NCT01307020

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

Double-blind, Randomised, Placebo and Active Controlled, Parallel Group Study to Evaluate the Analgesic Effect of a Single Oral Administration of Four Different Combination Doses of DKP.TRIS With TRAM.HCL in Comparison With the Single Agents, on Moderate to Severe Pain Following Impacted Third Mandibular Molar Tooth Extraction

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 745 (actual)
• Sponsor: Menarini Group · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The aim of this study is to develop a combination of Dexketoprofen Trometamol (DKP.TRIS) and Tramadol Hydrochloride (TRAM.HCl) for the treatment of acute moderate to severe pain, based on the rationale that more than one drug is necessary in most patients suffering of acute and chronic pain, particularly of moderate to severe intensity. DKP.TRIS and TRAM.HCl have different mechanisms of action, therefore their combination is expect to result in an additive or synergistic analgesia, thus allowing a decrease in the required doses of the individual agents, and consequently a reduced risk of adverse events In this study, patients who present moderate to severe pain after impacted third mandibular molar tooth extraction will be randomised to a total of 10 treatment arms including 4 combinations of DKP.TRIS + TRAM.HCl, the four corresponding single treatments, placebo and ibuprofen. Treatment administration will be followed by a 24-hour pain and analgesic effect assessment.

Conditions

• Pain

Interventions

Type	Name	Description
DRUG	Dexketoprofen Trometamol	Dexketoprofen Trometamol low dose, oral film-coated table, once
DRUG	Dexketoprofen Trometamol	Dexketoprofen Trometamol high dose, oral film-coated table, once
DRUG	Tramadol Hydrochloride	Tramadol Hydrochloride low dose, oral film-coated table, once
DRUG	Tramadol Hydrochloride	Tramadol Hydrochloride high dose, oral film-coated table, once
DRUG	Ibuprofen	Ibuprofen 400 mg, oral film-coated table, once
DRUG	Placebo	Placebo, oral film-coated table, once
DRUG	Dexketoprofen Trometamol + Tramadol Hydrochloride	DKP-TRIS low dose - TRAM.HCl low dose, oral film-coated table, once
DRUG	Dexketoprofen Trometamol + Tramadol Hydrochloride	DKP-TRIS low dose - TRAM.HCl high dose, oral film-coated table, once
DRUG	Dexketoprofen Trometamol + Tramadol Hydrochloride	DKP-TRIS high dose - TRAM.HCl low dose, oral film-coated tablet, once
DRUG	Dexketoprofen Trometamol + Tramadol Hydrochloride	DKP-TRIS high dose - TRAM.HCl high dose, oral film-coated tablet, once

Timeline

• Start date: 2011-02-01
• Primary completion: 2011-10-01
• Completion: 2011-10-01
• First posted: 2011-03-02
• Last updated: 2013-08-12
• Results posted: 2012-12-10

Locations

16 sites across 6 countries: Germany, Hungary, Italy, Poland, Spain, United Kingdom