Study identification

PURI

https://redirect.ema.europa.eu/resource/38485

EU PAS number

EUPAS38484

Study ID

38485

Official title and acronym

Effectiveness and tolerability of high-dose methocarbamol vs. typical strong and long-acting opioidanalgesics (LAO) as add-on measure in patients with (low) back pain refractory to recommended 1st. line treatments: retrospective analysis of open-label real-world data provided by the German Pain e-Registry. (COMET)

DARWIN EU® study

No

Study countries

Germany

Study description

COMET is an exploratory non-interventional post-marketing, open-label, retrospective parallel-group, flexible-dose, comparative 4-week cohort study using depersonalized data of the German Pain e-Registry (GPeR) to assess the non-inferiority of an oral treatment with high-dose methocarbamol (Ortoton® forte, ORF) - a peripherally acting muscle relaxant - compared to typical oral long-acting opioid-analgesics (LAO) in adult patients with (low) back pain who are deemed to be in need of an alternative analgesic medication according to the mutual / shared decision of the responsible physician and the cLBP-patient after an insufficient pain relief in response to guideline-recommended systemic 1st-line treatments.

Study status

Ongoing
Research institutions and networks

Institutions

O.Meany-MDPM
First published:
01/02/2024
Institution

Contact details

Michael Ueberall

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:
Actual:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 
Other

More details on funding

Recordati Pharma, 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