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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 is a Phase 3 study that was terminated before completion, run by Takeda. The registered enrollment target is 175 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04759833
The ClinicalTrials.gov registry entry for NCT04759833 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 175 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Takeda, which has 408 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04759833 reports 0 study locations.
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.
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