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NCT07723924
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)
Sex: All
Ages: 6 Years – 17 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 180
Sponsor: Bausch Health Americas, Inc.
Location: AppleMedical Research Group, Inc Miami Florida
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 Criteria
Inclusion Criteria:• Male or female children and adolescents aged 6 to \
Source: ClinicalTrials.gov (NCT07723924). StuddyBuddy aggregates publicly available trial information.