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 identification

• PURI:
  https://redirect.ema.europa.eu/resource/35351
• EU PAS number:
  EUPAS35350
• Study ID:
  35351
• Official title and acronym:
  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)
• DARWIN EU® study:
  No
• Study countries:
  Germany
• Study description:
  Cross-sectional retrospective analysis of anonymized real-world data provided by theGerman Pain e-Registry on the effectiveness, safety and tolerability of oral dronabinol given as add-on treatment in patients with severe chronic pain (SCP) in routine clinical practice.
• Study status:
  Planned

Research institutions and networks

Institutions

O.Meany-MDPM

Study timelines

Date when funding contract was signed

Planned: 13/12/2019

Study start date

Planned: 02/01/2020

Data analysis start date

Planned: 03/02/2020

Date of interim report, if expected

Planned: 28/02/2020

Date of final study report

Planned: 30/04/2020

Sources of funding

Pharmaceutical company and other private sector 

Other

More details on funding

Canada Inc. DBA Spectrum Therapeutics, O.Meany-MDPM GmbH

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable