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

Short name Trulance

NCTNCT07723924Other idSP304202-07

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Overview

Status: Recruiting
Phase: Phase 2
Enrollment: 180 participants (estimated)
Sponsor: Bausch Health Americas, Inc. · Industry
Design: Randomized · Quadruple masking
Countries: 1 country
United States
Start: 18 Aug 2026
Primary completion: 18 Oct 2027 (estimated)
Completion: 18 Oct 2027 (estimated)
First posted: 23 Jul 2026
Last update posted: 7 Oct 2026
Conditions: Functional Constipation (FC)

Timeline

1 trial · 1 ongoing

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

202620272028

Ph 2
Trulance
NCT07723924
18 Aug 2026 to est. 18 Oct 2027

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

plecanatideDrug
PlaceboDrug

Arms3

Experimental
Low Dose Plecanatide
Participants will receive weight-based low-dose plecanatide administered orally once daily for 8 weeks.
Experimental
High Dose Plecanatide
Participants will receive weight-based high-dose plecanatide orally once daily for 8 weeks.
Placebo comparator
Placebo
Participants will receive matching placebo orally once daily for 8 weeks.

Primary outcomes1

Outcomes the sponsor listed as primary.

Change From Baseline in Weekly Spontaneous Bowel Movement (SBM) Frequency at Week 8
Time frame · Baseline to week 8
Registry description
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.

Secondary outcomes(6)

Proportion of Participants Who Are SBM Responders at Week 8
Time frame · week 8
Registry description
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
Time frame · Baseline to week 8
Registry description
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
Time frame · Baseline to week 8
Registry description
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 frame · up to 8 weeks
Registry description
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.
Use of Rescue Medication Over 8 Weeks
Time frame · Baseline and Weeks 1 through 8
Registry description
Rescue medication use is defined as the number of days participants use rescue medication (bisacodyl) due to lack of bowel movement. Use will be recorded daily in the electronic diary.
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Time frame · Up to 10 weeks
Registry description
A treatment-emergent adverse event (TEAE) is any adverse event that begins or worsens after the first dose of study drug through the end of the follow-up period.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 6 Years up to 17 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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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