A Study of Prucalopride in Breastfeeding Women With Constipation

• ClinicalTrials.gov Identifier: NCT04838522
• Recruitment Status: Recruiting
• First Posted: April 9, 2021
• Last Update Posted: August 5, 2022
• Sponsor: Takeda
• Collaborator: UC San Diego Human Milk Research Biorepository
• Information provided by (Responsible Party): Takeda

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
Chronic Constipation	Other: No Intervention

Study Design

• Study Type: Observational
• Estimated 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: March 2, 2022
• Estimated Primary Completion Date: May 30, 2025
• Estimated Study Completion Date: May 30, 2025

Groups and Cohorts

Group/Cohort	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 :

1. Area Under the Milk Concentration-time Curve (AUCmilk) of Prucalopride [ Time Frame: 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.
2. Average Concentration of Prucalopride in Milk [ Time Frame: 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.
3. Area Under the Milk Concentration-time Curve from Time 0 to Time t Over the Dosing Interval [AUCmilk (0-t)] [ Time Frame: 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 :

1. Number of Infant's With Adverse Events (AEs) Based on Maternal Report [ Time Frame: 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).
2. Change in Length During the First Year of Life in Infant's [ Time Frame: 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.
3. Change in Weight During the First Year of Life in Infant's [ Time Frame: 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.
4. 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 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.

Biospecimen Retention:   Samples With DNA

Breast milk

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Female participants from United State (US), 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.

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.
• 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.

Contacts and Locations

Contacts

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

Locations

United States, California

University of California San Diego; Recruiting

La Jolla, California, United States, 92093

Contact: Site Contact 858-246-1704 chchambers@health.ucsd.edu

Principal Investigator: Christina Chambers, PhD, MPH

Sponsors and Collaborators

Takeda

UC San Diego Human Milk Research Biorepository

Investigators

• Study Director: Study Director; Takeda
• Study Director: Study Director; UC San Diego Human Milk Research Biorepository

More Information

Additional Information:

To obtain more information on the study, click here/on this link 

Study Data/Documents: Breast Milk At the Dawn of New Discoveries 

• Responsible Party: Takeda
• ClinicalTrials.gov Identifier: NCT04838522
• Other Study ID Numbers: TAK-555-4006
• First Posted: April 9, 2021
• Last Update Posted: August 5, 2022
• Last Verified: August 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)
• 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.
• URL: https://vivli.org/ourmember/takeda/

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Takeda:

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

Additional relevant MeSH terms:

Constipation; Signs and Symptoms, Digestive