TAK-555-4006: 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

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/48470
• EU PAS number:
  EUPAS40105
• Study ID:
  48470
• Official title and acronym:
  TAK-555-4006: 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
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study 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 collect information on the growth and development of infants whose mothers took prucalopride while breastfeeding and to monitor the infant for medication side effects.
• Study status:
  Ongoing

Research institutions and networks

Institutions

UC San Diego Human Milk Research Biorepository

Study timelines

Date when funding contract was signed

Actual: 19/09/2019

Study start date

Actual: 02/03/2022

Data analysis start date

Planned: 31/10/2027

Date of final study report

Planned: 30/04/2028

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Takeda

Study protocol

Initial protocol

TAK-555-4006 Protocol V1.1_redacted.pdf

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Non-EU RMP only