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

March 1, 2021 updated by: Menarini Group

Analgesic Efficacy of Oral Dexketoprofen Trometamol/Tramadol Hydrochloride Versus Tramadol Hydrochloride/Paracetamol: a Randomised, Double-blind, Placebo and Active-controlled, Parallel Group Study in Moderate to Severe Acute Pain After Removal of Impacted Lower Third Molar (Dexketoprofen Analgesic eVolution wIth tramaDol- DAVID Study)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

654

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hungary
      • Budapest, Hungary, 1052
        • Dr. Tóth Bagi Zoltán Fogászati Rendeloje
      • Budapest, Hungary, 1126
        • OralMed Studio Fogászati és Szájsebészeti Kft.
      • Szeged, Hungary, 6725
        • Szegedi Tudomanyegyetem
  • Italy
      • L'Aquila, Italy, 67100
        • Ospedale Civile San Salvatore di L'Aquila
      • Milan, Italy, 20122
        • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
      • Pisa, Italy, 56126
        • Azienda Ospedaliero-Universitaria Pisana
      • Verona, Italy, 37134
        • Azienda Ospedaliera Universitaria Integrata
  • Poland
      • Bialystok, Poland, 15-078
        • Ars-Dent
      • Warszawa, Poland, 00-852
        • Gabinet Stomatologiczny Andrzej Wojtowicz AW Clinic
      • Warszawa, Poland, 02-670
        • Charme Clinique Klinika Stomatologii
  • Spain
      • Barcelona, Spain, 08022
        • Centro Médico Teknon
      • La Coruna, Spain, 15702
        • Hospital Médico Quirúrgico de Conxo
      • Sevilla, Spain, 41009
        • Hospital Universitario Virgen del Rocio
      • Valencia, Spain, 46010
        • Universidad de Valencia
  • United Kingdom
      • Birmingham, United Kingdom, B4 6NN
        • Birmingham Community Healthcare NHS Foundation Trust
      • Cardiff, United Kingdom, CF14 4XT
        • University Hospital of wales
      • Manchester, United Kingdom, M15 6FH
        • University of Manchester
      • Stoke on Trent, United Kingdom, ST4 6QG
        • University Hospitals of North Midlands NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: Placebo
Drug: Tramadol Hydrochloride/Dexketoprofen Trometamol
Active Comparator: 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.

.
Drug: Placebo
Drug: Tramadol Hydrochloride/Paracetamol
Placebo Comparator: 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.
Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
TOTPAR6 (Total Pain Relief Over 6 Hours Post-dose)
Time Frame: 6 hours post-dose

TOTPAR calculated as the weighted sum of the PAR scores, measured according to a 5-point VRS (Verbal Rating Scale) from 0=no relief to 4=complete relief, over 6 hours post-dose (TOTPAR6).

The TOTPAR6 ranges from a minimum of 0 to a maximum of 24.
6 hours post-dose

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
% of Patients Achieving 50% of Max TOTPAR
Time Frame: 8 hours post-dose
Percentage of patients who achieved at least 50% of the maximum TOTPAR at 8 hours. In the present trial the achievable TOTPAR over 8 hours ranges between 0 and 32."
8 hours post-dose
% of Patients Achieving at Least 30% of PI (Pain Intensity) Reduction Over 8 Hours Post-dose
Time Frame: 8 hours post-dose
Percentage of patients who achieve at least 30% of PI Reduction versus baseline Over 8 Hours Post-dose. Percentage change of PI is calculated using the baseline value minus the PI assessed at 8 hours post-dose divided for the baseline value, then multiplied for 100.
8 hours post-dose
Time to Confirmed FPPAR (First Perceptible Pain Relief)
Time Frame: 2 hours post-dose

Time to confirmed FPPAR (time to onset of analgesia) - i.e. time to FPPAR if confirmed by experiencing Meaningful Pain Relief (MPAR)

FPPAR and MPAR assessed by using stopwatches:

  1. 'first perceptible' PAR (FPPAR), i.e, at the moment they first felt any PAR whatsoever;
  2. 'meaningful' PAR (MPAR, ie, when the relief from pain became meaningful to them)
2 hours post-dose
% of Patients Requiring RM (Rescue Medication)
Time Frame: 8 hours post-dose
Percentage of patients who required RM within the first over 8 hours post-dose.
8 hours post-dose
PGE (Patient Global Evaluation)
Time Frame: 8 hours postdose
PGE of the study medication (measured according to a five-point VRS from 1 = poor to 5 = excellent) at 8 hours post-dose or whenever the patient uses Rescue Medication (RM).
8 hours postdose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Menarini Group

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2016

Primary Completion (Actual)

February 14, 2017

Study Completion (Actual)

February 14, 2017

Study Registration Dates

First Submitted

May 13, 2016

First Submitted That Met QC Criteria

May 17, 2016

First Posted (Estimate)

May 19, 2016

Study Record Updates

Last Update Posted (Actual)

March 24, 2021

Last Update Submitted That Met QC Criteria

March 1, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DEX-TRA-06

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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