Ignite Creation Date:
2024-05-06 @ 3:47 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04759833
Status:
TERMINATED
Last Update Posted:
2024-06-06
First Post:
2021-02-16
Brief Title:
A Study of Prucalopride For Functional Constipation in Children and Teenagers
Sponsor:
Takeda
Organization:
Takeda
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Data Monitoring Committee DMC decision terminated due to futility with no safety concerns FDA agreement to terminate the study
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
This study consists of a 12-week double-blind placebo-controlled part Part A followed by a 36-week double-blind safety extension part Part B Participants aged 3 to 17 years are planned for randomization in a 111 ratio to the Low Dose Group High Dose Group or matching placebo placebo-controlled part Part A After completion of Part A participants in the placebo group will be re-randomized in a 11 ratio to the Low Dose Group or the High Dose Group safety extension part Part B Randomization at study entry will be stratified by toilet-trained status
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2022-003221-22 | EUDRACT_NUMBER | None | None |