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

Menarini Group654 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

654

Conditions

Acute Pain

Interventions

Tramadol Hydrochloride/Dexketoprofen TrometamolDRUG

Tramadol Hydrochloride/ParacetamolDRUG

PlaceboDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (18)

Dr. Tóth Bagi Zoltán Fogászati Rendeloje

Budapest, Hungary

OralMed Studio Fogászati és Szájsebészeti Kft.

Budapest, Hungary

Outcomes

Primary Outcomes

TOTPAR6 (Total Pain Relief Over 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.

Time frame: 6 hours post-dose

Secondary Outcomes

% of Patients Achieving 50% of Max TOTPAR

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."

Time frame: 8 hours post-dose

% of Patients Achieving at Least 30% of PI (Pain Intensity) Reduction Over 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.

Time frame: 8 hours post-dose

Time to Confirmed FPPAR (First Perceptible Pain Relief)

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)

Time frame: 2 hours post-dose

% of Patients Requiring RM (Rescue Medication)

Percentage of patients who required RM within the first over 8 hours post-dose.

Time frame: 8 hours post-dose

PGE (Patient Global Evaluation)

Data from ClinicalTrials.gov

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