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

NCT07723924 | Active Not Recruiting Phase 2 FDA Drug

• 1 other identifier: SP304202-07
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Functional Constipation (FC)

Keywords

constipation; pediatric; functional constipation; chronic idiopathic constipation; children; plecanatide; trulance; FC; CIC; chronic constipation

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Weekly Spontaneous Bowel Movement (SBM) Frequency at Week 8

  Spontaneous bowel movements (SBMs) are defined as bowel movements that occur without the use of rescue medication within the preceding 24 hours. Weekly SBM frequency will be calculated based on daily electronic diary entries. The endpoint is the change from baseline in the number of SBMs per week at Week 8.

  Baseline to week 8

Secondary Outcomes (6)

• Proportion of Participants Who Are SBM Responders at Week 8

  week 8

• Change From Baseline in Weekly Complete Spontaneous Bowel Movement (CSBM) Frequency at Week 8

  Baseline to week 8

• Change From Baseline in Stool Consistency as Measured by the Bristol Stool Form Scale (BSFS) at Week 8

  Baseline to week 8

• Time to First Spontaneous Bowel Movement (SBM)

  up to 8 weeks

• Use of Rescue Medication Over 8 Weeks

  Baseline and Weeks 1 through 8

Study Arms (3)

Low Dose Plecanatide

EXPERIMENTAL

Participants will receive weight-based low-dose plecanatide administered orally once daily for 8 weeks.

Drug: plecanatide

High Dose Plecanatide

EXPERIMENTAL

Participants will receive weight-based high-dose plecanatide orally once daily for 8 weeks.

Drug: plecanatide

Placebo

PLACEBO COMPARATOR

Participants will receive matching placebo orally once daily for 8 weeks.

Drug: Placebo

Interventions

plecanatide DRUG

Plecanatide is administered orally once daily for 8 weeks. Participants receive weight-based dosing corresponding to assigned treatment arm (low-dose or high-dose) to achieve target exposure ranges. Tablets may be taken with or without food and may be swallowed whole or administered in an alternative form if necessary, as specified in the protocol.

High Dose Plecanatide; Low Dose Plecanatide

Placebo DRUG

Placebo tablets matching plecanatide in appearance are administered orally once daily for 8 weeks. Placebo is used to maintain blinding and is administered under the same conditions as active study drug.

Placebo

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

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.

Sponsors & Collaborators

• Bausch Health Americas, Inc.: lead

Study Sites (1)

AppleMedical Research Group, Inc

Miami, Florida, 33126, United States

Location

MeSH Terms

Conditions

Constipation

Interventions

plecanatide

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants will be randomized in a 1:1:1 ratio to receive low-dose plecanatide, high-dose plecanatide, or placebo. Randomization will be stratified by age group (6 to 11 years and 12 to less than 18 years) and sex. Participants will receive once-daily oral study drug for 8 weeks based on weight-based dosing. The study uses a double-blind design in which participants, investigators, and study personnel are unaware of treatment assignment. Efficacy and safety will be evaluated through electronic diary assessments and scheduled study visits. Parallel treatment groups will be compared to assess differences between plecanatide dose groups and placebo.

Study Record Dates

• First Submitted: July 20, 2026
• First Posted: July 23, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): October 18, 2027
• Study Completion (Estimated): October 18, 2027
• Last Updated: July 23, 2026

Record last verified: 2026-07

Locations

US (1)