1. Study identification
EU PAS Register NumberEUPAS15418
Official titleLocalised Neuropathic Pain (LNP) managed in the primary care setting in France, Ireland, Italy, Spain, and the United Kingdom: A cross-sectional study of prevalence, clinical characteristics, treatment patterns and patient’s reported outcomes
Study title acronymLNP
Study typeObservational study
Brief description of the studyTopical application of analgesics can offer a valid therapeutic alternative, providing Localised Neuropathic Pain (LNP) is recognised. To date only sparse data are available in literature about the features of LNP, its therapeutic management and its frequency in the primary care population in Europe. This study will attempt to fill such a knowledge gap in the primary care population of five EU countries, namely France, Ireland, Italy, Spain and the United Kingdom. Data on the frequency of LNP and the clinical profile of patients showing signs and symptoms of LNP, their current treatment patterns, and patient’s reported health status, including quality of sleep, can help to identify unmet medical needs in such a problematic therapeutic area.
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 belongsOXON
Department/Research group
Organisation/affiliationOxon Epidemiology Ltd.
Details of (Primary) lead investigator
Title Dr
Last name Qizilbash
First name Nawab
Is this study being carried out with the collaboration of a research network?
Yes
National Institute for Health Research (UK)
Other centres where this study is being conducted
Multiple centres
In total how many centres are involved in this Study?50
Countries in which this study is being conducted
International study
France
Ireland
Italy
Spain
United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed01/04/2016
Start date of data collection01/10/201613/12/2016
Start date of data analysis
Date of interim report, if expected
Date of final study report04/07/2018
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesGrunenthal GmbH100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Qizilbash
First name Nawab
Address line 1The Euston Office
Address line 21 Euston Square
Address line 340 Melton Street
CityLondon
PostcodeNW1 2FD
CountryUnited Kingdom
Phone number (incl. country code)442035744965
Alternative phone number
Fax number (incl. country code)
Public Enquiries
Title Dr
Last name Qizilbash
First name Nawab
Address line 1The Euston Office
Address line 21 Euston Square
Address line 340 Melton Street
CityLondon
PostcodeNW1 2FD
CountryUnited Kingdom
Phone number (incl. country code)442035744965
Alternative phone number
Fax number (incl. country code)
11. Scope of the study
What is the scope of the study?
Disease epidemiology
Drug utilisation study
Primary scope : Drug utilisation study
12. Main objective(s)
What is the main objective of the study?
To describe treatment characteristics and patterns of treatment of LNP patients identified among chronic pain patients in primary care in 5 EU countries.
Are there primary outcomes?Yes
The primary endpoints for the study will be the important clinical and treatment characteristics at the time of the visit, including but not limited to: clinical characteristics, aetiology of LNP, co-morbidities and therapy for chronic pain in the 6 moths preceding the screening, current analgesia for chronic pain
Are there secondary outcomes?Yes
- EQ-5D score (Patient’s self-reported health status)
- CPSI scores (Patient’s self-reported quality of sleep)
- Prevalence of LNP
13. Study design
What is the design of the study?
Cross-sectional 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
Analyses will be mainly descriptive in nature. Categorical data will be summarized by counts and percentages. Continuous data will be summarized using number, mean, standard deviation (SD), median, quartiles, minimum and maximum and in the case of non-normally distributed data, median, range and interquartile range. All statistical tests used for comparisons to assess differences or associations will be 2-sided and conducted at the 0.05 alpha level. P-values will be presented to three decimal places.