Summary

Eligibility
for females ages 18 years and up (full criteria)
Location
at La Jolla, California
Dates
study started
estimated completion
Principal Investigator
by Christina Chambers

Description

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.

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

Keywords

Chronic Constipation Prucalopride Motegrity Pharmacokinetics Lactation Breastfeeding Milk-only study Infant growth and development Infant neurodevelopment Infant outcomes Constipation No Intervention

Eligibility

You can join if…

Open to females ages 18 years and up

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.

You CAN'T join if...

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.

Location

  • University of California San Diego accepting new patients
    La Jolla California 92093 United States

Lead Scientist at UCSD

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Takeda
Links
To obtain more information on the study, click here/on this link
ID
NCT04838522
Study Type
Observational
Last Updated