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
Study identification
- NCT ID
- NCT04759833
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Takeda
- Industry
- Enrollment
- 175 participants
Conditions and interventions
Conditions
Interventions
- Prucalopride Drug
- Placebo Other
Drug · Other
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 12, 2021
- Primary completion
- Nov 12, 2023
- Completion
- Nov 12, 2023
- Last update posted
- Jun 5, 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 5, 2024 · Synced Jul 21, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04759833 live on ClinicalTrials.gov.