Clinical Trial: Tramadol Hydrochloride and Dexketoprofen Trometamol for the Oral Treatment of Moderate to Severe Acute Pain Following Removal of Impacted Lower Third Molar

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Analgesic Efficacy of Oral Dexketoprofen Trometamol/Tramadol Hydrochloride Versus Tramadol Hydrochloride/Paracetamol: a Randomised, Double-blind, Placebo and Active-controlled, Parallel Group Study in

Brief Summary: 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.

Detailed Summary:

The present phase IV study is a randomised, double-blind, placebo and active-controlled, parallel group study in moderate to severe acute pain after removal of impacted lower third molar.

In this single-dose clinical trial patients are randomized to the following 3 treatment arms in a 2:2:1 ratio:

  • TRAM.HCL/DKP.TRIS
  • Paracetamol/TRAM.HCL
  • Placebo.

Sponsor: Menarini Group

Current Primary Outcome: TOTPAR6 (Total Pain Relief) [ Time Frame: 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).


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • % of patients achieving 50% of max TOTPAR [ Time Frame: 8 hours post-dose ]
    Percentage of patients achieving at least 50% of maximum TOTPAR over 8 hours post-dose.
  • % of patients achieving 30% of PI (Pain Intensity) reduction over 8 hours post-dose [ Time Frame: 8 hours post-dose ]
    Percentage of patients who achieved at least 30% of PI reduction versus baseline at each pre-specified time point over the 8-hour post-dose period.
  • Time to confirmed FPPAR (First Perceptible Pain Relief) [ Time Frame: 2 hours post-dose ]
    Time to confirmed FPPAR (time to onset of analgesia) - i.e. time to FPPAR if confirmed by experiencing Meaningful Pain Relief (MPAR)
  • % of patients requiring RM [ Time Frame: 8 hours post-dose ]
    Percentage of patients who required RM within the first over 8 hours post-dose.
  • PGE (Patient Global Evaluation) [ Time Frame: 8 hours postdose ]
    PGE of the study medication (measured according to a five-point VRS from 1 = poor to 5 = excellent) at 8 hours post-dose or whenever the patient uses Rescue Medication (RM).


Original Secondary Outcome: Same as current

Information By: Menarini Group

Dates:
Date Received: May 13, 2016
Date Started: April 2016
Date Completion: April 2017
Last Updated: February 9, 2017
Last Verified: February 2017