Long-term Safety of Linaclotide in Paed Participants with FC or IBS-C
Research type
Research Study
Full title
A Phase 3, Open-label, Long-term Safety Study of Oral Linaclotide Administered to Pediatric Participants with Functional Constipation (FC) or Irritable Bowel Syndrome with Constipation (IBS-C)
IRAS ID
275489
Contact name
Andrea Sawdon
Contact email
Sponsor organisation
Allergan Limited
Eudract number
2019-001955-38
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
63,290, IND
Duration of Study in the UK
1 years, 7 months, 10 days
Research summary
Functional constipation is a common problem in children of all ages worldwide. Symptoms include irregular, hard stools, and painful bowel movements, and affected children may have stomach pain and faecal incontinence, which is usually the result of large amounts of stool becoming stuck in the colon or rectum leading to overflow incontinence. These symptoms can have a severe impact on a child’s quality of life and may lead to participants missing school and large costs related to healthcare use.
This is a Phase 3 open-label study with 24 weeks Functional Constipation (FC participants) of linaclotide exposure that will enrol paediatric participants (6-17 years of age) with FC who completed study intervention in Study LIN-MD-64 based on the individual study criteria. It will include a screening period and an open-label study intervention period.
At least 120 participants are planned to be enrolled globally to receive open-label linaclotide study intervention which means the study doctor and participants will know which drug they are using. However, the actual number of participants in this study will depend on the number of participants who have completed study intervention in the lead-in study (LIN-MD-64) and enrol into this open-label study after fulfilling the eligibility criteria.
Up to 120 sites from the United States, Canada, and Europe and the Middle East will have an option to participate in the study. The study is sponsored by Allergan Ltd.
REC name
West of Scotland REC 1
REC reference
21/WS/0040
Date of REC Opinion
8 Jun 2021
REC opinion
Further Information Favourable Opinion