Effectiveness and tolerability of the THC:CBD oromucosal spray as add-on measure in patients with severe chronic pain: analysis of 12-week open-label real-world data provided by the German Pain e-Registry (ETORO-PAIN)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/25800
• EU PAS number:
  EUPAS25799
• Study ID:
  25800
• Official title and acronym:
  Effectiveness and tolerability of the THC:CBD oromucosal spray as add-on measure in patients with severe chronic pain: analysis of 12-week open-label real-world data provided by the German Pain e-Registry (ETORO-PAIN)
• DARWIN EU® study:
  No
• Study countries:
  Germany
• Study description:
  Cross-sectional retrospective analysis of anonymized real-world data provided by the German Pain e-Registry on the effectiveness, safety and tolerability of an oromucosal spray containing delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD), given as add-on treatment in patients with severe chronic pain (SCP) 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: 01/11/2017

Study start date

Planned: 10/03/2017

Data analysis start date

Planned: 29/01/2018

Date of interim report, if expected

Planned: 08/03/2018

Date of final study report

Planned: 15/06/2018

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