A Study to Assess Adverse Events and Change in Disease Activity in Pediatric Participants (Age 6 Months to 2 Years) With Functional Constipation Who Are Treated With Linaclotide - Trial NCT05760313
Access comprehensive clinical trial information for NCT05760313 through Pure Global AI's free database. This Phase 2 trial is sponsored by AbbVie and is currently Recruiting. The study focuses on Functional Constipation. Target enrollment is 30 participants.
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Study Focus
Sponsor & Location
AbbVie
Timeline & Enrollment
Phase 2
Apr 27, 2023
Dec 20, 2024
Primary Outcome
Change from baseline in overall Spontaneous Bowel Movement (SBM) frequency rate (SBMs/week) during the Study Intervention Period,Change from baseline in stool consistency (Bristol Stool Form Scale) during the Study Intervention Period,Change from baseline in straining during the Study Intervention Period,Number of Participants with Adverse Events (AEs)
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.
 
 There may be higher treatment burden for participants in this trial compared to their
 standard of care (due to study procedures). Participants will attend regular visits during
 the study at a hospital or clinic. The effect of the treatment will be checked by medical
 assessments, blood tests, checking for side effects and completing questionnaires.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT05760313
Non-Device Trial