Ibodutant for relief of irritable bowel syndrome (Nak-06)

• Research type

  Research Study

• Full 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 DIARRHOEA (IBS-D).

• IRAS ID

  138682

• Contact name

  Douglas McKeith

• Contact email

  douglas.mckeith@nhs.net

• Sponsor organisation

  Menarini Ricerche S.p.A.

• Eudract number

  2013-000894-56

• 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/0016

• Date of REC Opinion

  7 Mar 2014

• REC opinion

  Further Information Favourable Opinion