Study identification

PURI

https://redirect.ema.europa.eu/resource/29020

EU PAS number

EUPAS7545

Study ID

29020

Official title and acronym

The risk of ischemic cardiovascular events associated with oxycodone/naloxone use

DARWIN EU® study

No

Study countries

Germany

Study description

Opioid-induced constipation (OIC) is one of the most common adverse effects of opioid therapy and several approaches have been made to reverse OIC without compromising pain relief. Targin® is an oral fixed combination of the extended-release (ER) high potency opioid (HPO) oxycodone and the opioid antagonist naloxone. It is approved in Germany for the treatment of severe pain and has been proven to provide comparable analgesic efficacy to that of oxycodone, while improving OIC. However, the long-term safety of opioid antagonists is not clear. The FDA for example expressed concerns over potential cardiac safety risks associated with use of opioid antagonists discussing withdrawal as possible cause for these risks. This study will estimate the risk of cardiovascular events such as myocardial infarction or ischemic stroke in patients receiving oxycodone/naloxone compared to those being treated with ER oxycodone or another ER HPO.

Study status

Finalised
Research institution and networks

Institutions

Contact details

Tania Schink

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Data collection

Planned:
Actual:

Start date of data analysis

Planned:
Actual:

Date of interim report, if expected

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Purdue Pharma L.P.
Regulatory

Was the study required by a regulatory body?

No

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

Not applicable