A Randomized, Double-blind, Placebo and Active-controlled, Parallel-group Study to Evaluate the Analgesic Efficacy and Safety of Dexketoprofen Trometamol and Tramadol Hydrochloride Oral Fixed Combination on Moderate to Severe Acute Pain Following Abdominal Hysterectomy (DAVID lap)

NCT01904149 Phase 3 COMPLETED Results posted

This study aims to evaluate the analgesic efficacy of single and repeated doses of fixed combination of dexketoprofen trometamol (DKP) and tramadol hydrochloride (TRAM) in comparison to the single agents (and placebo for the single dose phase only). Approximately 600 female patients presenting moderate to severe pain after a total/subtotal abdominal hysterectomy are eligible to be randomised provided that they experience moderate to severe pain on the day after surgery.

Details

Lead sponsor	Menarini Group
Phase	Phase 3
Status	COMPLETED
Enrolment	606
Start date	2013-05
Completion	2014-05

Conditions

• Acute Pain

Interventions

• Placebo
• Dexketoprofen-single dose
• Tramadol-single dose
• Dexketoprofen/Tramadol-single dose
• Dexketoprofen-multiple doses
• Tramadol-multiple doses
• Dexketoprofen/Tramadol-multiple doses

Primary outcomes

• SPID8 (Sum of Pain Intensity Differences Over 8 Hours) — over 8 hours after the first dose
  Sum of Pain Intensity Differences calculated as the weighted sum of the PI-VAS differences over 8 hour period. PI-VAS corresponds to the pain intensity measured by a 0-100 visual analogue scale (0=no pain to 100=worst pain imaginable) which was measured at 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, and 8h after the first dose. A higher value in SPID indicates greater pain relief. The analysis was performed combining all randomization arms including placebo into one group, which resulted in the following 4 analysis groups: DKP/TRAM, DEXKETOPROFEN, TRAMADOL, and Placebo.

Countries

Hungary, Latvia, Lithuania, Poland, Romania, Russia, Slovakia, Spain