Effectiveness and tolerability of the THC:CBD oromucosal spray vs. dronabinol as add-on measure in patients with severe neuropathic pain: retrospective analysis of open-label real-world data provided by the German Pain e-Registry (SATIDRON)

Study identification

• EU PAS number:
  EUPAS33014
• Study ID:
  33015
• Official title and acronym:
  Effectiveness and tolerability of the THC:CBD oromucosal spray vs. dronabinol as add-on measure in patients with severe neuropathic pain: retrospective analysis of open-label real-world data provided by the German Pain e-Registry (SATIDRON)
• 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 an oromucosal spraycontaining delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD) vs. oral dronabinol, given as add-on treatment in patients with severe chronic neuropathic pain (SCNP) in routine clinical practice.
• Study status:
  Planned

Research institutions and networks

Institutions

Institute for Neurological Sciences (IFNAP)

Study timelines

Date when funding contract was signed

Planned:06/01/2020

Study start date

Planned:10/03/2017

Data analysis start date

Planned:13/01/2020

Date of final study report

Planned:30/04/2020

Sources of funding

Pharmaceutical company and other private sector 

Other

More details on funding

Almirall Hermal GmbH Germany, IFNAP - Institute of Neurological Sciences

Regulatory

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