UK Clinical Experience with Linaclotide for Patients with IBS-C
Research type
Research Study
Full title
A Non-Interventional Study to Describe Early UK Clinical Experience with Linaclotide for Patients with Irritable Bowel Syndrome with Constipation
IRAS ID
161445
Contact name
Mark Rance
Contact email
Sponsor organisation
Allergan Pharmaceutical Ireland
Clinicaltrials.gov Identifier
NIHR CRN Reference, GAST 3605
Duration of Study in the UK
1 years, 6 months, 31 days
Research summary
This is a multi-centre, prospective, non-interventional, UK research study. This early clinical experience study is designed to understand the effect of linaclotide on patients’ quality of life and irritable bowel syndrome (IBS) symptoms, the safety of linaclotide and the characteristics of patients who are prescribed linaclotide in real world clinical practice.
The study will be conducted in the gastroenterology departments of 7-9 secondary / tertiary care centres in the UK. Centres will be selected where linaclotide is available for prescribing (eg by local formulary) and where clinicians are known to be using linaclotide in the management of adult patients with moderate to severe IBS with constipation (IBS-C).
Potential study participants will be identified prospectively as they are initiated on linaclotide in the course of routine clinical care in the participating centres and will be approached for consent to join the study. The decision to prescribe linaclotide is separate to patient enrolment in this study.
Consecutive eligible consenting patients enrolling in the study during the recruitment period (up to a maximum of 250 participants) will be included.
Patients will be asked to complete quality of life and disease severity questionnaires at 4 different time points; baseline (ie within 3 days of linaclotide initiation), 4 weeks, 12 weeks and 52 weeks, either in clinic, by post or online so there will be no extra hospital visits for the study. Patient characteristics, reported side effects and details of investigations and treatments for IBS will be collected from patients' hospital records. Data analysis will be conducted by pH Associates Ltd.REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
14/EE/1221
Date of REC Opinion
3 Dec 2014
REC opinion
Further Information Favourable Opinion