NCT02777970

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

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)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 654 (actual)
• Sponsor: Menarini Group · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Acute Pain

Interventions

Type	Name	Description
DRUG	Tramadol Hydrochloride/Dexketoprofen Trometamol
DRUG	Tramadol Hydrochloride/Paracetamol
DRUG	Placebo

Timeline

• Start date: 2016-04-01
• Primary completion: 2017-02-14
• Completion: 2017-02-14
• First posted: 2016-05-19
• Last updated: 2021-03-24
• Results posted: 2021-03-24

Locations

18 sites across 5 countries: Hungary, Italy, Poland, Spain, United Kingdom