation in IBS Patients N/A
Completed NCT03557788 - Changes in Microbiota and Metabolomic Profile Between Rifaximin Responders and Non-responders In Diarrhoea-Predominant Irritable Bowel Syndrome Phase 4
Completed NCT02757105 - Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial of BEKINDA (Ondansetron 12 mg Bimodal Release Tablets) for Diarrhea Predominant Irritable Bowel Syndrome (IBS-D) Phase 2
Enrolling by invitation NCT06432569 - Evaluation of Butyrate and Palmitoylethanolamide in IBS Patients (B/P3_1) N/A
Recruiting NCT04830410 - The Effects of Carbohydrates in Irritable Bowel Syndrome N/A
Completed NCT03245645 - FODMAP Reintroduction in Irritable Bowel Syndrome N/A
Completed NCT02107196 - 12-Week Efficacy and Safety Study of Ibodutant in Women With Irritable Bowel Syndrome With Diarrhea (IBS-D) Phase 3
Terminated NCT02120027 - 52-Week Efficacy and Safety Study of Ibodutant in Women With Irritable Bowel Syndrome With Diarrhea (IBS-D) Phase 3