TAK-555-5002: Observational Study to Assess Maternal and Fetal Outcomes Following Exposure to Prucalopride during Pregnancy

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/45769
• EU PAS number:
  EUPAS41866
• Study ID:
  45769
• Official title and acronym:
  TAK-555-5002: Observational Study to Assess Maternal and Fetal Outcomes Following Exposure to Prucalopride during Pregnancy
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  This study will collect information on pregnant women diagnosed with constipation from their health care insurance claims records. It will include the following groups: - Those who took prucalopride. - Those who took other medicines for constipation. - Those who did not take any prescription medicines for constipation. The main aim of the study is to assess the risk of major birth defects with the mother’s use of prucalopride during the first 3 months of pregnancy. The study uses existing health care insurance information, participants are not enrolled, treated, or required to visit the doctor during this study.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Takeda

Study timelines

Date when funding contract was signed

Actual: 31/05/2019

Study start date

Actual: 01/01/2022

Data analysis start date

Planned: 01/03/2026

Date of final study report

Planned: 30/06/2026

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Takeda

Regulatory

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