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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

RecruitingPhase 2Ages 6 Years - 17 YearsAllBausch Health Americas, Inc.
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In plain words

What the trial is, and whether it could suit you

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 dai

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📋 Eligibility rules (as published)
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 effective contraception and have negative pregnancy tests. Exclusion Criteria: * 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.
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What it tests

  • plecanatide
  • Placebo
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Where

29 sites
University of Alabama at Birmingham/Children's of Alabama
Birmingham, United States
The Center for Clinical Trials, Inc.
Mobile, United States
The Center for Clinical Trials, Inc.
Saraland, United States
HealthStar Research, LLC
Hot Springs, United States
Applied Research Center of Arkansas
Little Rock, United States
Advanced Research Center, Inc.
Anaheim, United States
Sun Valley Research Center
Imperial, United States
Center for Clinical Trials, LLC
Paramount, United States

…and 21 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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