NCT01307020

Brief 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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
745

participants targeted

Target at P75+ for phase_2 pain

Timeline
Completed

Started Feb 2011

Shorter than P25 for phase_2 pain

Geographic Reach
6 countries

16 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

February 28, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 2, 2011

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

December 10, 2012

Completed
Last Updated

August 12, 2013

Status Verified

July 1, 2013

Enrollment Period

8 months

First QC Date

February 28, 2011

Results QC Date

October 11, 2012

Last Update Submit

July 31, 2013

Conditions

Pain

Keywords

Moderate to severe painPostoperative painAnalgesicsDexketoprofenTramadol

Outcome Measures

Primary Outcomes (1)

  • Percentage of Patients Achieving at Least 50 % of the Theoretical Maximum Total Pain Relief Score at 6 Hours Post-dosing.

    Pain relief is measured by a verbal rating scale (ranging from 0=none to 4=complete). Theoretical maximum TOTPAR at 6 hours is calculated by summing up the maximum score of analgesia which the patient can attribute at defined time points along 6 hour (maxTOTPAR6h= 24). Unit of measure is %

    6 hours

Secondary Outcomes (2)

  • Percentage of Patients Achieving at Least 50 % of the Theoretical Maximum Total Pain Relief Score at 4, 8 and 12 Hours Post-dosing.

    4, 8 and 12 hours

  • Percentage of Patients Using Rescue Medication at 6 Hours

    Baseline to 6 hours

Study Arms (10)

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Ibuprofen

ACTIVE COMPARATOR
Drug: Ibuprofen

TRAM.HCl high dose

ACTIVE COMPARATOR
Drug: Tramadol Hydrochloride

TRAM.HCl low dose

ACTIVE COMPARATOR
Drug: Tramadol Hydrochloride

DKP-TRIS high dose

ACTIVE COMPARATOR
Drug: Dexketoprofen Trometamol

DKP-TRIS low dose

ACTIVE COMPARATOR
Drug: Dexketoprofen Trometamol

DKP-TRIS low dose - TRAM.HCl low dose

EXPERIMENTAL
Drug: Dexketoprofen Trometamol + Tramadol Hydrochloride

DKP-TRIS low dose - TRAM.HCl high dose

EXPERIMENTAL
Drug: Dexketoprofen Trometamol + Tramadol Hydrochloride

DKP-TRIS high dose - TRAM.HCl low dose

EXPERIMENTAL
Drug: Dexketoprofen Trometamol + Tramadol Hydrochloride

DKP-TRIS high dose - TRAM.HCl high dose

EXPERIMENTAL
Drug: Dexketoprofen Trometamol + Tramadol Hydrochloride

Interventions

Dexketoprofen TrometamolDRUG

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

DKP-TRIS low dose
Tramadol HydrochlorideDRUG

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

TRAM.HCl low dose
IbuprofenDRUG

Ibuprofen 400 mg, oral film-coated table, once

Ibuprofen
PlaceboDRUG

Placebo, oral film-coated table, once

Placebo
Dexketoprofen Trometamol + Tramadol HydrochlorideDRUG

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

DKP-TRIS low dose - TRAM.HCl low dose

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

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

Greifswald, Mecklenburg-Vorpommern, 17475, Germany

Location

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

Kiel, Schleswig-Holstein, 24105, Germany

Location

Dr Tóth Bagi Zoltán Fogászati Rendeloje

Budapest, Budapest, 1052, Hungary

Location

Centro di Farmacologia Clinica per la Sperimentazione dei Farmaci

Pisa, Pisa, 56126, Italy

Location

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

Verona, Verona, 37134, Italy

Location

Gabinet Stomatologiczny Andrzej Wojtowicz AW Clinic

Warsaw, Masovian Voivodeship, 00-852, Poland

Location

Dental Service spólka jawna

Warsaw, Masovian Voivodeship, 02-791, Poland

Location

Hospital Médico Quirúrgico de Conxo

Santiago de Compostela, A Coruña, 15706, Spain

Location

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

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Universidad Complutense de Madrid

Madrid, Madrid, 28040, Spain

Location

Departamento de Estomatología, Facultad de Odontología. Universidad de Sevilla

Seville, Sevilla, 41009, Spain

Location

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

Valencia, Valencia, 046010, Spain

Location

Hospital General Universitario de Valencia

Valencia, Valencia, 46014, Spain

Location

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

Birmingham, England, B4 6 NN, United Kingdom

Location

University Dental School Manchester

Manchester, England, M15 6FH, United Kingdom

Location

University Dental Hospital

Cardiff, Wales, CF14 4 XY, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 26123824DERIVED

MeSH Terms

Conditions

PainPain, Postoperative

Interventions

dexketoprofen trometamolTramadolIbuprofen

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic Processes

Intervention Hierarchy (Ancestors)

CyclohexanolsHexanolsFatty AlcoholsAlcoholsOrganic ChemicalsDimethylaminesMethylaminesAminesLipidsPhenylpropionatesAcids, CarbocyclicCarboxylic Acids

Results Point of Contact

Title
Dr Angela Capriati, Corporate Clinical Research Director
Organization
Menarini Ricerche S.p.A.
acapriati@menarini-ricerche.it
+39 055 5680 9933

Study Officials

  • 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)

    STUDY CHAIR

  • 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 CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2011

First Posted

March 2, 2011

Study Start

February 1, 2011

Primary Completion

October 1, 2011

Study Completion

October 1, 2011

Last Updated

August 12, 2013

Results First Posted

December 10, 2012

Record last verified: 2013-07

Locations

PL(2)ES(6)IT(2)DE(2)HU(1)GB(3)