Retrospective Chart Review to Evaluate the Effectiveness of the Risk Minimization Measures for the Use of Flupirtine 100 mg Immediate-Release Capsules in daily Practice (Flupirtine-3300)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Retrospective Chart Review (RCR), Post-authorization safety study (PASS)

Study drug and medical condition

• Medical condition to be studied:
  Pain

Population studied

• Short description of the study population:
  Physicians with at least one flupirtine IR treated patient in at least one of the three specified 6-month time periods in 2012, 2014 or 2015.
• 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:
  1200

Study design details

• Main study objective:
  The overall research goal is to assess the effectiveness of the risk minimization measures for flupirtine 100 mg immediate-release capsules (flupirtine IR) by evaluating to which extent these measures are implemented in daily practice.
• Outcomes:
  To assess the overall compliance with the approved SmPC and the implemented risk minimization measures before (2012) and after the referral procedure and dissemination of the educational material (2015) by overall percentage of patients treated without compliance to the introduced risk minimization measures. To assess the overall compliance with the approved SmPC and the implemented risk minimization measures before (2012) and after the referral procedure (2014) by overall percentage of patients treated without compliance to the introduced riskminimization measures.To assess the extent of compliance.
• Data analysis plan:
  Statistical analyses will be exploratory using descriptive and inferentialstatistics.

Documents

Study results

Abstract Flupirtine PASS 3300_Redacted