RECRUITING

A Study of Prucalopride in Breastfeeding Women With Constipation

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Conditions

Chronic Idiopathic Constipation (CIC)PrucaloprideMotegrityPharmacokineticsLactationBreastfeedingMilk-only studyInfant growth and developmentInfant neurodevelopmentInfant outcomes

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2022-03-02
Study Completion:2026-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04838522

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. * 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.
  3. * Participants who are currently breastfeeding a singleton infant who is between 10 days and 11 months 0 days. Note that participants pumping breast milk and bottle feeding their infant breast milk are allowed to participate.
  4. * 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.
  5. * 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.
  6. * 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.
  7. * Participants with an understanding, ability, and willingness to fully comply with study procedures and restrictions.
  1. * 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.
  2. * Participants who have used MOTEGRITY or RESOTRAN while breastfeeding for a condition other than functional constipation.
  3. * Participants who are pregnant at the time of enrollment.
  4. * Participants who have started to wean their child from breast milk.
  5. * 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

Study Contact

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

Principal Investigator

Study Director
STUDY_DIRECTOR
Takeda
Study Director
STUDY_DIRECTOR
UC San Diego Human Milk Research Biorepository

Study Locations (Sites)

University of California San Diego
La Jolla, California, 92093
United States

Collaborators and Investigators

Sponsor: Takeda

  • Study Director, STUDY_DIRECTOR, Takeda
  • Study Director, STUDY_DIRECTOR, UC San Diego Human Milk Research Biorepository

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-03-02
Study Completion Date2026-12-31

Study Record Updates

Study Start Date2022-03-02
Study Completion Date2026-12-31

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Chronic Idiopathic Constipation (CIC)