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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

A Phase 2b, Randomized, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy and Safety of Plecanatide in Children and Adolescents Age 6 to <18 Years of Age With Functional Constipation (FC)

Who can join

Ages 6 to 17 · All sexes

Inclusion Criteria:• Male or female children and adolescents aged 6 to \<18 years at time of consent.

* Diagnosis of functional constipation (FC) based on Rome IV criteria for children/adolescents.
* Participant and/or legally authorized representative able to provide informed consent/assent.
* Participant/caregiver willing and able to comply with study procedures, including electronic diary (eDiary).
* Completion of ≥5 out of 7 daily diary entries during each of the 2 baseline weeks.
* Stable diet for at least 14 days prior to screening.
* Females of childbearing potential must use highly effective contraception and have negative pregnancy tests.

Exclusion Criteria:

* 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.

About the study

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

What is being tested

• plecanatide (drug)
• Placebo (drug)

Sponsor: Bausch Health Americas, Inc. · Participants: 180 · Started: Aug 18, 2026

Contact the study team

• Angela Moore, Director · Phone: 843-877-2756
• Wendy Walton, BSN · Phone: 505-917-8552

Official record on ClinicalTrials.gov — NCT07723924

Locations in the U.S.

Conditions

• Constipation

From ClinicalTrials.gov, data retrieved Oct 4, 2026. Each study sets its own eligibility; the study team decides who can join.