NCT04838522

A Study of Prucalopride in Breastfeeding Women With Constipation

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
• Phase: —
• Study type: Observational
• Enrollment: 12 (estimated)
• Sponsor: Takeda · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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 baby's life. They will also be asked to complete growth and development questionnaires about their baby.

Conditions

• Chronic Idiopathic Constipation (CIC)

Interventions

Type	Name	Description
OTHER	No Intervention	This is a non-interventional study.

Timeline

• Start date: 2022-03-02
• Primary completion: 2027-10-31
• Completion: 2027-10-31
• First posted: 2021-04-09
• Last updated: 2025-05-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study