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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
Sponsor: 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
Official title: 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)
Key Details
Gender
All
Age Range
6 Years - 17 Years
Study Type
INTERVENTIONAL
Enrollment
180
Start Date
2026-08-18
Completion Date
2027-10-18
Last Updated
2026-10-29
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (29)
University of Alabama at Birmingham/Children's of Alabama
Birmingham, Alabama, United States
The Center for Clinical Trials, Inc.
Mobile, Alabama, United States
The Center for Clinical Trials, Inc.
Saraland, Alabama, United States
HealthStar Research, LLC
Hot Springs, Arkansas, United States
Applied Research Center of Arkansas
Little Rock, Arkansas, United States
Advanced Research Center, Inc.
Anaheim, California, United States
Sun Valley Research Center
Imperial, California, United States
Center for Clinical Trials, LLC
Paramount, California, United States
Loma Linda University
San Bernardino, California, United States
Direct Helpers Research Center
Hialeah, Florida, United States
AppleMedical Research Group, Inc
Miami, Florida, United States
SouthCoast Research Center, Inc.
Miami, Florida, United States
Rophe Adult and Pediatric Medicine/SKYCRNG
Union City, Georgia, United States
AMR Clinical
El Dorado, Kansas, United States
AMR Clinical
Wichita, Kansas, United States
Willis Knighton Clinical Research
Shreveport, Louisiana, United States
University of Maryland Baltimore
Baltimore, Maryland, United States
Boys Town National Research Hospital
Boys Town, Nebraska, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
PriMED Clinical Research
Dayton, Ohio, United States
Cyn3rgy Research
Gresham, Oregon, United States
Frontier Clinical Research, LLC
Scottdale, Pennsylvania, United States
Frontier Clinical Research, LLC
Smithfield, Pennsylvania, United States
Carolina Family Care
Charleston, South Carolina, United States
Austin Regional Clinic
Austin, Texas, United States
Sun Research Institute
San Antonio, Texas, United States
ClinPoint Trials, LLC
Waxahachie, Texas, United States
Pediatric Research of Charlottesville, LLC
Charlottesville, Virginia, United States
Frontier Clinical Research, LLC
Kingwood, West Virginia, United States