Linaclotide for abdominal distension V1
Research type
Research Study
Full title
A Phase 4, Single-centre, Randomised, Double-blind, Placebo-controlled, Parallel-group, Fixed-dose Study of the Effect of Linaclotide on Abdominal Girth in Participants with Irritable Bowel Syndrome with Constipation.
IRAS ID
165834
Contact name
Peter Whorwell
Contact email
Sponsor organisation
Ironwood Pharmaceuticals, Inc.
Eudract number
2016-000818-29
Duration of Study in the UK
1 years, 10 months, 30 days
Research summary
Research Summary:
Abdominal Distension, which is characterised by an increase in abdominal girth, is a common and very intrusive symptom of Irritable Bowel Syndrome (IBS). It is notoriously difficult to treat and is more common in constipation predominant IBS. Linaclotide has recently been introduced for the treatment of constipation predominant IBS and may improve the subjective symptom of bloating. Approximately 50% of patients complaining of bloating also experience abdominal distension and therefore it is possible that this drug could possibly reduce abdominal distension.We have developed the technique of abdominal inductance plethymosography and, over the years have gradually refined this technique and upgraded the system so that it now reliably records abdominal girth over 24 hours. It is intended to use this equipment to establish whether Linaclotide reduces abdominal distension in constipation predominant IBS by undertaking a controlled clinical trial of Linaclotide vs Placebo.
Summary of Results:
: MCP-103-403: Clinical Study Report Lay Summary 1. STUDY This study is a Phase 4 post-approval study which occurs after the drug has been approved and, can, therefore, be prescribed by doctors. These types of studies are not considered needed to approve the drug, but are considered important for informing the use of the drug.
Researchers look at the results of many studies to understand which drugs work and how they work. It takes lots of people in many studies all around the world to advance medical science.
This summary only shows the results from this one study. Other studies may find different results.REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
16/NW/0089
Date of REC Opinion
16 Jun 2016
REC opinion
Further Information Favourable Opinion