Longitudinal analysis of the efficacy and tolerability of dronabinol use in patients with severe ± chronic pain – a retrospective analysis of open-label real-world data provided by the German Pain e-Registry. (ReDroPain)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation

  Effectiveness study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Cohort

  Cross-sectional

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  DRONABINOL
• Medical condition to be studied:
  Musculoskeletal pain

Population studied

• 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:
  1145

Study design details

• Main study objective:
  Main objective of this analysis is to gain further insight into the differential effects and thebenefit-risk profile (BRP) of dronabinol given add-on to patients withelsewhere refractory severe chronic 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 four different criteria (at least 50% improvement of pain, pain-related disabilities in daily life, quality-of-life,depression, sleep, each at end of observation 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 12-week routine/open-label data of the German Paine-Registry (GPR) on adult SCP patients, in whom a treatment with dronabinol has beeninitiated in compliance with the current German prescribing regulations between March 10th and December 31st, 2018. 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).