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)

NCT02777970 Phase 4 COMPLETED Results posted

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.

Details

Lead sponsor	Menarini Group
Phase	Phase 4
Status	COMPLETED
Enrolment	654
Start date	2016-04
Completion	2017-02-14

Conditions

• Acute Pain

Interventions

• Tramadol Hydrochloride/Dexketoprofen Trometamol
• Tramadol Hydrochloride/Paracetamol
• Placebo

Primary outcomes

• TOTPAR6 (Total Pain Relief Over 6 Hours Post-dose) — 6 hours post-dose
  TOTPAR calculated as the weighted sum of the PAR scores, measured according to a 5-point VRS (Verbal Rating Scale) from 0=no relief to 4=complete relief, over 6 hours post-dose (TOTPAR6). The TOTPAR6 ranges from a minimum of 0 to a maximum of 24.

Countries

Hungary, Italy, Poland, Spain, United Kingdom