Study type

Study topic

Human medicinal product

Study type

Non-interventional study

Scope of the study

Drug utilisation

Data collection methods

Secondary use of data
Study drug and medical condition

Study drug International non-proprietary name (INN) or common name

TRAMADOL
Population studied

Short description of the study population

Adult patients who were prescribed with tramadol in general practice and continuously provided data over a 10-year period from 1 January 2006 to 30 June 2016 from French and German primary care electronic health record data from IMS® Disease Analyzer (October 2016 release).

Age groups

Adults (18 to < 46 years)
Adults (46 to < 65 years)
Adults (65 to < 75 years)
Adults (75 to < 85 years)
Adults (85 years and over)

Estimated number of subjects

100000
Study design details

Main study objective

The objectives of the study are to examine patterns of tramadol prescribing between 2006 and 2016 using data from France, Germany and the UK, with a focus on incident and prevalent tramadol prescribing, dose and duration of tramadol prescribing, clinical indications for tramadol prescribing.

Outcomes

Trends in incident and prevalent tramadol prescribing overall and by age and gender. Clinical conditions recorded for people prescribed tramadol.

Data analysis plan

A descriptive analysis and yearly trends of tramadol prescribing will be measured in each database. The numerator will consist of a) patients prescribed tramadol and b) number of tramadol prescriptions. The denominator will consist of all other patients present in the database during the same year. Dose and duration of tramadol will be calculated using prescription information, with complete case analysis and imputation for missing prescription data applied.
Documents
Study results
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