TAK-555-5001: Prucalopride Pregnancy Exposure Study: A VAMPSS Post-Marketing Surveillance of Prucalopride Safety in Pregnancy

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/48262
• EU PAS number:
  EUPAS40231
• Study ID:
  48262
• Official title and acronym:
  TAK-555-5001: Prucalopride Pregnancy Exposure Study: A VAMPSS Post-Marketing Surveillance of Prucalopride Safety in Pregnancy
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  This study collects information on pregnant women with ongoing constipation who took prucalopride and those who did not take prucalopride. The main aim of the study is to learn if any medical problems in pregnant women or their infants might be related to taking prucalopride during their pregnancy.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Organization of Teratology Information Specialists (OTIS)

Study timelines

Date when funding contract was signed

Actual: 01/06/2019

Study start date

Actual: 21/05/2021

Data analysis start date

Planned: 19/12/2025

Date of final study report

Planned: 26/06/2026

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Takeda

Study protocol

Initial protocol

TAK-555-5001 Protocol V4.0_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

Other study registration identification numbers and links

ClinicalTrials.gov: NCT04869280

Study information