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
Public ClinicalTrials.gov record NCT07723924. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 2b, Randomized, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy and Safety of Plecanatide in Children and Adolescents Age 6 to <18 Years of Age With Functional Constipation (FC)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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
Study identification
- NCT ID
- NCT07723924
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 180 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 6 Years to 17 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 18, 2026 (Actual)
- Primary completion
- Oct 18, 2027 (Estimated)
- Completion
- Oct 18, 2027 (Estimated)
- Last update posted
- Oct 7, 2026
2026 – 2027
United States locations
- U.S. sites
- 29
- U.S. states
- 16
- U.S. cities
- 28
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham/Children's of Alabama | Birmingham | Alabama | 35233 | Not yet recruiting |
| The Center for Clinical Trials, Inc. | Mobile | Alabama | 36609 | Recruiting |
| The Center for Clinical Trials, Inc. | Saraland | Alabama | 36571 | Recruiting |
| HealthStar Research, LLC | Hot Springs | Arkansas | 71913 | Recruiting |
| Applied Research Center of Arkansas | Little Rock | Arkansas | 72205 | Recruiting |
| Advanced Research Center, Inc. | Anaheim | California | 92805 | Recruiting |
| Sun Valley Research Center | Imperial | California | 92251 | Not yet recruiting |
| Center for Clinical Trials, LLC | Paramount | California | 90723 | Recruiting |
| Loma Linda University | San Bernardino | California | 92408 | Not yet recruiting |
| Direct Helpers Research Center | Hialeah | Florida | 33012 | Recruiting |
| AppleMedical Research Group, Inc | Miami | Florida | 33126 | Recruiting |
| SouthCoast Research Center, Inc. | Miami | Florida | 33136 | Recruiting |
| Rophe Adult and Pediatric Medicine/SKYCRNG | Union City | Georgia | 30291 | Recruiting |
| AMR Clinical | El Dorado | Kansas | 67042 | Recruiting |
| AMR Clinical | Wichita | Kansas | 67226 | Recruiting |
| Willis Knighton Clinical Research | Shreveport | Louisiana | 71105 | Recruiting |
| University of Maryland Baltimore | Baltimore | Maryland | 21201 | Not yet recruiting |
| Boys Town National Research Hospital | Boys Town | Nebraska | 68010 | Not yet recruiting |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | Not yet recruiting |
| PriMED Clinical Research | Dayton | Ohio | 45429 | Recruiting |
| Cyn3rgy Research | Gresham | Oregon | 97030 | Recruiting |
| Frontier Clinical Research, LLC | Scottdale | Pennsylvania | 15683 | Recruiting |
| Frontier Clinical Research, LLC | Smithfield | Pennsylvania | 15478 | Recruiting |
| Carolina Family Care | Charleston | South Carolina | 29414 | Recruiting |
| Austin Regional Clinic | Austin | Texas | 78726 | Recruiting |
| Sun Research Institute | San Antonio | Texas | 78215 | Recruiting |
| ClinPoint Trials, LLC | Waxahachie | Texas | 75165 | Recruiting |
| Pediatric Research of Charlottesville, LLC | Charlottesville | Virginia | 22902 | Recruiting |
| Frontier Clinical Research, LLC | Kingwood | West Virginia | 26537 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07723924, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 7, 2026 · Synced Oct 22, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT07723924 live on ClinicalTrials.gov.