A Study of Prucalopride For Functional Constipation in Children and Teenagers
Public ClinicalTrials.gov record NCT04759833. 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
Phase 3, Multicenter, Randomized Study With 2 Different Doses of Prucalopride Administered to Male and Female Pediatric Subjects Aged 6 Months to 17 Years With Functional Constipation, Consisting of a 12-week Double-blind, Placebo-controlled Part (Part A) to Evaluate Efficacy and Safety Followed by a 36-week Double-blind Extension Part (Part B) to Document Long-term Safety up to Week 48
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Functional constipation is a condition when it is very hard to pass a stool that is not due to any other health problem or to medicines being taken. This condition is more common in children and teenagers. This study has 2 parts: The main aim of the 1st part of the study is to learn if a medicine called prucalopride can improve bowel movements in children and teenagers with functional constipation. Another aim is to check for side effects from 2 different doses of prucalopride. The main aim of the 2nd part of the study is to continue to check for side effects from 2 different doses of prucalopride. In the 1st part, at the first visit, the study doctor will check who can take part. Participants who take part will be picked for 1 of 3 treatments by chance. * A low dose of prucalopride once a day. * A higher dose of prucalopride once a day. * A placebo once a day. In this study, a placebo will look like prucalopride but will not have any medicine in it. Participants will be treated with prucalopride or a placebo for 12 weeks. Participants who took prucalopride will continue to the 2nd part of the study. They will have the same treatment as they did in the 1st part of the study. They will continue with their treatment for another 36 weeks. Participants who took placebo in the 1st part of the study will receive prucalopride in the 2nd part of the study. They will be picked for a low dose or a high dose of prucalopride by chance. Participants will visit the clinic a few times during treatment. The clinic staff will also telephone the participants, or their parents or caregivers throughout treatment for a check-up 4 weeks after last treatment, the clinic staff will telephone the participants, or their parents or caregivers for a final check-up.
Study identification
- NCT ID
- NCT04759833
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 175 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 6 Months 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
- Jul 13, 2021 (Actual)
- Primary completion
- Nov 13, 2023 (Actual)
- Completion
- Nov 13, 2023 (Actual)
- Last update posted
- Jun 6, 2024
2021 – 2023
United States locations
- U.S. sites
- 41
- U.S. states
- 19
- U.S. cities
- 35
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Phoenix Children's Hospital | Phoenix | Arizona | 85016 | — |
| Novak Clinical Research | Tucson | Arizona | 85741 | — |
| Eclipse Clinical Research | Tucson | Arizona | 85745 | — |
| Advanced Research Center, Inc. | Anaheim | California | 92805 | — |
| Children's Hospital of Orange County | Orange | California | 92868 | — |
| University of California, Davis Department of Pediatrics | Sacramento | California | 95817 | — |
| University of California | San Francisco | California | 94158 | — |
| University of Colorado Denver | Aurora | Colorado | 80045 | — |
| Medstar Georgetown University Hospital | Washington D.C. | District of Columbia | 20016 | — |
| Direct Helpers Research Center | Hialeah | Florida | 33012 | — |
| Pediatric & Adult Research Center | Kissimmee | Florida | 34741 | — |
| Auzmer Research | Lakeland | Florida | 33813 | — |
| University of Miami - Miller School of Medicine | Miami | Florida | 33136 | — |
| Nicklaus Children's Hospital | Miami | Florida | 33155 | — |
| Florida Research Center, Inc. | Miami | Florida | 33174 | — |
| Orlando Health - APH Center for Digestive Health and Nutrition | Orlando | Florida | 32806 | — |
| The University of Chicago Medical Center | Chicago | Illinois | 60637 | — |
| GI Pediatric Subspecialty Clinic | Peoria | Illinois | 61603 | — |
| Methodist Medical Center of Illinois | Peoria | Illinois | 61636 | — |
| Riley Hospital for Children at Indiana University Health | Indianapolis | Indiana | 46202 | — |
| Willis-Knighton Center for Pediatric Gastroenterology & Advanced Endoscopy | Shreveport | Louisiana | 71118 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| Boston Children's Hospital | Boston | Massachusetts | 02115 | — |
| Baystate Health | Springfield | Massachusetts | 01199 | — |
| Cardinal Glennon Children's Medical Center | St Louis | Missouri | 63104 | — |
| Jersey Shore University Medical Center | Neptune City | New Jersey | 07753 | — |
| CUMC Pediatrics-GI | New York | New York | 10032 | — |
| Cleveland Clinic | Cleveland | Ohio | 44195 | — |
| Cyn3rgy Research & Development | Gresham | Oregon | 97030 | — |
| Oregon Health & Science University | Portland | Oregon | 97239 | — |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | — |
| GI For Kids | Knoxville | Tennessee | 37922 | — |
| Le Bonheur Children's Hospital | Memphis | Tennessee | 38105 | — |
| Tekton Research, Inc. | Beaumont | Texas | 77706 | — |
| Cedar Health Research | Dallas | Texas | 75251 | — |
| Allure Health LLC | Friendswood | Texas | 77546 | — |
| Texas Children's Hospital | Houston | Texas | 77030 | — |
| Pediatric Associates | Houston | Texas | 77087 | — |
| Pediatric Center | Richmond | Texas | 77469 | — |
| University of Utah | Salt Lake City | Utah | 84108 | — |
| Pediatric Specialist of Virginia | Fairfax | Virginia | 22031 | — |
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 NCT04759833, 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 Jun 6, 2024 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04759833 live on ClinicalTrials.gov.