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NCT04759833 · ClinicalTrials.gov registry record · Phase 3
A Study of Prucalopride For Functional Constipation in Children and Teenagers
A Phase 3 study, sponsored by Takeda.
- Terminated
- Registry status
- Phase 3
- Development phase
- 175
- Enrollment target
NCT04759833: Clinical Trial Phase 3 study, sponsored by Takeda.
NCT04759833 is a Phase 3 study that was terminated before completion, run by Takeda. The registered enrollment target is 175 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04759833, a Phase 3 study, was terminated before completion, sponsored by Takeda.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 175 participants
- Enrollment target
Study Summary
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.
Primary Outcome
Spontaneous bowel movement was defined as a bowel movement that was not preceded within a period of 24 hours by the intake of rescue medication. The average change from baseline in number of SBMs per week derived from the (e-diary) data, in toilet-trained participants who were at least 3 years of age collected during the placebo-controlled part (Part A) was assessed.
Interventions
- OTHER Placebo
- DRUG Prucalopride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 175 participants |
| Start Date | 2021-07-13 |
| Est. Completion | 2023-11-13 |
| Phase | Phase 3 |
Why NCT04759833 stopped before completion
NCT04759833 is an interventional study that assigns participants to a tested intervention. The registered 175 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04759833 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04759833 about?
NCT04759833 is a clinical study titled "A Study of Prucalopride For Functional Constipation in Children and Teenagers". 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 ...
What is the current status of trial NCT04759833?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 175 participants. The study started on 2021-07-13. Estimated completion is 2023-11-13.
What interventions are being tested in trial NCT04759833?
The interventions under investigation include: Placebo (OTHER), Prucalopride (DRUG).
Who is sponsoring clinical trial NCT04759833?
This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04759833's enrollment target sits among peer trials
175 1440th of 2000 higher than 559 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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