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

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 male and female patients presenting moderate to severe pain after an elective primary hip arthroplasty are eligible to be randomised provided that they experience moderate to severe pain on the day after surgery.

Conditions

• Acute Pain

Interventions

DRUG

Placebo

Placebo single oral dose (first 8 hours)

DRUG

Tramadol-single dose

Tramadol single oral dose (first 8 hours)

DRUG

Dexketoprofen-single dose

Dexketoprofen single oral dose (first 8 hours)

DRUG

Dexketoprofen/Tramadol-single dose

Dexketoprofen/Tramadol oral single dose (first 8 hours)

DRUG

Tramadol-multiple doses

Tramadol multiple oral doses t.i.d. for 5 days (total 12 doses)

DRUG

Dexketoprofen-multiple doses

Dexketoprofen multiple oral doses t.i.d. for 5 days (total 12 doses)

DRUG

Dexketoprofen/Tramadol-multiple doses

Dexketoprofen/Tramadol multiple oral doses t.i.d. for 5 days (total 12 doses)

Sponsors & Collaborators

• Menarini Group

  lead INDUSTRY

Principal Investigators

• Andrew Moore, Professor · Pain Research & Nuffield Department of Anaesthetics - University of Oxford

• Henry J McQuay, Professor · Balliol College Oxford

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-04-30

Primary Completion

2014-02-28

Completion

2014-02-28

Countries

• Czechia
• Germany
• Hungary
• Latvia
• Lithuania
• Poland
• Serbia
• Spain
• Taiwan
• Ukraine

Study Locations