Study type

Study topic

Human medicinal product
Disease /health condition

Study type

Non-interventional study

Scope of the study

Drug utilisation
Effectiveness study (incl. comparative)

Data collection methods

Secondary use of data
Non-interventional study

Non-interventional study design

Cohort
Cross-sectional
Other

Non-interventional study design, other

Cross-sectional retrospective analysis
Study drug and medical condition

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

PRIDINOL MESILATE

Medical condition to be studied

Musculoskeletal pain
Population studied

Short description of the study population

Patients with muscle pain (MP) in routine clinical practice who were registered in the German Pain e-Registry.

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

1100
Study design details

Main study objective

Main objective of this analysis is to gain further insight into the differential effects and the benefit-risk profile (BRP) of pridinol given add-on to patients with elsewhere refractory muscle pain under real life conditions.

Outcomes

Primary efficacy endpoint analysis based on a combined responder concept. Responders are defined with respect to their response to two different criteria (at least 50% improvement and or improvement equal to or greater than th minimal clinical important difference of average 24-hour pain (PIX), pain-related disabilities in daily life (mPDI), vs. baseline. Secondary endpoints evaluate further efficacy, tolerability and safety data as provided by patients during the use of the medication under evaluation.

Data analysis plan

Exploratory analysis of anonymized routine/open-label data of the German Pain e-Registry (GPR) on adult MP patients, in whom a treatment with pridinol has been initiated in compliance with the current German prescribing regulations between January 1st 2018 and December 31st, 2020. No formal sample size analysis will be performed. Data analyses will be performed for all registered patients who took at least one dose of study medication and who had at least one post-baseline/post-dose measure (modified intent-to-treat approach).