This is a Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-group Study of the Efficacy and Safety of 2 Weight-based Treatment Groups of Plecanatide Versus Placebo in Children and Adolescent Participants 6 to Less Than 18 Years of Age With FC

Running, not enrolling · Phase 2 · Has a placebo group

Conditions studied: Functional Constipation (FC)

In brief

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: * Does plecanatide increase the number of spontaneous bowel movements compared to placebo after 8 weeks of treatment? * What medical problems do participants experience when taking plecanatide? Researchers will compare low-dose plecanatide and high-dose plecanatide to placebo to see if plecanatide improves bowel movement frequency, stool consistency, and constipation-related symptoms. Participants will: * Complete a screening period with daily electronic diary entries to record bowel movements, symptoms, and rescue medication use * Take plecanatide or placebo by mouth once daily for 8 weeks * Continue daily electronic diary entries throughout the study * Attend clinic visits for physical exams, laboratory tests, and assessments of symptoms and safety * Provide blood samples for pharmacokinetic and safety evaluations * Complete questionnaires about constipation symptoms and quality of life

Key facts

Study ID

NCT07723924

Run by

Bausch Health Americas, Inc.

People needed

180

Starts

2026-06-01

Expected to finish

2027-10-18

Last updated by the study team

2026-07-23

Who can join

Age: 6 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Weight <15 kg at screening/randomization.
• History of anorectal malformations, neurological deficits, or anatomical abnormalities affecting bowel function.
• Use of prohibited medications within 15 days prior to randomization (e.g., anticholinergics, 5-HT agents, opioids, other laxatives).
• Use of any laxatives other than study-provided Dulcolax®.
• Pregnant or breastfeeding participants.
• Active eating disorder within the past 6 months.
• Clinically significant medical conditions (hepatic, renal, gastrointestinal, endocrine, infectious) that may interfere with study.
• Known hypersensitivity to plecanatide.
• History of drug or alcohol abuse within 12 months.
• Participation in another clinical trial within 30 days.
• Non-compliance with eDiary requirements (<5/7 entries per week).
• Use of rescue medication more than 2 days per week during baseline.
• ≥3 spontaneous bowel movements (SBMs) per week during baseline.

Where it is running

• AppleMedical Research Group, Inc — Miami, Florida, United States

Full record on ClinicalTrials.gov

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