NCT07723924 · Bausch Health Americas, Inc.
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
(Trulance)
What this 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 how the drug moves through the body of plecanatide in this population.
View original scientific description
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.
Interventions
DRUG
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.
DRUG
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 measures
Change From Baseline in Weekly Spontaneous Bowel Movement (SBM) Frequency at Week 8
Time frame: Baseline to 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Birmingham, Alabama
- Mobile, Alabama
- Saraland, Alabama
- Hot Springs, Arkansas
- Little Rock, Arkansas
- Anaheim, California
- Imperial, California
- Paramount, California
- San Bernardino, California
- Hialeah, Florida
- Miami, Florida
- Union City, Georgia
And 16 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 2, 2026 · Source of record for eligibility and locations