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

Condition(s) studied

Investigational drug(s) / intervention(s)

plecanatide: 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: 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 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

Eligibility

Primary outcome measure(s)

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

Trial sites (29)

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