Status: Finalised
First registered on:
30/06/2015
Last updated on:
27/02/2017
1. Study identification
EU PAS Register NumberEUPAS10129
Official titlePrevalence and Incidence of Problematic Prescription Opioid Use and Abuse in the United Kingdom and Germany
Study title acronymOXY9504
Study typeObservational study
Brief description of the study
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 belongsIMS Health
Department/Research groupReal World Evidence Solutions
Organisation/affiliationIMS Health
Details of (Primary) lead investigator
Title Dr
Last name Kim
First name Joseph
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
International study
Germany
United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed11/11/201302/12/2013
Start date of data collection11/03/201408/04/2014
Start date of data analysis25/05/2015
Date of interim report, if expected
Date of final study report25/05/201627/06/2016
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesMundipharma Research Ltd100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Andrew
First name Cooper
Address line 1Mundipharma Research Ltd
Address line 2
Address line 3
CityCambridge
Postcode
CountryUnited Kingdom
Phone number (incl. country code)441223397003
Alternative phone number
Fax number (incl. country code)
Public Enquiries
Title Dr
Last name Andrew
First name Cooper
Address line 1Mundipharma Research
Address line 2
Address line 3
CityCambridge
Postcode
CountryUnited Kingdom
Phone number (incl. country code)441223397003
Alternative phone number
Fax number (incl. country code)
6. Study drug(s) information
Substance class (ATC Code)N02A (OPIOIDS)
7. Medical conditions to be studied
Medical condition(s)Yes
Drug abuse
8. Population under study
Age
Infants and toddlers (28 days - 23 months)
Children (2 - 11 years)
Adolescents (12 - 17 years)
Adults (18 - 44 years)
Adults (45 - 64 years)
Adults (65 - 74 years)
Adults (75 years and over)
Sex
Male
Female
9. Number of subjects
Estimated total number of subjects180000
Additional information
UK 1,600,000; DE 180,000
10. Source of data
Is this study being carried out with an established data source?Yes
Data sources registered with ENCePP
Data sources not registered with ENCePP
IMS Disease Analyser, Germany
Sources of data
Routine primary care electronic patient registry
11. Scope of the study
What is the scope of the study?
Risk assessment
Drug utilisation study
Primary scope : Risk assessment
12. Main objective(s)
What is the main objective of the study?
Quantify problematic prescription use and abuse of prescription opioids in Germany and the United Kingdom
Are there primary outcomes?Yes
Incidence and 5-year prevalence of problematic prescription use and abuse of prescription opioids from 2008-2012
Are there secondary outcomes?Yes
Characterisation of the abusing and non-abusing population: demographics, drug utilisation.
13. Study design
What is the design of the study?
Cohort study
14. Follow-up of patients
Will patients be followed up?Not applicable/no follow-up
15. Data analysis plan
Please provide a brief summary of the analysis method
Calculation of incidence rate and 5-year prevalence of problematic use of prescription opioids per molecule from 2008 to 2012.
16. ENCePP seal
Are you requesting the ENCePP seal for this study?
No
17. Full protocol
Not submitted
18. Study Results
Not submitted
Please list the 5 most relevant publications using data from your study
ReferenceLink to web-publication
None
19. Other relevant documents
Conflict(s) of interest of
investigator(s)Not submitted
Composition of Steering Group and
ObserversNot submitted
Other documentsNot
submitted
Signed Code of
Conduct Checklist
Not submitted
Signed Code of Conduct Declaration
Not submitted
Signed Checklist for Study
Protocols
Not submitted
