drugset / Trial / NCT01344720

Evaluation of the Efficacy and Tolerability of Etoricoxib Monotherapy Versus Combination Oxycodone-etoricoxib in Moderate to Severe Pain From Chronic Low Back Pain

NCT01344720

Phase 4 Unknown 250 enrolled Azienda Sanitaria Locale 4, Teramo
RandomizedParallel-groupSingle-blindTreatment

Summary

This randomized, single-blind, parallel-group study will investigate the efficacy and the tolerability of a combination treatment of etoricoxib (30 mg/day) plus controlled-release oxycodone (10 mg/day) compared with a titrated dose of etoricoxib up to 60mg/day as monotherapy , in patients with Chronic Low Back Pain (CLBP) who have not responded to the starting dose of Etoricoxib 30mg/day. A common clinical question is that is it better to increase the dose of the current monotherapy or to combine both treatments early on, in patients who do not respond to standard start doses of NSAIDs like etoricoxib.

Timeline

Start
2011-05
Primary completion
2011-05
Completion
2011-06

Drugs

EvaluationDrugModalityDoseRoute
Comparator Etoricoxib Small molecule 30 mg
Comparator Etoricoxib Small molecule 60 mg
Comparator Oxycodone Other / unclassified 5 mg

Indications

No indication recorded.