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 (DEX-TRA 02)

NCT01307020 Phase 2 COMPLETED Results posted

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.

Details

Lead sponsor	Menarini Group
Phase	Phase 2
Status	COMPLETED
Enrolment	745
Start date	2011-02
Completion	2011-10

Conditions

• Pain

Interventions

• Dexketoprofen Trometamol
• Dexketoprofen Trometamol
• Tramadol Hydrochloride
• Tramadol Hydrochloride
• Ibuprofen
• Placebo
• Dexketoprofen Trometamol + Tramadol Hydrochloride
• Dexketoprofen Trometamol + Tramadol Hydrochloride
• Dexketoprofen Trometamol + Tramadol Hydrochloride
• Dexketoprofen Trometamol + Tramadol Hydrochloride

Primary outcomes

• Percentage of Patients Achieving at Least 50 % of the Theoretical Maximum Total Pain Relief Score at 6 Hours Post-dosing. — 6 hours
  Pain relief is measured by a verbal rating scale (ranging from 0=none to 4=complete). Theoretical maximum TOTPAR at 6 hours is calculated by summing up the maximum score of analgesia which the patient can attribute at defined time points along 6 hour (maxTOTPAR6h= 24). Unit of measure is %

Countries

Germany, Hungary, Italy, Poland, Spain, United Kingdom