A Study of Prucalopride in Breastfeeding Women With Constipation

Sponsor

Takeda (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04838522

Collaborator

UC San Diego Human Milk Research Biorepository (Other)

Enrollment

Location

38.9

Anticipated Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Constipation	Other: No Intervention

Study Design

Study Type:

Observational

Anticipated Enrollment :

12 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

A Breast Milk Study in Lactating Women Who Have Been Prescribed Therapeutic Doses of MOTEGRITY® (Prucalopride) for Chronic Idiopathic Constipation to Evaluate Prucalopride Concentrations in Breast Milk, and to Collect Incidental Safety Data From the Nursing Infant

Actual Study Start Date :

Mar 2, 2022

Anticipated Primary Completion Date :

May 30, 2025

Anticipated Study Completion Date :

May 30, 2025

Arms and Interventions

Arm	Intervention/Treatment
All Study Participants Participants with chronic idiopathic constipation who are treated with prucalopride 2 milligrams (mg) 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.

Arm

Intervention/Treatment

All Study Participants

Participants with chronic idiopathic constipation who are treated with prucalopride 2 milligrams (mg) 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.

Outcome Measures

Primary Outcome Measures

Area Under the Milk Concentration-time Curve (AUCmilk) of Prucalopride [Pre-dose, 1, 2, 4, 8, 12, and 24 hours post-dose on Day 1]
AUCmilk 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 for breast milk prucalopride concentrations.
Average Concentration of Prucalopride in Milk [Pre-dose, 1, 2, 4, 8, 12, and 24 hours post-dose on Day 1]
Average concentration 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 for breast milk prucalopride concentrations.
Area Under the Milk Concentration-time Curve from Time 0 to Time t Over the Dosing Interval [AUCmilk (0-t)] [Pre-dose, 1, 2, 4, 8, 12, and 24 hours post-dose on Day 1]
AUCmilk (0-t) 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 for breast milk prucalopride concentrations.

Secondary Outcome Measures

Number of Infant's With Adverse Events (AEs) Based on Maternal Report [Up to 1 year of age]
Number of infant's with AEs while being breastfed by a mother who is taking prucalopride will be obtained by maternal report (by phone).
Change in Length During the First Year of Life in Infant's [Up to 1 year 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), medical records abstraction, and maternal responses to neurodevelopmental screening questionnaires.
Change in Weight During the First Year of Life in Infant's [Up to 1 year 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), medical records abstraction, and maternal responses to neurodevelopmental screening questionnaires.
Infant's Neurodevelopmental Performance Based on Ages and Stages Questionnaire-3 (ASQ-3) [Up to 1 year of age]
Infant's neurodevelopmental progress at 4 and 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. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.
Healthy female participants as determined by the investigator on the basis of enrollment evaluations.
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.
Participants who are currently exclusively breastfeeding or breastfeeding with supplemental formula and/or solid food. Infants who are exclusively breastfed and do not eat solid food are preferred.
Participants who are currently treated as prescribed by their physician with prucalopride for functional constipation for at least 5 consecutive days at the time of taking the first breastmilk sample. All recommendations in the United States Prescribing Information (US PI) should be followed.
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 prucalopride 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.