Linaclotide Safety & Efficacy Functional Constipation in Ages 6-17yrs
Research type
Research Study
Full title
A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Safety and Efficacy Study of Linaclotide Administered Orally to Children, Ages 6 to 17 Years, With Functional Constipation (FC)
IRAS ID
272260
Contact name
Andrea Sawdon
Contact email
Sponsor organisation
Allergan Ltd
Eudract number
2019-001500-38
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
63,290, IND
Duration of Study in the UK
1 years, 1 months, 10 days
Research summary
Functional constipation (FC) is a common healthcare problem in children of all ages, with a worldwide prevalence ranging between 0.7% and 29.6%. Symptoms include infrequent, hard stools and painful defaecation. These symptoms can have a severe impact on a child’s quality of life and may lead to school absenteeism and substantial costs related to healthcare utilisation. There are currently no approved products for FC in children. Thus, effective treatments are needed to provide symptomatic relief in children and adolescents with FC.
Linaclotide is an orally administered investigational drug that is approved in the United States, Canada, Japan, and Mexico for the treatment of irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation, and in China, the European Union, Hong Kong, Macau, and Switzerland for the treatment of IBS-C; and it is being studied in other regions.
A total of 326 participants are targeted to be randomised in a 1:1 ratio to receive either linaclotide (163 participants) or placebo (163 participants). The targeted participant population will include male and female participants. Randomisation will be stratified by age group only (6 to 11 years of age versus 12 to 17 years of age) with a minimum of 40% of participants within each age group. The study aims to enrol approximately 1/3 of the participants in the EU.
Approximately 140 sites from the United States of America, Canada, and the EMEA (Europe, Middle East, Africa) are expected to participate in the study. The study is sponsored by Allergan Ltd.
The study will include a total of 8 visits and will be up to 20 weeks in duration, a 2 to 4-week Screening Period, a 2 to 3 week Pre-intervention Period, followed by a 12-week double-blind Study Intervention Period and 1-week Post-intervention Period.REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
20/EM/0129
Date of REC Opinion
12 Jun 2020
REC opinion
Favourable Opinion