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Prucalopride in Breastfeeding Women With Constipation

This study is looking at prucalopride, a medicine used to treat constipation, in breastfeeding women. The main goal is to measure how much prucalopride gets into breast milk. Researchers also want to see how babies breastfed by mothers taking prucalopride grow and develop, and if they have any side effects. You may be able to join if you are a woman aged 18 or older and can provide informed consent. This study is observational, meaning there is no intervention given, and aims to enroll 12 participants. The study will measure the amount of prucalopride in milk over 24 hours and follow up on baby development for the first year.

Study design
This is an observational study with a planned enrollment of 12 women. It is not specified if it is randomized, blinded, or what phase it is in.
What's involved
You will provide one set of breast milk samples over 24 hours at home using an electric breast pump. You will also participate in telephone interviews every 2 months and complete questionnaires about your baby's growth and development for the first year.
Compensation
Not stated in the trial record.
Follow-up
You will be asked questions during telephone interviews every 2 months in the first year of your baby's life.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04838522

A Study of Prucalopride in Breastfeeding Women With Constipation

Recruiting
Not specifiedAges 18+Observational
Takeda
~12 participants
Updated 2026-05-01 on ClinicalTrials.gov
What's tested:No Intervention

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Dose- Normalized Area Under the Milk Concentration-time Curve of Prucalopride (AUC [milk, norm])
Measured over Pre-dose, 1, 2, 4, 8, 12, and 24 hours post-dose on Day 1
+4 more outcomes measured

Conditions

Chronic Idiopathic Constipation (CIC)

Explore related trials

Chronic idiopathic constipationIrritable Bowel Syndrome

Where it's being run

1 sites across 1 states
California1

Study leadership

  • Study Director · STUDY_DIRECTOR · Takeda
  • Study Director · STUDY_DIRECTOR · UC San Diego Human Milk Research Biorepository

Who to contact

Takeda Contact
[email protected]
+1-877-825-3327
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

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

    AUC \[milk, norm\] will be derived from a series of 7 timed, full expression breast milk samples collected from a single breast using an electric breast pump over a 24-hour period of milk collection after a dose following at least 5 consecutive daily doses. AUC \[milk, norm\] will be normalized to 2-milligrams (mg) daily maternal dose.

  • Dose- Normalized Average Concentration of Prucalopride in Milk (C [ave, milk, norm])Pre-dose, 1, 2, 4, 8, 12, and 24 hours post-dose on Day 1

    C \[ave, milk, norm\] will be derived from a series of 7 timed, full expression breast milk samples collected from a single breast using an electric breast pump over a 24-hour period of milk collection after a dose following at least 5 consecutive daily doses. C \[ave, milk, norm\] will be normalized to 2-mg daily maternal dose.

  • Time Interval Over Which the AUC [milk, norm] Measured (T)Pre-dose, 1, 2, 4, 8, 12, and 24 hours post-dose on Day 1

    Time interval over which the AUC \[milk, norm\] is measured (T) will be reported.

  • Dose-normalized Daily Infant Dosage (DID [norm])Pre-dose, 1, 2, 4, 8, 12, and 24 hours post-dose

    DID \[norm\] will be the estimated daily infant dose received by the infant through breastfeeding. DID \[norm\] will be normalized to 2-mg daily maternal dose.

  • Percentage of Maternal Dose or Relative Infant Dose (RID [%])Up to 24 hours post-dose

    RID \[%\]will be calculated as DID \[norm\] divided by (2 mg/day/maternal body weight (kg)) then multiplied by 100.