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

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Idiopathic Constipation (CIC)
• Intervention / Treatment: Other: No Intervention

• Study Type: Observational
• Enrollment (Estimated): 12

Contacts and Locations

• Study Contact: Name: Takeda Contact; Phone Number: +1-877-825-3327; Email: medinfoUS@takeda.com

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92093
      • Recruiting
      • University of California San Diego
      • Principal Investigator: Christina Chambers, PhD, MPH
      • Contact: Site Contact; Phone Number: 858-246-1704; Email: chchambers@health.ucsd.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; This is a non-interventional study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Infants With Adverse Events (AEs) Based on Maternal Report	Number of infants with AEs while being breastfed by a mother who is taking prucalopride will be obtained by maternal report (by phone).	Up to 1 year of age
Change in Length During the First Year of Life in Infant's	Growth changes in length in centimeters every 2 months during the first year of life in infant's breastfed by mothers taking prucalopride will be obtained by maternal report (by phone), and medical records abstraction.	At 6 and 12 months of age
Change in Weight During the First Year of Life in Infant's	Growth changes in weight in grams every 2 months during the first year of life in infant's breastfed by mothers taking prucalopride will be obtained by maternal report (by phone), and medical records abstraction.	At 6 and 12 months of age
Change in Head Circumference During the First Year of Infant's Life	Change in head circumference at 6 and 12 months will be reported.	At 6 and 12 months of age
Infant's Neurodevelopmental Performance Based on Ages and Stages Questionnaire-3 (ASQ-3)	Infant's neurodevelopmental progress at 12 months will be assessed by the ASQ-3 which will be completed by the mother. The ASQ-3 is a developmental screening instrument with 5 domains: (i) personal-social, (ii) gross motor, (iii) fine motor, (iv) problem solving, and (v) communication. All domains will be evaluated both continuously and categorically, with 3 categories: normal, borderline, abnormal. Abnormal scores of clinical concern are defined by test-based, standardized scoring criteria reported in the ASQ-3 User's Guide; these represent scores that are <2.0 SDs below the mean for each category. Borderline scores are scores that fall between 2.0 and 1.5 SDs below the mean. Each domain has 6 questions, if the answer is Yes, score = 10, Sometimes = 5 and Not yet = 0. ASQ-3 average = average score of 5 aspects.	Up to 1 year of age

Collaborators and Investigators

• Sponsor: Takeda
• Collaborators: UC San Diego Human Milk Research Biorepository
• Investigators: Study Director: Study Director, UC San Diego Human Milk Research Biorepository; Study Director: Study Director, Takeda

Publications and helpful links

Helpful Links

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 2, 2022
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): October 31, 2027

Study Registration Dates

• First Submitted: March 25, 2021
• First Submitted That Met QC Criteria: April 8, 2021
• First Posted (Actual): April 9, 2021

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Pharmacokinetics; Lactation; Breastfeeding; Prucalopride; Motegrity; Milk-only study; Infant growth and development; Infant neurodevelopment; Infant outcomes
• Additional Relevant MeSH Terms: Behavior; Feeding Behavior; Breast Feeding
• Other Study ID Numbers: TAK-555-4006; EUPAS40105 (Other Identifier: EUPAS Register Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: De-identified individual participant data from this particular study will not be shared as the data are subject to contractual (or consent) provisions that prohibit transfer to third parties.
• IPD Sharing Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Study Data/Documents

1. Breast Milk At the Dawn of New Discoveries

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No