Analgesic Effect of Different Combinations of Dexketoprofen Trometamol With Tramadol Hydrochloride in a Model of Moderate to Severe Pain

Menarini Group745 enrolled

Overview

The purpose of this study is to evaluate the analgesic efficacy of Dexketoprofen Trometamol and Tramadol Hydrochloride given in combinations and the analgesic efficacy of each single component in comparison to placebo on moderate to severe pain following impacted third mandibular molar tooth extraction. Ibuprofen will be used as an active control to validate the pain model.

The aim of this study is to develop a combination of Dexketoprofen Trometamol (DKP.TRIS) and Tramadol Hydrochloride (TRAM.HCl) for the treatment of acute moderate to severe pain, based on the rationale that more than one drug is necessary in most patients suffering of acute and chronic pain, particularly of moderate to severe intensity. DKP.TRIS and TRAM.HCl have different mechanisms of action, therefore their combination is expect to result in an additive or synergistic analgesia, thus allowing a decrease in the required doses of the individual agents, and consequently a reduced risk of adverse events In this study, patients who present moderate to severe pain after impacted third mandibular molar tooth extraction will be randomised to a total of 10 treatment arms including 4 combinations of DKP.TRIS + TRAM.HCl, the four corresponding single treatments, placebo and ibuprofen. Treatment administration will be followed by a 24-hour pain and analgesic effect assessment.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

745

Conditions

Pain

Interventions

Dexketoprofen TrometamolDRUG

Dexketoprofen Trometamol low dose, oral film-coated table, once

Dexketoprofen TrometamolDRUG

Dexketoprofen Trometamol high dose, oral film-coated table, once

Tramadol HydrochlorideDRUG

Tramadol Hydrochloride low dose, oral film-coated table, once

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: Patients meeting ALL the following criteria will be eligible for entry into the study: * Male or female patients aged 18 to 70 years old. Females participating in the study must be either: of non-childbearing potential, or willing to use a highly effective contraceptive method. * Scheduled for outpatient surgical extraction -under local anaesthesia- of third mandibular molar teeth, with at least one of which is fully or partially impacted in the mandible requiring bone manipulation. * Normal physical examination or without clinically relevant abnormalities. At randomisation (after surgery): No intake of analgesics (including prescription and over the counter drugs) within 24h prior to the surgery. * No complication during the surgery, duration of surgery \< 1 hour and not requiring re-anaesthesia. * Patients experiencing pain of moderate or higher intensity in the first four hours after the end of surgery. Exclusion Criteria: * History of allergy or hypersensitivity to NSAIDs, opioids or acetyl salicylic acid. * History of asthma, bronchospasm, acute rhinitis, nasal polyps, urticaria or angioneurotic oedema. * History of peptic ulcer, gastrointestinal disorders by NSAIDs, gastrointestinal bleeding or other active bleedings.

Locations (16)

Klinik und Polickinik für Mund-Kiefer-Gesichtschirurgie/Plastische Operationen Greifswald

Greifswald, Mecklenburg-Vorpommern, Germany

Outcomes

Primary Outcomes

Percentage of Patients Achieving at Least 50 % of the Theoretical Maximum Total Pain Relief Score at 6 Hours Post-dosing.

Pain relief is measured by a verbal rating scale (ranging from 0=none to 4=complete). Theoretical maximum TOTPAR at 6 hours is calculated by summing up the maximum score of analgesia which the patient can attribute at defined time points along 6 hour (maxTOTPAR6h= 24). Unit of measure is %

Time frame: 6 hours

Secondary Outcomes

Percentage of Patients Achieving at Least 50 % of the Theoretical Maximum Total Pain Relief Score at 4, 8 and 12 Hours Post-dosing.

Time frame: 4, 8 and 12 hours

Percentage of Patients Using Rescue Medication at 6 Hours

Percentage of patients using rescue medication at 6 hours post-dosing.

Time frame: Baseline to 6 hours

Data from ClinicalTrials.gov

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