A real world evidence study from Germany on the safety and efficacy of tapentadol and typical oral long-acting opioid analgesics in chronic low back pain patients (1o2toTAPoLAO)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/38333
• EU PAS number:
  EUPAS38332
• Study ID:
  38333
• Official title and acronym:
  A real world evidence study from Germany on the safety and efficacy of tapentadol and typical oral long-acting opioid analgesics in chronic low back pain patients (1o2toTAPoLAO)
• DARWIN EU® study:
  No
• Study countries:
  Germany
• Study description:
  Retrospective analysis of anonymized 12-week real-world data provided by the German Pain e-Registry (GPeR) on the effectiveness, safety and tolerability of tapentadol (TAP), an atypical WHO-III opioid) and typical oral long-acting opioid analgesics (LAO) in patients with chronic low back pain (LBP) under conditions of routine clinical practice.
• Study status:
  Finalised

Research institutions and networks

Institutions

O.Meany-MDPM

Study timelines

Date when funding contract was signed

Planned: 13/08/2020

Actual: 03/09/2020

Study start date

Planned: 14/08/2020

Actual: 04/09/2020

Data analysis start date

Planned: 24/08/2020

Actual: 14/09/2020

Date of final study report

Planned: 03/12/2020

Actual: 29/11/2020

Sources of funding

Pharmaceutical company and other private sector 

Other

More details on funding

Grünenthal, German Pain Association, 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