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Can a Once-Daily pill ease chronic constipation in kids?

NCT ID NCT07723924

Symptom relief Sponsor: Bausch Health Americas, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 23, 2026 · Last updated Jul 24, 2026 · Updated 1 time

Summary

This trial tests whether plecanatide, a drug taken by mouth once a day, can safely improve bowel movements in children and adolescents aged 6 to 17 with functional constipation. Participants receive either low-dose plecanatide, high-dose plecanatide, or a placebo for 8 weeks. The study tracks changes in weekly spontaneous bowel movements and monitors for side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
plecanatide
What this could lead to
If it works, this could offer a new, once-daily treatment option for children with chronic constipation.
What could go wrong
This is a mid-stage trial with only 180 participants, so results may not apply to all children. Side effects are possible, and the drug may not work better than placebo.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 180 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2026

Expected to finish

Oct 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

6 to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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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Conditions

The condition(s) this trial relates to.

constipation disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Functional constipation (FC)

Contacts and locations

Locations

  • AppleMedical Research Group, Inc

    Miami, Florida, 33126, United States

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