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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02777970
Recruitment Status : Unknown
Verified February 2017 by Menarini Group.
Recruitment status was:  Active, not recruiting
First Posted : May 19, 2016
Last Update Posted : February 10, 2017
Information provided by (Responsible Party):
Menarini Group

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.

Condition or disease Intervention/treatment Phase
Acute Pain Drug: Tramadol Hydrochloride/Dexketoprofen Trometamol Drug: Tramadol Hydrochloride/Paracetamol Drug: Placebo Phase 4

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:

  • Paracetamol/TRAM.HCL
  • Placebo.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 640 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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)
Study Start Date : April 2016
Estimated Primary Completion Date : April 2017
Estimated Study Completion Date : April 2017

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Tramadol/Dexketoprofen

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

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

Drug: Tramadol Hydrochloride/Dexketoprofen Trometamol
Drug: Placebo
Active Comparator: Tramadol/Paracetamol

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

One tablet of Placebo matching Tramadol Hydrochloride/Dexketoprofen Trometamol oral single dose.

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

One tablet of Placebo matching Tramadol Hydrochloride/Dexketoprofen Trometamol 75mg/25mg oral single dose;

Two tablets of Placebo matching Tramadol Hydrochloride/Paracetamol 37.5mg/325mg oral single dose.

Drug: Placebo

Primary Outcome Measures :
  1. TOTPAR6 (Total Pain Relief) [ 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).

Secondary Outcome Measures :
  1. % of patients achieving 50% of max TOTPAR [ Time Frame: 8 hours post-dose ]
    Percentage of patients achieving at least 50% of maximum TOTPAR over 8 hours post-dose.

  2. % of patients achieving 30% of PI (Pain Intensity) reduction over 8 hours post-dose [ Time Frame: 8 hours post-dose ]
    Percentage of patients who achieved at least 30% of PI reduction versus baseline at each pre-specified time point over the 8-hour post-dose period.

  3. 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)

  4. % of patients requiring RM [ Time Frame: 8 hours post-dose ]
    Percentage of patients who required RM within the first over 8 hours post-dose.

  5. 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).

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02777970

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

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Menarini Group Identifier: NCT02777970     History of Changes
Other Study ID Numbers: DEX-TRA-06
First Posted: May 19, 2016    Key Record Dates
Last Update Posted: February 10, 2017
Last Verified: February 2017
Keywords provided by Menarini Group:
Acute pain
Acute moderate to severe pain
Postoperative pain
Dexketoprofen Tramadol
Dexketoprofen trometamol
Tramadol hydrochloride
Multimodal analgesia
Third molar extraction
Fixed drug combination
Additional relevant MeSH terms:
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Acute Pain
Neurologic Manifestations
Signs and Symptoms
Dexketoprofen trometamol
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics, Opioid
Central Nervous System Depressants
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action