NON-INTERVENTIONAL RETROSPECTIVE EVALUATION OF TOLERABILITY AND EFFICACY OF TYPICAL ORAL LONG-ACTING WHO-STEP III OPIOID ANALGESICs UNDER REAL-WORLD CONDITIONS IN PATIENTS SUFFERING FROM (LOW) BACK PAIN AFTER FAILURE OF A PREVIOUS TREATMENT WITH EITHER NONOPIOID, MILD OR STRONG OPIOID ANALGESICS (123TOWHO3)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/32755
• EU PAS number:
  EUPAS32754
• Study ID:
  32755
• Official title and acronym:
  NON-INTERVENTIONAL RETROSPECTIVE EVALUATION OF TOLERABILITY AND EFFICACY OF TYPICAL ORAL LONG-ACTING WHO-STEP III OPIOID ANALGESICs UNDER REAL-WORLD CONDITIONS IN PATIENTS SUFFERING FROM (LOW) BACK PAIN AFTER FAILURE OF A PREVIOUS TREATMENT WITH EITHER NONOPIOID, MILD OR STRONG OPIOID ANALGESICS (123TOWHO3)
• 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 on the effectiveness, safety and tolerability of typical oral long-acting WHO-Step III opioid analgesics in patients with low back pain (LBP) who were previously treated with either nonopioids (group 1), mild (group 2) or strong opioid analgesics (group 3) 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: 30/11/2018

Actual: 30/11/2018

Study start date

Planned: 01/01/2019

Actual: 01/01/2019

Data analysis start date

Planned: 01/04/2019

Actual: 01/09/2019

Date of final study report

Planned: 30/06/2019

Actual: 12/12/2019

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