An Observational Post-Authorisation Safety Study (PASS) of Patients with Chronic Opioid Use for Non-Cancer Pain and Cancer Pain who have Opioid-Induced Constipation (OIC) (Naldemedine PASS)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/47104
• EU PAS number:
  EUPAS43258
• Study ID:
  47104
• Official title and acronym:
  An Observational Post-Authorisation Safety Study (PASS) of Patients with Chronic Opioid Use for Non-Cancer Pain and Cancer Pain who have Opioid-Induced Constipation (OIC) (Naldemedine PASS)
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom

  United States
• Study description:
  The study will be conducted using validated research-acceptable healthcare data sources to investigate investigates the real-world incidence of major adverse CV outcomes and GI perforation in patients receiving chronic opioid therapy and who have newly initiated naldemedine for OIC (naldemedine cohort), or who are newly prescribed a non-OTC and non-PAMORA medication for OIC with no evidence of prior prescribing (or dispensing) of any PAMORA (reference cohort).
• Study status:
  Planned

Research institution and networks

Institutions

United BioSource Corporation (UBC)

Switzerland

Study timelines

Date when funding contract was signed

Planned: 15/03/2021

Actual: 15/03/2021

Study start date

Planned: 30/12/2021

Data analysis start date

Planned: 31/03/2028

Date of interim report, if expected

Planned: 31/12/2022

Date of final study report

Planned: 29/12/2028

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Shionogi BV

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)