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Tramadol Hydrochloride and Dexketoprofen Trometamol for the Oral Treatment of Moderate to Severe Acute Pain Following Removal of Impacted Lower Third Molar — DAVID  

Acute Pain Clinical Trial

Official title:
Analgesic Efficacy of Oral Dexketoprofen Trometamol/Tramadol Hydrochloride Versus Tramadol Hydrochloride/Paracetamol: a Randomised, Double-blind, Placebo and Active-controlled, Parallel Group Study in Moderate to Severe Acute Pain After Removal of Impacted Lower Third Molar (Dexketoprofen Analgesic eVolution wIth tramaDol- DAVID Study)

Clinical Trial Summary

The study is aimed to evaluate the analgesic efficacy of TRAM.HCl/DKP.TRIS 75mg/25mg oral fixed drug combination in comparison with TRAM.HCl /paracetamol 75mg/650mg in the treatment of moderate to severe acute pain.

Clinical Trial Description

The present phase IV study is a randomised, double-blind, placebo and active-controlled, parallel group study in moderate to severe acute pain after removal of impacted lower third molar. In this single-dose clinical trial patients are randomized to the following 3 treatment arms in a 2:2:1 ratio: - TRAM.HCL/DKP.TRIS - Paracetamol/TRAM.HCL - Placebo. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02777970
Study type Interventional
Source Menarini Group
Contact
Status Completed
Phase Phase 4
Start date April 2016
Completion date February 14, 2017
View Details
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