drugset / Trial / NCT01303224

Ibodutant for Relief of Irritable Bowel Syndrome With Diarrhoea (IBS-D)

NCT01303224 ↗

Phase 2 Completed 565 enrolled Menarini Group
RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start
2010-10
Primary completion
2012-05
Completion
2012-07

Outcome

Met primary endpoint

paper ibodutant 10 mg demonstrated significant superiority over placebo in females (p=0.003) PMID 27196574 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Ibodutant Small molecule 1 mg Oral
Subject Ibodutant Small molecule 3 mg Oral
Subject Ibodutant Small molecule 10 mg Oral