Efficacy and tolerability of the non-benzodiazepine antispasmodic methocarbamol for the short-term treatment of acute low back pain over 3 days - results of a patient-level pooled re-analysis of depersonalized data from two double-blind randomized placebo-controlled clinical trials evaluating oral and intravenous use. (METABO)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/50071
• EU PAS number:
  EUPAS50070
• Study ID:
  50071
• Official title and acronym:
  Efficacy and tolerability of the non-benzodiazepine antispasmodic methocarbamol for the short-term treatment of acute low back pain over 3 days - results of a patient-level pooled re-analysis of depersonalized data from two double-blind randomized placebo-controlled clinical trials evaluating oral and intravenous use. (METABO)
• DARWIN EU® study:
  No
• Study countries:
  Germany
• Study description:
  Patient-level pooled re-analysis of 72-hr. data from two double-blind, randomized, placebo-controlled trials evaluation the efficacy of the non-benzodiazepine antispasmodic methocarbamol (either given intravenously or orally) vs. matching placebo in adult patients with acute low back pain.
• Study status:
  Ongoing

Research institutions and networks

Institutions

O.Meany-MDPM

Study timelines

Date when funding contract was signed

Planned: 01/08/2022

Actual: 30/08/2022

Study start date

Planned: 10/10/2022

Actual: 25/11/2022

Data analysis start date

Planned: 24/10/2022

Actual: 01/12/2022

Date of final study report

Planned: 09/12/2022

Sources of funding

Pharmaceutical company and other private sector 

Other

More details on funding

Recordati, 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