Analgesic Effect of Different Combinations of Dexketoprofen Trometamol With Tramadol Hydrochloride in a Model of Moderate to Severe Pain

Phase 2 Completed 745 enrolled Menarini Group PRA Health Sciences · collab

RandomizedParallel-groupTriple-blindTreatment

Summary

The purpose of this study is to evaluate the analgesic efficacy of Dexketoprofen Trometamol and Tramadol Hydrochloride given in combinations and the analgesic efficacy of each single component in comparison to placebo on moderate to severe pain following impacted third mandibular molar tooth extraction. Ibuprofen will be used as an active control to validate the pain model.

Timeline

Start: 2011-02
Primary completion: 2011-10
Completion: 2011-10

Publications

Moore RA, Gay-Escoda C, Figueiredo R, Toth-Bagi Z, Dietrich T, Milleri S, Torres-Lagares D, Hill CM, Garcia-Garcia A, Coulthard P, Wojtowicz A, Matenko D, Penarrocha-Diago M, Cuadripani S, Piza-Vallespir B, Guerrero-Bayon C, Bertolotti M, Contini MP, Scartoni S, Nizzardo A, Capriati A, Maggi CA. Dexketoprofen/tramadol: randomised double-blind trial and confirmation of empirical theory of combination analgesics in acute pain. J Headache Pain. 2015;16:541. doi: 10.1186/s10194-015-0541-5. Epub 2015 Jun 27.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Dexketoprofen Trometamol	Small molecule	12.5 mg	Oral
Subject	Dexketoprofen Trometamol	Small molecule	25 mg	Oral
Comparator	Ibuprofen	Small molecule	400 mg	Oral
Subject	Tramadol	Other / unclassified	37.5 mg	Oral
Subject	Tramadol	Other / unclassified	75 mg	Oral

Indications

No indication recorded.