Study identification

PURI

https://redirect.ema.europa.eu/resource/104165

EU PAS number

EUPAS104164

Study ID

104165

Official title and acronym

Association between opioid use and the development of diverticulitis (Opioids Diverticulitis)

DARWIN EU® study

No

Study countries

Canada
United Kingdom
United States

Study description

While opioid use has been established as a risk factor for diverticulitis, there is limited evidence on the association between opioid analgesics and diverticulitis. The objective of this study is to evaluate whether opioid use is associated with elevated risk of diverticulitis in patients indicated for treatment with opioids. We will carry out separate population-based cohort studies using administrative health databases from five Canadian provinces, the United Kingdom, and the United States. Results from the separate sites will be combined to provide an overall assessment of the risk of diverticulitis in users of opioids.

Study status

Finalised
Research institutions and networks

Institutions

University of Calgary Calgary, Canada, University of British Columbia (British Columbia and MarketScan) Vancouver, Canada, University of Manitoba Winnipeg, Canada, ICES Toronto, Canada, Saskatchewan Health Quality Council Saskatoon, Canada, Lady Davis Institute (CPRD) Montreal, Canada

Contact details

Michael Webster-Clark

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
Other

More details on funding

CADTH (Canadian Agency for Drugs and Technologies in Health)
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

Not applicable