Oral Treatment for Orthopaedic Post-operative Pain With Dexketoprofen Trometamol and Tramadol Hydrochloride

NCT01902134 ↗

Phase 3 Completed 641 enrolled Menarini Group

RandomizedParallel-groupTriple-blindTreatment

Summary

This study aims to evaluate the analgesic efficacy of single and repeated doses of fixed combination of dexketoprofen trometamol (DKP) and tramadol hydrochloride (TRAM) in comparison to the single agents (and placebo for the single dose phase only) Approximately 600 male and female patients presenting moderate to severe pain after an elective primary hip arthroplasty are eligible to be randomised provided that they experience moderate to severe pain on the day after surgery.

Timeline

Start: 2013-04
Primary completion: 2014-02
Completion: 2014-02

Publications

Results McQuay HJ, Moore RA, Berta A, Gainutdinovs O, Fulesdi B, Porvaneckas N, Petronis S, Mitkovic M, Bucsi L, Samson L, Zegunis V, Ankin ML, Bertolotti M, Piza-Vallespir B, Cuadripani S, Contini MP, Nizzardo A. Randomized clinical trial of dexketoprofen/tramadol 25 mg/75 mg in moderate-to-severe pain after total hip arthroplasty. Br J Anaesth. 2016 Feb;116(2):269-76. doi: 10.1093/bja/aev457.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Dexketoprofen	Small molecule	25 mg	Oral
Subject	Tramadol	Other / unclassified	75 mg	Oral
Subject	Tramadol	Other / unclassified	100 mg	Oral

Indications

No indication recorded.