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
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.
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®.
Parallel
plecanatide
DrugPlecanatide 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
DrugPlacebo 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.
Change From Baseline in Weekly Spontaneous Bowel Movement (SBM) Frequency at Week 8
Spontaneous bowel movements (SBMs) are defined as bowel movements that occur without the use of rescue medication within the preceding 24 hours. Weekly SBM frequency will be calculated based on daily electronic diary entries. The endpoint is the change from baseline in the number of SBMs per week at Week 8.
Proportion of Participants Who Are SBM Responders at Week 8
An SBM responder is defined as a participant who achieves an increase from baseline of ≥1 spontaneous bowel movement (SBM) per week. The proportion of responders will be assessed at Week 8 based on electronic diary data.
Change From Baseline in Weekly Complete Spontaneous Bowel Movement (CSBM) Frequency at Week 8
Complete spontaneous bowel movements (CSBMs) are defined as SBMs associated with a sensation of complete evacuation. Weekly CSBM frequency will be calculated based on daily electronic diary entries. The endpoint is the change from baseline in the number of CSBMs per week at Week 8.
Change From Baseline in Stool Consistency as Measured by the Bristol Stool Form Scale (BSFS) at Week 8
Stool consistency will be assessed using the Bristol Stool Form Scale (BSFS) recorded in the electronic diary. Scores range from 1 (hard stools) to 7 (watery stools). The endpoint is the change from baseline in mean BSFS score at Week 8.
Time to First Spontaneous Bowel Movement (SBM)
Time to first spontaneous bowel movement (SBM) is defined as the time from first dose of study drug to the first SBM recorded in the electronic diary.
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