Ignite Creation Date:
2024-05-06 @ 4:00 PM
Last Modification Date:
2024-10-26 @ 2:01 PM
Study NCT ID:
NCT04838522
Status:
RECRUITING
Last Update Posted:
2024-06-28
First Post:
2021-03-25
Brief Title:
A Study of Prucalopride in Breastfeeding Women With Constipation
Sponsor:
Takeda
Organization:
Takeda
Study Overview
Official Title:
A Breast Milk Study in Lactating Women Who Have Been Prescribed Therapeutic Doses of MOTEGRITY or RESOTRAN Prucalopride for Chronic Idiopathic Constipation to Evaluate Prucalopride Concentrations in Breast Milk and to Collect Incidental Safety Data From the Nursing Infants
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Prucalopride is a medicine used to treat constipation The main aim of the study is to measure prucalopride concentrations in breast milk Other aims are to check the growth and development of babies breastfed by their mothers who took prucalopride and to check if the babies had any side effects
During the study participants will provide one set of milk samples over 24 hours using an electric breast pump Breast milk samples will be collected at home and will be shipped to the laboratory
Also participants will be asked questions during telephone interviews every 2 months in the first year of their babys life They will also be asked to complete growth and development questionnaires about their baby
During the study participants will provide one set of milk samples over 24 hours using an electric breast pump Breast milk samples will be collected at home and will be shipped to the laboratory
Also participants will be asked questions during telephone interviews every 2 months in the first year of their babys life They will also be asked to complete growth and development questionnaires about their baby
Detailed Description:
None
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 |
|---|---|---|---|
| EUPAS40105 | OTHER | EU PAS Register Number | None |