Analgesic Effect of Different Combinations of Dexketoprofen Trometamol With Tramadol Hydrochloride in a Model of Moderate to Severe Pain (DEX-TRA 02)

This study has been completed.
Sponsor:
Collaborator:
PRA International
Information provided by (Responsible Party):
Menarini Group
ClinicalTrials.gov Identifier:
NCT01307020
First received: February 28, 2011
Last updated: July 31, 2013
Last verified: July 2013

February 28, 2011
July 31, 2013
February 2011
October 2011   (final data collection date for primary outcome measure)
Percentage of Patients Achieving at Least 50 % of the Theoretical Maximum Total Pain Relief Score at 6 Hours Post-dosing. [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
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 %
Same as current
Complete list of historical versions of study NCT01307020 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
    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 4, 8 and 12 hours(maxTOTPAR4h= 16, maxTOTPAR8h= 32 and maxTOTPAR12h= 48, respectively) Unit of measure is %
  • Percentage of Patients Using Rescue Medication at 6 Hours [ Time Frame: Baseline to 6 hours ] [ Designated as safety issue: No ]
    Percentage of patients using rescue medication at 6 hours post-dosing.
  • 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 ] [ Designated as safety issue: No ]
    (maxTOTPAR4h= 16, maxTOTPAR8h= 24 and maxTOTPAR12h= 48, respectively) Unit of measure is %
  • TOTPAR: Total pain relief calculated as the weighted sum of the pain relief scores at 4h, 6h, 8h and 12h post-dosing. [ Time Frame: 4, 6, 8 and 12 hours ] [ Designated as safety issue: No ]
  • Percentage of the theoretical maximum total pain relief (% maxTOTPAR) score at 4, 6, 8 and 12 hours post-dosing. [ Time Frame: 4, 6, 8 and 12 hours ] [ Designated as safety issue: No ]
    [% maxTOTPAR = TOTPAR/maxTOTPAR * 100]
  • Safety and tolerability will be assessed in terms of frequency and severity of AEs as well as frequency of clinically significant changes in physical examination, ECG and lab test. [ Time Frame: 10 ± 3 days ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Analgesic Effect of Different Combinations of Dexketoprofen Trometamol With Tramadol Hydrochloride in a Model of Moderate to Severe Pain
Double-blind, Randomised, Placebo and Active Controlled, Parallel Group Study to Evaluate the Analgesic Effect of a Single Oral Administration of Four Different Combination Doses of DKP.TRIS With TRAM.HCL in Comparison With the Single Agents, on Moderate to Severe Pain Following Impacted Third Mandibular Molar Tooth Extraction

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Pain
  • Drug: Dexketoprofen Trometamol
    Dexketoprofen Trometamol low dose, oral film-coated table, once
  • Drug: Dexketoprofen Trometamol
    Dexketoprofen Trometamol high dose, oral film-coated table, once
  • Drug: Tramadol Hydrochloride
    Tramadol Hydrochloride low dose, oral film-coated table, once
  • Drug: Tramadol Hydrochloride
    Tramadol Hydrochloride high dose, oral film-coated table, once
  • Drug: Ibuprofen
    Ibuprofen 400 mg, oral film-coated table, once
  • Drug: Placebo
    Placebo, oral film-coated table, once
  • Drug: Dexketoprofen Trometamol + Tramadol Hydrochloride
    DKP-TRIS low dose - TRAM.HCl low dose, oral film-coated table, once
  • Drug: Dexketoprofen Trometamol + Tramadol Hydrochloride
    DKP-TRIS low dose - TRAM.HCl high dose, oral film-coated table, once
  • Drug: Dexketoprofen Trometamol + Tramadol Hydrochloride
    DKP-TRIS high dose - TRAM.HCl low dose, oral film-coated tablet, once
  • Drug: Dexketoprofen Trometamol + Tramadol Hydrochloride
    DKP-TRIS high dose - TRAM.HCl high dose, oral film-coated tablet, once
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Active Comparator: Ibuprofen
    Intervention: Drug: Ibuprofen
  • Active Comparator: TRAM.HCl high dose
    Intervention: Drug: Tramadol Hydrochloride
  • Active Comparator: TRAM.HCl low dose
    Intervention: Drug: Tramadol Hydrochloride
  • Active Comparator: DKP-TRIS high dose
    Intervention: Drug: Dexketoprofen Trometamol
  • Active Comparator: DKP-TRIS low dose
    Intervention: Drug: Dexketoprofen Trometamol
  • Experimental: DKP-TRIS low dose - TRAM.HCl low dose
    Intervention: Drug: Dexketoprofen Trometamol + Tramadol Hydrochloride
  • Experimental: DKP-TRIS low dose - TRAM.HCl high dose
    Intervention: Drug: Dexketoprofen Trometamol + Tramadol Hydrochloride
  • Experimental: DKP-TRIS high dose - TRAM.HCl low dose
    Intervention: Drug: Dexketoprofen Trometamol + Tramadol Hydrochloride
  • Experimental: DKP-TRIS high dose - TRAM.HCl high dose
    Intervention: Drug: Dexketoprofen Trometamol + Tramadol Hydrochloride
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
745
October 2011
October 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany,   Hungary,   Italy,   Poland,   Spain,   United Kingdom
 
NCT01307020
DEX-TRA 02, 2010-022798-32
No
Menarini Group
Menarini Group
PRA International
Study Chair: Cosme Gay-Escoda, Professor Department of Oral and Maxillofacial Surgery, School of Dentistry, University of Barcelona - Bellvitge Institute for Biomedical Research (IDIBELL) 08907 Hospitalet de Llobregat, Barcelona (Spain)
Study Chair: R Andrew Moore, Professor Pain Research & Nuffield Division of Anaesthesics, Department of Clinical Neurosciences, University of Oxford. The Churchill, Oxford OX3 7LJ (United Kingdom)
Menarini Group
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP