Retrosepctive Analysis of the efficacy and tolerability of pridinol in patients with muscle pain - an analysis of open-label real-world data provided by the German Pain e-Registry (PriMePain)

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:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 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).