M21-572: Linaclotide for Functional Constipation (FC) in Pediatric Subjects, Ages 2 to 5 Years
Research type
Research Study
Full title
A Phase 3, Multicenter, Randomized, Double-blind, Parallel-group, Safety and Efficacy Study of Linaclotide versus Placebo in Pediatric Subjects, Ages 2 to 5 Years, with Functional Constipation (FC) with a 24-week Open-label Treatment Extension
IRAS ID
1006959
Contact name
Alice Butler
Contact email
Sponsor organisation
AbbVie Deutschland GmbH & Co. KG
Eudract number
2022-501946-31
ISRCTN Number
N/A
Clinicaltrials.gov Identifier
Research summary
Functional constipation (FC) is a common healthcare problem in children of all ages, potentially due to genetic predisposition, inadequate fiber and fluid intake, and immobility. Currently, there are no pharmacological therapies approved for the treatment of FC. This study will assess adverse events and change in disease activity with linaclotide therapy in participants with FC.
Linaclotide is an approved drug being developed for the treatment of FC in paediatric patients who meet modified Rome IV criteria for childhood FC. In Part 1 of this study, participants are placed in 1 of 2 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 2 chance that participants will be assigned to placebo. All participants in Part 2 will receive linaclotide. Approximately 100 participants aged 2 to 5 years with FC will be enrolled in this study at around 45 sites worldwide.
Participants will receive daily doses of oral Linaclotide capsules or matching placebo for 12 weeks in Part 1 of the study. In Part 2, the open label long-term safety extension, participants with FC who completed study intervention in Part 1 of Study M21-572 or the Phase 2 Study LIN-MD-67 will receive linaclotide for 24 weeks.
REC name
North West - Haydock Research Ethics Committee
REC reference
23/NW/0140
Date of REC Opinion
8 Sep 2023
REC opinion
Further Information Favourable Opinion