A Study of Prucalopride in Breastfeeding Women With Constipation
About this clinical trial
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 baby's life. They will also be asked to complete growth and development questionnaires about their baby.
At a glance
What medical conditions are being studied?
What is the clinical trial testing?
No Intervention
How many participants are being enrolled?
12
Are placebos part of the clinical trial?
No
When is the clinical trial being conducted?
Mar 2022 - Oct 2027
How long is participation in the clinical trial?
Each participant will be in the study for up to 16 months. All information is collected remotely, and the study is open to participants across the United States and Canada.
Key requirements
Sexes
Female
Age
18+ Years
Healthy volunteers?
No
Entry criteria
