The goal of this clinical trial is to learn if plecanatide can treat functional constipation in children and adolescents aged 6 to less than 18 years. It will also learn about the safety and pharmacokinetics of plecanatide in this population. The main questions it aims to answer are:
Participants will:
Inclusion Criteria:• Male or female children and adolescents aged 6 to <18 years at time of consent.
Exclusion Criteria:
This is a double-blind study in which participants, investigators, study site personnel, and outcome assessors are unaware of treatment assignments. Matching placebo tablets are identical in appearance to active study drug to maintain the blind. Randomization codes are generated and maintained by an interactive web-based randomization system. Treatment assignments will be unblinded only after database lock, unless unblinding is required for participant safety in a medical emergency.
Participants will receive weight-based low-dose plecanatide administered orally once daily for 8 weeks.
Participants will receive weight-based high-dose plecanatide orally once daily for 8 weeks.
Participants will receive matching placebo orally once daily for 8 weeks.
Miami, Florida 33126, United States
An Efficacy and Safety Study of Plecanatide in Adolescents 12 to <18 Years of Age With Chronic Idiopathic Constipation
Efficacy and Safety of Plecanatide in Children 6 to <18 Years With Irritable Bowel Syndrome With Constipation (IBS-C)
The Plecanatide Chronic Idiopathic Constipation (CIC) Study
Efficacy and Safety of Plecanatide Comparing With Placebo in the Treatment of Functional Constipation
12-Week Study of Plecanatide for CIC (The National CIC3 Study)
12-Week Study of Plecanatide for CIC (The CIC3 Study)
The Plecanatide Irritable Bowel Syndrome With Constipation Study (IBS-C)
Second Plecanatide Study In Irritable Bowel Syndrome With Constipation (IBS-C)