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

NCT ID: NCT02777970

Last Updated: 2021-03-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 654 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2017-02-14

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 Description

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.

Conditions

Acute Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Tramadol/Dexketoprofen

Tramadol Hydrochloride/Dexketoprofen Trometamol 75mg/25mg film-coated tablet oral single dose;

Placebo matching Tramadol Hydrochloride/Paracetamol 75 mg/650mg, as 2 x [37.5mg/325mg] film-coated tablets, oral single dose.

Group Type: EXPERIMENTAL

Tramadol Hydrochloride/Dexketoprofen Trometamol

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Tramadol/Paracetamol

Tramadol Hydrochloride/Paracetamol 75 mg/650 mg, as 2 x [37.5mg/325mg] film-coated tablets, oral single dose;

Placebo matching Tramadol Hydrochloride/Dexketoprofen Trometamol 75mg/25mg film-coated tablet oral single dose.

.

Group Type: ACTIVE_COMPARATOR

Tramadol Hydrochloride/Paracetamol

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Placebo

Placebo matching one film-coated tablet of Tramadol Hydrochloride/Dexketoprofen Trometamol 75mg/25mg oral single dose;

Placebo matching two film-coated tablets of Tramadol Hydrochloride/Paracetamol 37.5mg/325mg oral single dose.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Interventions

Tramadol Hydrochloride/Dexketoprofen Trometamol

Intervention Type: DRUG

Tramadol Hydrochloride/Paracetamol

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Male or female patients aged more than 18 years. Females participating in the study must be either non-childbearing potential or routinely using an effective method of birth control resulting in a low failure rate.
• Scheduled for outpatient surgical extraction -under local anaesthesia of lower third molar teeth, with at least one partially impacted in the mandible requiring bone manipulation.
• Pain of at least moderate intensity in the first 4 hours after the end of surgery (NRS score ≥ 4).

Exclusion Criteria

• History of allergy or hypersensitivity to the study treatments, RM or to any other NSAIDs, opioids and acetyl salicylic acid.
• History of peptic ulcer, gastrointestinal disorders by NSAIDs or gastrointestinal bleeding or other active bleedings.
• History of any illness or condition that, in the opinion of the Investigator might pose a risk to the patient or confound the efficacy and safety results of the study.
• Patients using and not suitable for withdrawing the prohibited medications specified in the protocol.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Menarini Group

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Dr. Tóth Bagi Zoltán Fogászati Rendeloje

Budapest, , Hungary

OralMed Studio Fogászati és Szájsebészeti Kft.

Budapest, , Hungary

Szegedi Tudományegyetem

Szeged, , Hungary

Ospedale Civile San Salvatore di L'Aquila

L’Aquila, , Italy

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, , Italy

Azienda Ospedaliero-Universitaria Pisana

Pisa, , Italy

Azienda Ospedaliera Universitaria Integrata

Verona, , Italy

Ars-Dent

Bialystok, , Poland

Gabinet Stomatologiczny Andrzej Wojtowicz AW Clinic

Warsaw, , Poland

Charme Clinique Klinika Stomatologii

Warsaw, , Poland

Hospital Médico Quirúrgico de Conxo

A Coruña, , Spain

Centro Medico Teknon

Barcelona, , Spain

Hospital Universitario Virgen del Rocío

Seville, , Spain

Universidad de Valencia

Valencia, , Spain

Birmingham Community Healthcare NHS Foundation Trust

Birmingham, , United Kingdom

University Hospital of Wales

Cardiff, , United Kingdom

University of Manchester

Manchester, , United Kingdom

University Hospitals of North Midlands NHS Trust

Stoke-on-Trent, , United Kingdom

Countries

Hungary; Italy; Poland; Spain; United Kingdom

References

Gay-Escoda C, Hanna M, Montero A, Dietrich T, Milleri S, Giergiel E, Zoltan TB, Varrassi G. Tramadol/dexketoprofen (TRAM/DKP) compared with tramadol/paracetamol in moderate to severe acute pain: results of a randomised, double-blind, placebo and active-controlled, parallel group trial in the impacted third molar extraction pain model (DAVID study). BMJ Open. 2019 Feb 19;9(2):e023715. doi: 10.1136/bmjopen-2018-023715.

Reference Type: DERIVED

PMID: 30782886 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

DEX-TRA-06

Identifier Type: -

Identifier Source: org_study_id