NCT01904149

Oral Treatment for Gynaecological Post-operative Pain With Dexketoprofen Trometamol and Tramadol Hydrochloride

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 606 (actual)
• Sponsor: Menarini Group · Industry
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

In this clinical trial patients were randomized to the described 6 treatment arms, where each arm define the treatment to be received in the first single dose phase (lasting 8 hours after the 1st treatment intake) and in the subsequent multiple-dose phase (lasting from the second treatment intake up to the 8 hours after the last intake). Namely: * DKP/TRAM followed by DKP/TRAM; * DKP followed by DKP; * TRAM followed by TRAM; * placebo followed by DKP; * placebo followed by TRAM; * placebo followed by DKP/TRAM; The analyses of endpoints pertinent to the single dose phase were performed combining all the 3 treatment arms including placebo into one group, which resulted in the following 4 analysis groups: DKP/TRAM, DEXKETOPROFEN, TRAMADOL, and Placebo. The analysis of endpoints pertinent to the multiple dose phase were performed combining the treatment arms including the same active treatment, which resulted in the following 3 analysis groups: DKP/TRAM, DEXKETOPROFEN, and TRAMADOL.

Conditions

• Acute Pain

Interventions

Type	Name	Description
DRUG	Placebo	Placebo single oral dose (first 8 hours)
DRUG	Dexketoprofen-single dose	Dexketoprofen single oral dose (first 8 hours)
DRUG	Tramadol-single dose	Tramadol single oral dose (first 8 hours)
DRUG	Dexketoprofen/Tramadol-single dose	Dexketoprofen/Tramadol single oral dose (first 8 hours)
DRUG	Dexketoprofen-multiple doses	Dexketoprofen multiple oral doses t.i.d. for 3 days (total 6 doses)
DRUG	Tramadol-multiple doses	Tramadol multiple oral doses t.i.d. for 3 days (total 6 doses)
DRUG	Dexketoprofen/Tramadol-multiple doses	Dexketoprofen/Tramadol multiple oral doses t.i.d. for 3 days (total 6 doses)

Timeline

• Start date: 2013-05-01
• Primary completion: 2014-05-01
• Completion: 2014-05-01
• First posted: 2013-07-22
• Last updated: 2016-04-01
• Results posted: 2015-04-01

Locations

28 sites across 8 countries: Hungary, Latvia, Lithuania, Poland, Romania, Russia, Slovakia, Spain