Ibodutant for relief of irritable bowel syndrome (Nak-07)
Research type
Research Study
Full title
A 52-WEEK, DOUBLE-BLIND, RANDOMISED, PLACEBO-CONTROLLED, PARALLEL-GROUP PHASE III STUDY WITH RE-RANDOMISATION AT WEEK 25 TO EVALUATE THE EFFICACY AND SAFETY OF ORAL IBODUTANT 10 MG ONCE DAILY IN FEMALE PATIENTS WITH IRRITABLE BOWEL SYNDROME WITH DIARRHOEA (IBS-D)
IRAS ID
138392
Contact name
Rajiv Sharma
Contact email
Sponsor organisation
Menarini Ricerche S.p.A.
Eudract number
2013-000895-14
ISRCTN Number
N/A
Research summary
Irritable bowel syndrome (IBS) is bowel disorder in which abdominal pain or discomfort is associated with defecation or a change in bowel habits. There are different classifications of IBS including IBS-D (IBS with diarrhea), IBS-D patients have loose stools more than 25% and hard stools less than 25% of the time. There is a high medical need for new agents which are potentially more effective and better tolerated in treating IBS-D.
This study aims to evaluate the safety and efficacy of a new drug called Ibodutant (10mg) taken once daily to reduce the symptoms caused in female patients with IBS-D
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
14/NE/0017
Date of REC Opinion
7 Mar 2014
REC opinion
Further Information Favourable Opinion