Recruiting

Prucalopride

Sponsor:

Takeda

Code:

NCT04838522

Conditions

Chronic Idiopathic Constipation (CIC)

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

No Intervention

Study Details

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

Conditions

Chronic Idiopathic Constipation (CIC)

Study ID

NCT04838522

Start date

Mar 2, 2022

Status verified date

Apr, 2026

Completion date

Oct 31, 2027

Anticipated

Primary completion date

Oct 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Participants cannot be enrolled before all inclusion criteria are confirmed.

  • Female participants with an ability to voluntarily provide verbal followed by written, signed, and dated (personally or via a legally authorized representative) informed consent as applicable to participate in the study.
  • Participants greater than or equal to (>=) 18 years of age at the time of consent. This inclusion criterion will only be assessed at the time of enrollment.
  • Participants who are currently breastfeeding a singleton infant who is between 10 days and 11 months 0 days, inclusive. Note that participants pumping breast milk and bottle feeding their infant breast milk are allowed to participate.
  • Participants who are currently exclusively breastfeeding or breastfeeding with supplemental formula and/or solid food. Infants who are exclusively breastfed and do not yet eat solid food are preferred.
  • Participants who are currently treated as prescribed by their physician with MOTEGRITY or RESOTRAN (generic forms of prucalopride not allowed) for functional constipation, including chronic idiopathic constipation (CIC) and irritable bowel syndrome-constipation (IBS-C), for at least 5 consecutive days at the time of taking the first breastmilk sample.
  • Participants who agree to the conditions and requirements of the study including the sample collection, interview schedule, completion of developmental questionnaires, and release of medical records.
  • Participants with an understanding, ability, and willingness to fully comply with study procedures and restrictions.

Exclusion Criteria:

The participant will be excluded from the study if any of the following exclusion criteria are met:

  • Participants who are breastfeeding an infant who: is hospitalized, has a major birth defect, or has a history of a disease that could affect absorption or drug disposition.
  • Participants who have used MOTEGRITY or RESOTRAN while breastfeeding for a condition other than functional constipation.
  • Participants who are pregnant at the time of enrollment.
  • Participants who have started to wean their child from breast milk.
  • Participants with a history of any hematological, hepatic, respiratory, cardiovascular, renal, gall bladder removal, or other current or recurrent disease that could affect the action, absorption, or disposition of prucalopride.

Study Design

Enrollment

12 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

No Intervention

This is a non-interventional study.

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 ]
  • Dose- Normalized Average Concentration of Prucalopride in Milk (C [ave, milk, norm]) [ Time Frame: Pre-dose, 1, 2, 4, 8, 12, and 24 hours post-dose on Day 1 ]
  • Time Interval Over Which the AUC [milk, norm] Measured (T) [ Time Frame: Pre-dose, 1, 2, 4, 8, 12, and 24 hours post-dose on Day 1 ]
  • Dose-normalized Daily Infant Dosage (DID [norm]) [ Time Frame: Pre-dose, 1, 2, 4, 8, 12, and 24 hours post-dose ]
  • Percentage of Maternal Dose or Relative Infant Dose (RID [%]) [ Time Frame: Up to 24 hours post-dose ]

Central Contacts and Locations

Central contacts

Takeda Contact

+1-877-825-3327medinfoUS@takeda.com

Locations

University of California San Diego

Recruiting

La Jolla, California, United States, 92093

Contacts

Site Contact

858-246-1704chchambers@health.ucsd.edu

Principal Investigator:

Christina Chambers, PhD, MPH

More Information

Sponsor

Takeda

Last update posted

May 1, 2026

Last verified

Apr, 2026

Keywords

  • Prucalopride
  • Motegrity
  • Pharmacokinetics
  • Lactation
  • Breastfeeding
  • Milk-only study
  • Infant growth and development
  • Infant neurodevelopment
  • Infant outcomes

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-25. This information was provided to ClinicalTrials.gov by Takeda on 2026-05-01. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.