A Study of Prucalopride in Breastfeeding Women With Constipation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: No Intervention.
- Who it may be relevant to
- Registry conditions: Chronic Idiopathic Constipation (CIC). Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- Other No Intervention
This is a non-interventional study.
Primary outcome measures
- 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]
- 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]
- 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]
- Dose-normalized Daily Infant Dosage (DID [norm]) [Time frame: Pre-dose, 1, 2, 4, 8, 12, and 24 hours post-dose]
- Percentage of Maternal Dose or Relative Infant Dose (RID [%]) [Time frame: Up to 24 hours post-dose]
Secondary outcome measures (5)
- Number of Infants With Adverse Events (AEs) Based on Maternal Report [Time frame: Up to 1 year of age]
- Change in Length During the First Year of Life in Infant's [Time frame: At 6 and 12 months of age]
- Change in Weight During the First Year of Life in Infant's [Time frame: At 6 and 12 months of age]
- Change in Head Circumference During the First Year of Infant's Life [Time frame: At 6 and 12 months of age]
- Infant's Neurodevelopmental Performance Based on Ages and Stages Questionnaire-3 (ASQ-3) [Time frame: Up to 1 year of age]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- University of California San Diego — La Jolla
Identifiers
NCT: NCT04838522 · TAK-555-4006 · EUPAS40105