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NCT Number: NCT04838522

A Study of Prucalopride in Breastfeeding Women With Constipation

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.

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Key information

Conditions

Chronic Idiopathic Constipation (CIC) Behavior Breast Feeding Feeding Behavior

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

University of California San Diego

La Jolla, California, 92093, United States

Location status: Recruiting

Location contact

Christina Chambers, PhD, MPH

PRINCIPAL_INVESTIGATOR

Site Contact

CONTACT

[email protected]

858-246-1704

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No intervention

Other

This is a non-interventional study.

Primary outcomes

  1. 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

    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.

  2. 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

    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.

  3. 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

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

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

    Time frame: 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.

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

    Time frame: 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.

Secondary outcomes

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

    Time frame: Up to 1 year of age

    Number of infants with AEs while being breastfed by a mother who is taking prucalopride will be obtained by maternal report (by phone).

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

    Time frame: At 6 and 12 months of age

    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.

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

    Time frame: At 6 and 12 months of age

    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.

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

    Time frame: At 6 and 12 months of age

    Change in head circumference at 6 and 12 months will be reported.

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

    Time frame: Up to 1 year of age

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Takeda Contact

CONTACT

[email protected]

+1-877-825-3327

Sponsors and collaborators

Lead sponsor

Takeda

Industry

Collaborators

  • UC San Diego Human Milk Research Biorepository

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Apr 9, 2021
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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