This is a Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-group Study of the … (NCT07723924) | Clinical Trial Compass
Active — Not RecruitingPhase 2
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
United States180 participantsStarted 2026-06-01
Plain-language 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
Who can participate
Age range
6 Years – 17 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 medi…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change From Baseline in Weekly Spontaneous Bowel Movement (SBM) Frequency at Week 8