Analgesic Effect of Different Combinations of Dexketoprofen Trometamol With Tramadol Hydrochloride in a Model of Moderate to Severe Pain

Summary

The purpose of this study is to evaluate the analgesic efficacy of Dexketoprofen Trometamol and Tramadol Hydrochloride given in combinations and the analgesic efficacy of each single component in comparison to placebo on moderate to severe pain following impacted third mandibular molar tooth extraction. Ibuprofen will be used as an active control to validate the pain model.

Conditions

• Pain

Interventions

DRUG

Dexketoprofen Trometamol

Dexketoprofen Trometamol low dose, oral film-coated table, once

DRUG

Dexketoprofen Trometamol

Dexketoprofen Trometamol high dose, oral film-coated table, once

DRUG

Tramadol Hydrochloride

Tramadol Hydrochloride low dose, oral film-coated table, once

DRUG

Tramadol Hydrochloride

Tramadol Hydrochloride high dose, oral film-coated table, once

DRUG

Ibuprofen

Ibuprofen 400 mg, oral film-coated table, once

DRUG

Placebo

Placebo, oral film-coated table, once

DRUG

Dexketoprofen Trometamol + Tramadol Hydrochloride

DKP-TRIS low dose - TRAM.HCl low dose, oral film-coated table, once

DRUG

Dexketoprofen Trometamol + Tramadol Hydrochloride

DKP-TRIS low dose - TRAM.HCl high dose, oral film-coated table, once

DRUG

Dexketoprofen Trometamol + Tramadol Hydrochloride

DKP-TRIS high dose - TRAM.HCl low dose, oral film-coated tablet, once

DRUG

Dexketoprofen Trometamol + Tramadol Hydrochloride

DKP-TRIS high dose - TRAM.HCl high dose, oral film-coated tablet, once

Sponsors & Collaborators

• PRA Health Sciences

  collaborator INDUSTRY

• Menarini Group

  lead INDUSTRY

Principal Investigators

• Cosme Gay-Escoda, Professor · Department of Oral and Maxillofacial Surgery, School of Dentistry, University of Barcelona - Bellvitge Institute for Biomedical Research (IDIBELL) 08907 Hospitalet de Llobregat, Barcelona (Spain)

• R Andrew Moore, Professor · Pain Research & Nuffield Division of Anaesthesics, Department of Clinical Neurosciences, University of Oxford. The Churchill, Oxford OX3 7LJ (United Kingdom)

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-02-28

Primary Completion

2011-10-31

Completion

2011-10-31

Countries

• Germany
• Hungary
• Italy
• Poland
• Spain
• United Kingdom

Study Locations