Status: Finalised First registered on: 29/09/2014
Last updated on: 21/03/2019
1. Study identification
EU PAS Register NumberEUPAS7545
Official titleThe risk of ischemic cardiovascular events associated with oxycodone/naloxone use
Study title acronym
Study typeObservational study
Brief description of the studyOpioid-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.
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)? Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsBIPS GmbH
Department/Research groupClinical Epidemiology
Organisation/affiliationLeibniz Inst. for Prevention Research and Epidem.
Website/Homepagewww.bips.eu
Details of (Primary) lead investigator
Title Dr
Last name Schink
First name Tania
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Not applicable (single centre)

Countries in which this study is being conducted
National study

Germany
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed08/09/201308/09/2013
Start date of data collection01/01/200401/01/2004
Start date of data analysis15/04/201415/04/2014
Date of interim report, if expected15/10/201405/12/2014
Date of final study report31/12/201431/12/2014
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesPurdue Pharma L.P.100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Schink
First name Tania
Address line 1Achterstraße 30
Address line 2 
Address line 3 
CityBremen 
Postcode28359 
CountryGermany
Phone number (incl. country code)004942121856860 
Alternative phone number 
Fax number (incl. country code) 
Email address schink@leibniz-bips.de
Public Enquiries
Title Dr 
Last name Gerds 
First name Heike 
Address line 1Achterstraße 30 
Address line 2 
Address line 3 
CityBremen 
Postcode28359 
CountryGermany 
Phone number (incl. country code)004942121856860 
Alternative phone number 
Fax number (incl. country code) 
Email address gepard@leibniz-bips.de 
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