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)
Bausch Health Americas, Inc.
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
Description
This Phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel-group study is designed to evaluate the efficacy, safety, and pharmacokinetics (PK) of plecanatide administered orally once daily in pediatric participants with functional constipation (FC). Approximately 180 participants will be enrolled at up to 30 investigational sites in the United States and randomized in a 1:1:1 ratio to receive low-dose plecanatide, high-dose plecanatide, or matching placebo. Randomization will be stratified by age group (6 to 11 years and 12 to less than 18 years) and sex. Background an…
Eligibility
- Age range
- 6–17 years
- Sex
- All
- Healthy volunteers
- No
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 ef…
Interventions
- Drugplecanatide
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.
- DrugPlacebo
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.
Locations (29)
- University of Alabama at Birmingham/Children's of AlabamaBirmingham, Alabama
- The Center for Clinical Trials, Inc.Mobile, Alabama
- The Center for Clinical Trials, Inc.Saraland, Alabama
- HealthStar Research, LLCHot Springs, Arkansas
- Applied Research Center of ArkansasLittle Rock, Arkansas
- Advanced Research Center, Inc.Anaheim, California