Recruiting

Phase 2

PlecanatideThis 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

Sponsor:

Bausch Health Americas, Inc.

Code:

NCT07723924

Conditions

Functional Constipation (FC)

Eligibility Criteria

Sex: All

Age: 6 - 17

Healthy Volunteers: Not accepted

Interventions

plecanatide

Placebo

Study Details

Brief 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

Conditions

Functional Constipation (FC)

Study ID

NCT07723924

Start date

Aug 18, 2026

Status verified date

Sep, 2026

Completion date

Oct 18, 2027

Anticipated

Primary completion date

Oct 18, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 6 - 17

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

180 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

plecanatide

Plecanatide 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

Placebo 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.

Primary outcome measure

Change From Baseline in Weekly Spontaneous Bowel Movement (SBM) Frequency at Week 8 [ Time Frame: Baseline to week 8 ]

Central Contacts and Locations

Central contacts

Angela Moore, Director

843-877-2756 angela.moore@bauschhealth.com

Wendy Walton, BSN

505-917-8552 wendy.walton@bauschhealth.com

Locations

The Center for Clinical Trials, Inc.

Recruiting

Saraland, Alabama, United States, 36571

Contacts

Primary Coordinator

251-341-7021 Joann@thecenterforclinicaltrials.com

Principal Investigator:

Howard Rubenstein, MD

HealthStar Research, LLC

Recruiting

Hot Springs, Arkansas, United States, 71913

Contacts

Primary Coordinator

501-760-2903 mlawson@healthstaresearch.com

Principal Investigator:

Jon M. Robert, MD

Applied Research Center of Arkansas

Recruiting

Little Rock, Arkansas, United States, 72205

Contacts

Primary Coordinator

501-954-7822 Rhonda@arcarkansas.com

Principal Investigator:

Louis D. Velez, MD

Advanced Research Center, Inc.

Recruiting

Anaheim, California, United States, 92805

Contacts

Primary Coordinator

714-999-6688 Hnguyen@arctrials.com

Principal Investigator:

Rennan Quijano, MD

Center for Clinical Trials, LLC

Recruiting

Paramount, California, United States, 90723

Contacts

Primary Coordinator

562-633-5101 Chua9152@aol.com

Principal Investigator:

Liberation B. De Leon, MD

Direct Helpers Research Center

Recruiting

Hialeah, Florida, United States, 33012

Contacts

Primary Coordinator

305-828-3555 Francis@dhrtrials.com

Principal Investigator:

Manuel Sanchez, MD

AppleMedical Research Group, Inc

Recruiting

Miami, Florida, United States, 33126

Contacts

Primary Coordinator

305-667-8434 C26applemed@aol.com

Principal Investigator:

Agustin J. Latorre, MD

SouthCoast Research Center, Inc.

Recruiting

Miami, Florida, United States, 33136

Contacts

Primary Coordinator

786-332-2721 sc6@southresearch.org

Principal Investigator:

Adonis Maiquez, MD

Rophe Adult and Pediatric Medicine/SKYCRNG

Recruiting

Union City, Georgia, United States, 30291

Contacts

Primary Coordinator

888-659-4363 nicole.williams@skycrng.com

Principal Investigator:

Yvonne Smith, MD

AMR Clinical

Recruiting

El Dorado, Kansas, United States, 67042

Contacts

Primary Coordinator

316-600-5127 deijah.poore@amr-clinical.com

Principal Investigator:

Michael A. Rausch, MD

AMR Clinical

Recruiting

Wichita, Kansas, United States, 67226

Contacts

Primary Coordinator

316-689-6635 Brandon.sommers@amr-clinical.com

Principal Investigator:

Terry D. Klein, MD

Cyn3rgy Research

Recruiting

Gresham, Oregon, United States, 97030

Contacts

Primary Coordinator

503-907-2179 dfranzen@cyn3rgy.com

Principal Investigator:

Frank A. Calcagno, MD

Frontier Clinical Research, LLC

Recruiting

Scottdale, Pennsylvania, United States, 15683

Contacts

Primary Coordinator

724-220-5281 alauffer@frontierclinical.com

Principal Investigator:

Tiffany Pluto, DO

Frontier Clinical Research, LLC

Recruiting

Smithfield, Pennsylvania, United States, 15478

Contacts

Primary Coordinator

724-569-8036 Jblack@frontierclinical.com

Principal Investigator:

Marcy Goisse, MD

Sun Research Institute

Recruiting

San Antonio, Texas, United States, 78215

Contacts

Primary Coordinator

210-227-1289 bparthiban@sunresearch.com

Principal Investigator:

Leonel Reyes, Jr., MD

ClinPoint Trials, LLC

Recruiting

Waxahachie, Texas, United States, 75165

Contacts

Primary Coordinator

972-937-1640 Lcrisp@cptrials.com

Principal Investigator:

Peggy Linguist, MD

Pediatric Research of Charlottesville, LLC

Recruiting

Charlottesville, Virginia, United States, 22902

Contacts

Primary Coordinator

434-872-9384 Catherine@proc211.com

Principal Investigator:

Paul P. Wisman, Jr., MD

Frontier Clinical Research, LLC

Recruiting

Kingwood, West Virginia, United States, 26537

Contacts

Primary Coordinator

304-441-2006 Cappleton@frontierclinical.com

Principal Investigator:

Jeffry Pilney, MD

More Information

Sponsor

Bausch Health Americas, Inc.

Last update posted

Oct 2, 2026

Last verified

Sep, 2026

Keywords

constipation
pediatric
functional constipation
chronic idiopathic constipation
children
plecanatide
trulance
FC
CIC
chronic constipation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-03. This information was provided to ClinicalTrials.gov by Bausch Health Americas, Inc. on 2026-10-02. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.