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

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 24-week treatment period.

Timeline

Start

2014-02

Primary completion

2015-11

Completion

2015-11

Outcome

Missed primary endpoint

Stopped: “Because of negative results of the sister study NAK-06 and the low overall response rate at week 24.”

registry Ibodutant 10 mg vs Placebo; p = 0.949; Odds Ratio (OR) 0.986 (95% CI 0.64 to 1.53) NCT02120027 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ibodutant	Small molecule	10 mg	Oral

Indications