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

NCT01904149 ↗

Phase 3 Completed 606 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 female patients presenting moderate to severe pain after a total/subtotal abdominal hysterectomy are eligible to be randomised provided that they experience moderate to severe pain on the day after surgery.

Timeline

Start: 2013-05
Primary completion: 2014-05
Completion: 2014-05

Outcome

Met primary endpoint

paper The study results confirmed the superiority of the combination over the single agents in terms of the primary endpoint (p <0.001). PMID 26801905 ↗

Publications

Results Moore RA, McQuay HJ, Tomaszewski J, Raba G, Tutunaru D, Lietuviete N, Galad J, Hagymasy L, Melka D, Kotarski J, Rechberger T, Fulesdi B, Nizzardo A, Guerrero-Bayon C, Cuadripani S, Piza-Vallespir B, Bertolotti M. Dexketoprofen/tramadol 25 mg/75 mg: randomised double-blind trial in moderate-to-severe acute pain after abdominal hysterectomy. BMC Anesthesiol. 2016 Jan 22;16:9. doi: 10.1186/s12871-016-0174-5.

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.