Pridinol vs. nsaids - efficacy/tolerability in acute (low) back pain. A propensity-score matched, comparative 2-cohort, 4-week real world evidence analysis of depersonalized data from the German Pain e-Registry in patients refractory to self-medication. (Providence)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/49719
• EU PAS number:
  EUPAS49718
• Study ID:
  49719
• Official title and acronym:
  Pridinol vs. nsaids - efficacy/tolerability in acute (low) back pain. A propensity-score matched, comparative 2-cohort, 4-week real world evidence analysis of depersonalized data from the German Pain e-Registry in patients refractory to self-medication. (Providence)
• DARWIN EU® study:
  No
• Study countries:
  Germany
• Study description:
  Retrospective analysis of anonymized 4-week real-world data provided by the German Pain e-Registry (GPeR) on the effectiveness, safety and tolerability of pridinol (PRI), a muscarinic acetylcholine receptor antagonist with antispasmodic effects and traditional nonsteroidal antiinflammatory agents (NSAIDs) in patients with acute (low) back pain (LBP) refractory to self-medication.
• Study status:
  Finalised

Research institutions and networks

Institutions

O.Meany-MDPM

Study timelines

Date when funding contract was signed

Planned: 04/07/2022

Actual: 06/07/2022

Study start date

Planned: 01/07/2022

Actual: 18/07/2022

Data analysis start date

Planned: 18/07/2022

Actual: 25/07/2022

Date of final study report

Planned: 31/10/2022

Actual: 09/11/2022

Sources of funding

Pharmaceutical company and other private sector 

Other

More details on funding

Strathmann, 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