A Study of Prucalopride in Breastfeeding Women With Constipation

NCT04838522 | Recruiting FDA Drug

• 2 other identifiers: TAK-555-4006EUPAS40105
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

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)

Keywords

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

Outcome Measures

Primary Outcomes (5)

• Dose- Normalized Area Under the Milk Concentration-time Curve of Prucalopride (AUC [milk, norm])

  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.

  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])

  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.

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

  Pre-dose, 1, 2, 4, 8, 12, and 24 hours post-dose on Day 1

• Dose-normalized Daily Infant Dosage (DID [norm])

  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.

  Pre-dose, 1, 2, 4, 8, 12, and 24 hours post-dose

• Percentage of Maternal Dose or Relative Infant Dose (RID [%])

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

  Up to 24 hours post-dose

Secondary Outcomes (5)

• Number of Infants With Adverse Events (AEs) Based on Maternal Report

  Up to 1 year of age

• Change in Length During the First Year of Life in Infant's

  At 6 and 12 months of age

• Change in Weight During the First Year of Life in Infant's

  At 6 and 12 months of age

• Change in Head Circumference During the First Year of Infant's Life

  At 6 and 12 months of age

• Infant's Neurodevelopmental Performance Based on Ages and Stages Questionnaire-3 (ASQ-3)

  Up to 1 year of age

Study Arms (1)

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.

Other: No Intervention

Interventions

No Intervention OTHER

This is a non-interventional study.

All Study Participants

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Female participants from United State (US) and Canada, who are currently being treated with prucalopride for functional constipation and breastfeeding a single infant between the ages of 10 days and 11 months 0 days. Infants will be followed for up to 12 months 30 days of age.

You may qualify if:

• 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 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Takeda: lead
• UC San Diego Human Milk Research Biorepository: collaborator

Study Sites (1)

University of California San Diego

La Jolla, California, 92093, United States

RECRUITING

Related Links

• Click here for more information about this trial in easy-to-understand language, including a Plain Language Summary of the results if the trial has been completed.
• Click here to ask Takeda's chatbot for comprehensive and easy-to-understand information about clinical trials - even across products and indications - in your local language.

Biospecimen

Retention: SAMPLES WITHOUT DNA

Breast milk

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

• Study Director

  UC San Diego Human Milk Research Biorepository

  STUDY DIRECTOR

Central Study Contacts

Takeda Contact

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2021
• First Posted: April 9, 2021
• Study Start: March 2, 2022
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): October 31, 2027
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)