M21-862: Linaclotide for Functional Constipation (FC) in Pediatric Subjects, Ages 6months to 2 Years
Research type
Research Study
Full title
A Phase 2 Dose Finding Study Evaluating the Safety and Efficacy of Linaclotide in Pediatric Subjects 6 Months to Less Than 2 Years of Age with Functional Constipation (FC).
IRAS ID
1007442
Contact name
Alice Butler
Contact email
Sponsor organisation
AbbVie Deutschland GmbH & Co. KG
Eudract number
2022-501947-34
ISRCTN Number
N/A
Clinicaltrials.gov Identifier
N/A
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 pediatric patients who meet modified Rome IV criteria for childhood FC. In Part 1 of this study, participants are placed in 3 groups, which occur consecutively. Each group receives a different dosage of
linaclotide. In Part 2 of the study, participants will be randomly assigned to receive either linaclotide or placebo. There is a 1 in 2 chance that participants will be assigned to placebo. Approximately 30 pediatric participants 6 months to less than 2 years of age with FC will be enrolled in the study at about 25 sites worldwide.Participants will receive oral solution of linaclotide prepared from capsule by parent/guardian once daily for 4 weeks.
REC name
London - Brent Research Ethics Committee
REC reference
23/LO/0560
Date of REC Opinion
13 Sep 2023
REC opinion
Further Information Favourable Opinion