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Last Updated: November 22, 2024

CLINICAL TRIALS PROFILE FOR PRUCALOPRIDE SUCCINATE


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All Clinical Trials for PRUCALOPRIDE SUCCINATE

Trial ID Title Status Sponsor Phase Start Date Summary
NCT01807000 ↗ Absorption, Metabolism and Excretion (AME) of Single Dose Radiolabeled Prucalopride Succinate in Volunteers Completed Shire Phase 1 2013-03-18 Phase I study to evaluate the excretion of radioactivity, the metabolic profile, pharmacokinetics, safety and tolerability following a single oral administration of [14C] Prucalopride Succinate in healthy male volunteers aged 18 to 50 years (inclusive).The purpose of this study is to investigate how and how quickly Prucalopride Succinate or its break down products are excreted by analysing blood, faeces and urine samples collected during the study.
NCT04759833 ↗ A Study of Prucalopride For Functional Constipation in Children and Teenagers Recruiting Takeda Development Center Americas, Inc. Phase 3 2021-08-02 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.
NCT04759833 ↗ A Study of Prucalopride For Functional Constipation in Children and Teenagers Recruiting Takeda Phase 3 2021-08-02 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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for PRUCALOPRIDE SUCCINATE

Condition Name

Condition Name for PRUCALOPRIDE SUCCINATE
Intervention Trials
Functional Constipation 1
Healthy 1
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Condition MeSH

Condition MeSH for PRUCALOPRIDE SUCCINATE
Intervention Trials
Constipation 1
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Clinical Trial Locations for PRUCALOPRIDE SUCCINATE

Trials by Country

Trials by Country for PRUCALOPRIDE SUCCINATE
Location Trials
United States 7
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Trials by US State

Trials by US State for PRUCALOPRIDE SUCCINATE
Location Trials
Tennessee 1
Oregon 1
Florida 1
California 1
Arizona 1
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Clinical Trial Progress for PRUCALOPRIDE SUCCINATE

Clinical Trial Phase

Clinical Trial Phase for PRUCALOPRIDE SUCCINATE
Clinical Trial Phase Trials
Phase 3 1
Phase 1 1
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Clinical Trial Status

Clinical Trial Status for PRUCALOPRIDE SUCCINATE
Clinical Trial Phase Trials
Completed 1
Recruiting 1
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Clinical Trial Sponsors for PRUCALOPRIDE SUCCINATE

Sponsor Name

Sponsor Name for PRUCALOPRIDE SUCCINATE
Sponsor Trials
Shire 1
Takeda Development Center Americas, Inc. 1
Takeda 1
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Sponsor Type

Sponsor Type for PRUCALOPRIDE SUCCINATE
Sponsor Trials
Industry 3
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