A Study of Prucalopride in Breastfeeding Women With Constipation

Conditions

• Chronic Idiopathic Constipation (CIC)

Eligibility Criteria

Sex

FEMALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• No Intervention — OTHER
  This is a non-interventional study.

Study Details

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.

Key Dates

Start date

Mar 2, 2022

Status verified

Apr 2026

Primary completion

Oct 31, 2027

Completion

Oct 31, 2027

Study Design

Enrollment

12 participants (estimated)

Arms

• Arm: All Study Participants
  Participants with chronic idiopathic constipation who are treated with prucalopride oral tablets which was initiated prior to enrollment, and are breastfeeding their infant at the time of enrollment and sample collection will be observed prospectively.

Primary Outcome Measure

Dose- Normalized Area Under the Milk Concentration-time Curve of Prucalopride (AUC [milk, norm]) [ Time Frame: Pre-dose, 1, 2, 4, 8, 12, and 24 hours post-dose on Day 1 ]

Central Contacts

• Takeda Contact
  +1-877-825-3327
  [email protected]

Locations (1)

Find similar trials in La Jolla, CA

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