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

Conditions

• Functional Constipation (FC)

Eligibility Criteria

Sex

ALL

Age

6 Years - 17 Years

Healthy Volunteers

Not accepted

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.
• 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.

Study Details

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 Dates

First listed

Jul 23, 2026

Start date

Jun 1, 2026

Status verified

Jul 2026

Primary completion

Oct 18, 2027

Completion

Oct 18, 2027

Study Design

Enrollment

180 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Low Dose Plecanatide
  Participants will receive weight-based low-dose plecanatide administered orally once daily for 8 weeks.
• Experimental: High Dose Plecanatide
  Participants will receive weight-based high-dose plecanatide orally once daily for 8 weeks.
• Placebo Comparator: Placebo
  Participants will receive matching placebo orally once daily for 8 weeks.

Primary Outcome Measure

Change From Baseline in Weekly Spontaneous Bowel Movement (SBM) Frequency at Week 8 [ Time Frame: Baseline to week 8 ]

Locations (1)

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