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
Bausch Health Americas, Inc. · NCT07723924
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 6–17 · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Phase 2
- Target enrollment
- 180
- US sites recruiting
- 23
- Study start
- August 18, 2026
- Record last updated
- October 7, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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
Being studied: plecanatide; Placebo
Conditions: Functional Constipation (FC)
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
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.
Recruiting US locations
The Center for Clinical Trials, Inc.
Mobile, AL 36609
Site contact: Primary Coordinator · 251-341-7021 · Ranya@thecenterforclinicaltrials.com
The Center for Clinical Trials, Inc.
Saraland, AL 36571
Site contact: Primary Coordinator · 251-341-7021 · Joann@thecenterforclinicaltrials.com
HealthStar Research, LLC
Hot Springs, AR 71913
Site contact: Primary Coordinator · 501-760-2903 · mlawson@healthstaresearch.com
Applied Research Center of Arkansas
Little Rock, AR 72205
Site contact: Primary Coordinator · 501-954-7822 · Rhonda@arcarkansas.com
Advanced Research Center, Inc.
Anaheim, CA 92805
Site contact: Primary Coordinator · 714-999-6688 · Hnguyen@arctrials.com
Center for Clinical Trials, LLC
Paramount, CA 90723
Site contact: Primary Coordinator · 562-633-5101 · Chua9152@aol.com
Direct Helpers Research Center
Hialeah, FL 33012
Site contact: Primary Coordinator · 305-828-3555 · Francis@dhrtrials.com
AppleMedical Research Group, Inc
Miami, FL 33126
Site contact: Primary Coordinator · 305-667-8434 · C26applemed@aol.com
SouthCoast Research Center, Inc.
Miami, FL 33136
Site contact: Primary Coordinator · 786-332-2721 · sc6@southresearch.org
Rophe Adult and Pediatric Medicine/SKYCRNG
Union City, GA 30291
Site contact: Primary Coordinator · 888-659-4363 · nicole.williams@skycrng.com
AMR Clinical
El Dorado, KS 67042
Site contact: Primary Coordinator · 316-600-5127 · deijah.poore@amr-clinical.com
AMR Clinical
Wichita, KS 67226
Site contact: Primary Coordinator · 316-689-6635 · Brandon.sommers@amr-clinical.com
Willis Knighton Clinical Research
Shreveport, LA 71105
Site contact: Primary Coordinator · 318-212-2863 · sstephens2@wkhs.com
PriMED Clinical Research
Dayton, OH 45429
Site contact: Primary Coordinator · 937-534-4201 · Eva.collins@primedphysicians.com
Cyn3rgy Research
Gresham, OR 97030
Site contact: Primary Coordinator · 503-907-2179 · dfranzen@cyn3rgy.com
Frontier Clinical Research, LLC
Scottdale, PA 15683
Site contact: Primary Coordinator · 724-220-5281 · alauffer@frontierclinical.com
Frontier Clinical Research, LLC
Smithfield, PA 15478
Site contact: Primary Coordinator · 724-569-8036 · Jblack@frontierclinical.com
Carolina Family Care
Charleston, SC 29414
Site contact: Primary Coordinator · 843-870-2225 · Thommatt@musc.edu
Austin Regional Clinic
Austin, TX 78726
Site contact: Primary Coordinator · 737-247-7240 · Jbeanblossom@innovoresearch.com
Sun Research Institute
San Antonio, TX 78215
Site contact: Primary Coordinator · 210-227-1289 · bparthiban@sunresearch.com
ClinPoint Trials, LLC
Waxahachie, TX 75165
Site contact: Primary Coordinator · 972-937-1640 · Lcrisp@cptrials.com
Pediatric Research of Charlottesville, LLC
Charlottesville, VA 22902
Site contact: Primary Coordinator · 434-872-9384 · Catherine@proc211.com
Frontier Clinical Research, LLC
Kingwood, WV 26537
Site contact: Primary Coordinator · 304-441-2006 · Cappleton@frontierclinical.com
Study contacts (from the official record)
- Angela Moore, Director · 843-877-2756 · angela.moore@bauschhealth.com
- Wendy Walton, BSN · 505-917-8552 · wendy.walton@bauschhealth.com