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Completed

NCT Number: NCT02777970

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

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.

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Key information

Conditions

Acute Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Dr. Tóth Bagi Zoltán Fogászati Rendeloje, Budapest, Hungary

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tramadol Hydrochloride/Dexketoprofen Trometamol

Drug

Tramadol Hydrochloride/Paracetamol

Drug

Placebo

Drug

Primary outcomes

  1. 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.

Secondary outcomes

  1. % 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."

  2. % 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.

  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)

    FPPAR and MPAR assessed by using stopwatches:

    • 'first perceptible' PAR (FPPAR), i.e, at the moment they first felt any PAR whatsoever;
    • 'meaningful' PAR (MPAR, ie, when the relief from pain became meaningful to them)

  4. % 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.

  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).

Sponsors and collaborators

Lead sponsor

Menarini Group

Industry

Registry information

Official study 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)

Acronym: DAVID

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
May 19, 2016
Registry last updated
Mar 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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