Clinical trial NCT04838522: A Study of Prucalopride in Breastfeeding Women With Constipation
Official 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Idiopathic Constipation (CIC)
Keywords: Prucalopride
Motegrity
Pharmacokinetics
Lactation
Breastfeeding
Milk-only study
Infant growth and development
Infant neurodevelopment
Infant outcomes
Lead sponsor: Takeda
Sponsor class: INDUSTRY
Collaborators: name: UC San Diego Human Milk Research Biorepository
First posted: 2021-04-09
Enrollment: 12
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Dose- Normalized Area Under the Milk Concentration-time Curve of Prucalopride (AUC [milk, norm])
timeFrame: Pre-dose, 1, 2, 4, 8, 12, and 24 hours post-dose on Day 1
measure: Dose- Normalized Average Concentration of Prucalopride in Milk (C [ave, milk, norm])
timeFrame: Pre-dose, 1, 2, 4, 8, 12, and 24 hours post-dose on Day 1
measure: Time Interval Over Which the AUC [milk, norm] Measured (T)
timeFrame: Pre-dose, 1, 2, 4, 8, 12, and 24 hours post-dose on Day 1
measure: Dose-normalized Daily Infant Dosage (DID [norm])
timeFrame: Pre-dose, 1, 2, 4, 8, 12, and 24 hours post-dose
measure: Percentage of Maternal Dose or Relative Infant Dose (RID [%])
timeFrame: Up to 24 hours post-dose
Secondary outcomes:
measure: Number of Infants With Adverse Events (AEs) Based on Maternal Report
timeFrame: Up to 1 year of age
measure: Change in Length During the First Year of Life in Infant's
timeFrame: At 6 and 12 months of age
measure: Change in Weight During the First Year of Life in Infant's
timeFrame: At 6 and 12 months of age
measure: Change in Head Circumference During the First Year of Infant's Life
timeFrame: At 6 and 12 months of age
measure: Infant's Neurodevelopmental Performance Based on Ages and Stages Questionnaire-3 (ASQ-3)
timeFrame: Up to 1 year of age
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: University of California San Diego
state: California
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
affiliation: UC San Diego Human Milk Research Biorepository
name: Study Director
role: STUDY_DIRECTOR
References: