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

NCT ID: NCT01307020

Last Updated: 2013-08-12

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

745 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2011-10-31

Brief Summary

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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.

Detailed Description

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The aim of this study is to develop a combination of Dexketoprofen Trometamol (DKP.TRIS) and Tramadol Hydrochloride (TRAM.HCl) for the treatment of acute moderate to severe pain, based on the rationale that more than one drug is necessary in most patients suffering of acute and chronic pain, particularly of moderate to severe intensity.

DKP.TRIS and TRAM.HCl have different mechanisms of action, therefore their combination is expect to result in an additive or synergistic analgesia, thus allowing a decrease in the required doses of the individual agents, and consequently a reduced risk of adverse events In this study, patients who present moderate to severe pain after impacted third mandibular molar tooth extraction will be randomised to a total of 10 treatment arms including 4 combinations of DKP.TRIS + TRAM.HCl, the four corresponding single treatments, placebo and ibuprofen. Treatment administration will be followed by a 24-hour pain and analgesic effect assessment.

Conditions

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Pain

Keywords

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Moderate to severe pain Postoperative pain Analgesics Dexketoprofen Tramadol

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo, oral film-coated table, once

Ibuprofen

Group Type ACTIVE_COMPARATOR

Ibuprofen

Intervention Type DRUG

Ibuprofen 400 mg, oral film-coated table, once

TRAM.HCl high dose

Group Type ACTIVE_COMPARATOR

Tramadol Hydrochloride

Intervention Type DRUG

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

TRAM.HCl low dose

Group Type ACTIVE_COMPARATOR

Tramadol Hydrochloride

Intervention Type DRUG

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

DKP-TRIS high dose

Group Type ACTIVE_COMPARATOR

Dexketoprofen Trometamol

Intervention Type DRUG

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

DKP-TRIS low dose

Group Type ACTIVE_COMPARATOR

Dexketoprofen Trometamol

Intervention Type DRUG

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

DKP-TRIS low dose - TRAM.HCl low dose

Group Type EXPERIMENTAL

Dexketoprofen Trometamol + Tramadol Hydrochloride

Intervention Type DRUG

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

DKP-TRIS low dose - TRAM.HCl high dose

Group Type EXPERIMENTAL

Dexketoprofen Trometamol + Tramadol Hydrochloride

Intervention Type DRUG

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

DKP-TRIS high dose - TRAM.HCl low dose

Group Type EXPERIMENTAL

Dexketoprofen Trometamol + Tramadol Hydrochloride

Intervention Type DRUG

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

DKP-TRIS high dose - TRAM.HCl high dose

Group Type EXPERIMENTAL

Dexketoprofen Trometamol + Tramadol Hydrochloride

Intervention Type DRUG

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

Interventions

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Dexketoprofen Trometamol

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

Intervention Type DRUG

Dexketoprofen Trometamol

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

Intervention Type DRUG

Tramadol Hydrochloride

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

Intervention Type DRUG

Tramadol Hydrochloride

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

Intervention Type DRUG

Ibuprofen

Ibuprofen 400 mg, oral film-coated table, once

Intervention Type DRUG

Placebo

Placebo, oral film-coated table, once

Intervention Type DRUG

Dexketoprofen Trometamol + Tramadol Hydrochloride

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

Intervention Type DRUG

Dexketoprofen Trometamol + Tramadol Hydrochloride

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

Intervention Type DRUG

Dexketoprofen Trometamol + Tramadol Hydrochloride

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

Intervention Type DRUG

Dexketoprofen Trometamol + Tramadol Hydrochloride

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Patients meeting ALL the following criteria will be eligible for entry into the study:

* Male or female patients aged 18 to 70 years old. Females participating in the study must be either: of non-childbearing potential, or willing to use a highly effective contraceptive method.
* Scheduled for outpatient surgical extraction -under local anaesthesia- of third mandibular molar teeth, with at least one of which is fully or partially impacted in the mandible requiring bone manipulation.
* Normal physical examination or without clinically relevant abnormalities.

At randomisation (after surgery):

No intake of analgesics (including prescription and over the counter drugs) within 24h prior to the surgery.

* No complication during the surgery, duration of surgery \< 1 hour and not requiring re-anaesthesia.
* Patients experiencing pain of moderate or higher intensity in the first four hours after the end of surgery.

Exclusion Criteria

* History of allergy or hypersensitivity to NSAIDs, opioids or acetyl salicylic acid.
* History of asthma, bronchospasm, acute rhinitis, nasal polyps, urticaria or angioneurotic oedema.
* History of peptic ulcer, gastrointestinal disorders by NSAIDs, gastrointestinal bleeding or other active bleedings.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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PRA Health Sciences

INDUSTRY

Sponsor Role collaborator

Menarini Group

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Cosme Gay-Escoda, Professor

Role: STUDY_CHAIR

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

Role: STUDY_CHAIR

Pain Research & Nuffield Division of Anaesthesics, Department of Clinical Neurosciences, University of Oxford. The Churchill, Oxford OX3 7LJ (United Kingdom)

Locations

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Klinik und Polickinik für Mund-Kiefer-Gesichtschirurgie/Plastische Operationen Greifswald

Greifswald, Mecklenburg-Vorpommern, Germany

Site Status

Klinik für Mund-, Kiefer- und Gesichtschirurgie, Universitätsklinikum Schleswig Holstein, Campus Kiel

Kiel, Schleswig-Holstein, Germany

Site Status

Dr Tóth Bagi Zoltán Fogászati Rendeloje

Budapest, Budapest, Hungary

Site Status

Centro di Farmacologia Clinica per la Sperimentazione dei Farmaci

Pisa, Pisa, Italy

Site Status

Centro di Ricerche Cliniche di Verona Srl. Policlinico G.B.Rossi

Verona, Verona, Italy

Site Status

Gabinet Stomatologiczny Andrzej Wojtowicz AW Clinic

Warsaw, Masovian Voivodeship, Poland

Site Status

Dental Service spólka jawna

Warsaw, Masovian Voivodeship, Poland

Site Status

Hospital Médico Quirúrgico de Conxo

Santiago de Compostela, A Coruña, Spain

Site Status

Facultad de Odontología. Departamento de Cirugía Bucal y Maxilofacial, University of Barcelona - Bellvitge Institute for Biomedical Research (IDIBELL)

L'Hospitalet de Llobregat, Barcelona, Spain

Site Status

Universidad Complutense de Madrid

Madrid, Madrid, Spain

Site Status

Departamento de Estomatología, Facultad de Odontología. Universidad de Sevilla

Seville, Sevilla, Spain

Site Status

Departament d'Estomatologia, Clínica Odontològica, Universidad de Valencia - Fundació Lluís Alcanyís

Valencia, Valencia, Spain

Site Status

Hospital General Universitario de Valencia

Valencia, Valencia, Spain

Site Status

The School of Dentistry, College of Medical and Dental Sciences, University of Birmingham

Birmingham, England, United Kingdom

Site Status

University Dental School Manchester

Manchester, England, United Kingdom

Site Status

University Dental Hospital

Cardiff, Wales, United Kingdom

Site Status

Countries

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Germany Hungary Italy Poland Spain United Kingdom

References

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Moore RA, Gay-Escoda C, Figueiredo R, Toth-Bagi Z, Dietrich T, Milleri S, Torres-Lagares D, Hill CM, Garcia-Garcia A, Coulthard P, Wojtowicz A, Matenko D, Penarrocha-Diago M, Cuadripani S, Piza-Vallespir B, Guerrero-Bayon C, Bertolotti M, Contini MP, Scartoni S, Nizzardo A, Capriati A, Maggi CA. Dexketoprofen/tramadol: randomised double-blind trial and confirmation of empirical theory of combination analgesics in acute pain. J Headache Pain. 2015;16:541. doi: 10.1186/s10194-015-0541-5. Epub 2015 Jun 27.

Reference Type DERIVED
PMID: 26123824 (View on PubMed)

Other Identifiers

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2010-022798-32

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

DEX-TRA 02

Identifier Type: -

Identifier Source: org_study_id