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:
Menarini Group
Collaborator:
PRA International
Information provided by (Responsible Party):
Menarini Group
ClinicalTrials.gov Identifier:
NCT01307020
First received: February 28, 2011
Last updated: November 12, 2012
Last verified: November 2012
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Pain |
Drug: Dexketoprofen Trometamol Drug: Tramadol Hydrochloride Drug: Ibuprofen Drug: Placebo Drug: Dexketoprofen Trometamol + Tramadol Hydrochloride |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | 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 |
Resource links provided by NLM:
Drug Information available for:
Tromethamine
Ibuprofen
Tramadol
Ibuprofen sodium
Tramadol hydrochloride
Ibuprofen lysinate
U.S. FDA Resources
Further study details as provided by Menarini Group:
Primary Outcome Measures:
- 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 %
Secondary Outcome Measures:
- 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.
| Enrollment: | 745 |
| Study Start Date: | February 2011 |
| Study Completion Date: | October 2011 |
| Primary Completion Date: | October 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: Placebo |
Drug: Placebo
Placebo, oral film-coated table, once
|
| Active Comparator: Ibuprofen |
Drug: Ibuprofen
Ibuprofen 400 mg, oral film-coated table, once
|
| Active Comparator: TRAM.HCl high dose |
Drug: Tramadol Hydrochloride
Tramadol Hydrochloride high dose, oral film-coated table, once
|
| Active Comparator: TRAM.HCl low dose |
Drug: Tramadol Hydrochloride
Tramadol Hydrochloride low dose, oral film-coated table, once
|
| Active Comparator: DKP-TRIS high dose |
Drug: Dexketoprofen Trometamol
Dexketoprofen Trometamol high dose, oral film-coated table, once
|
| Active Comparator: DKP-TRIS low dose |
Drug: Dexketoprofen Trometamol
Dexketoprofen Trometamol low dose, oral film-coated table, once
|
| Experimental: DKP-TRIS low dose - TRAM.HCl low dose |
Drug: Dexketoprofen Trometamol + Tramadol Hydrochloride
DKP-TRIS low dose - TRAM.HCl low dose, oral film-coated table, once
|
| Experimental: DKP-TRIS low dose - TRAM.HCl high dose |
Drug: Dexketoprofen Trometamol + Tramadol Hydrochloride
DKP-TRIS low dose - TRAM.HCl high dose, oral film-coated table, once
|
| Experimental: DKP-TRIS high dose - TRAM.HCl low dose |
Drug: Dexketoprofen Trometamol + Tramadol Hydrochloride
DKP-TRIS high dose - TRAM.HCl low dose, oral film-coated tablet, once
|
| Experimental: DKP-TRIS high dose - TRAM.HCl high dose |
Drug: Dexketoprofen Trometamol + Tramadol Hydrochloride
DKP-TRIS high dose - TRAM.HCl high dose, oral film-coated tablet, once
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01307020
Locations
| Germany | |
| Klinik und Polickinik für Mund-Kiefer-Gesichtschirurgie/Plastische Operationen Greifswald | |
| Greifswald, Mecklenburg-Vorpommern, Germany, 17475 | |
| Klinik für Mund-, Kiefer- und Gesichtschirurgie, Universitätsklinikum Schleswig Holstein, Campus Kiel | |
| Kiel, Schleswig-Holstein, Germany, 24105 | |
| Hungary | |
| Dr Tóth Bagi Zoltán Fogászati Rendeloje | |
| Budapest, Hungary, 1052 | |
| Italy | |
| Centro di Farmacologia Clinica per la Sperimentazione dei Farmaci | |
| Pisa, Italy, 56126 | |
| Centro di Ricerche Cliniche di Verona Srl. Policlinico G.B.Rossi | |
| Verona, Italy, 37134 | |
| Poland | |
| Gabinet Stomatologiczny Andrzej Wojtowicz AW Clinic | |
| Warsaw, Mazowieckie, Poland, 00-852 | |
| Dental Service spólka jawna | |
| Warszawa, Mazowieckie, Poland, 02-791 | |
| Spain | |
| Hospital Médico Quirúrgico de Conxo | |
| Santiago de Compostela, A Coruña, Spain, 15706 | |
| Facultad de Odontología. Departamento de Cirugía Bucal y Maxilofacial, University of Barcelona - Bellvitge Institute for Biomedical Research (IDIBELL) | |
| L'Hospitalet de Llobregat, Barcelona, Spain, 08907 | |
| Universidad Complutense de Madrid | |
| Madrid, Spain, 28040 | |
| Departamento de Estomatología, Facultad de Odontología. Universidad de Sevilla | |
| Sevilla, Spain, 41009 | |
| Hospital General Universitario de Valencia | |
| Valencia, Spain, 46014 | |
| Departament d'Estomatologia, Clínica Odontològica, Universidad de Valencia - Fundació Lluís Alcanyís | |
| Valencia, Spain, 046010 | |
| United Kingdom | |
| The School of Dentistry, College of Medical and Dental Sciences, University of Birmingham | |
| Birmingham, England, United Kingdom, B4 6 NN | |
| University Dental School Manchester | |
| Manchester, England, United Kingdom, M15 6FH | |
| University Dental Hospital | |
| Cardiff, Wales, United Kingdom, CF14 4 XY | |
Sponsors and Collaborators
Menarini Group
PRA International
Investigators
| 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) |
More Information
No publications provided
| Responsible Party: | Menarini Group |
| ClinicalTrials.gov Identifier: | NCT01307020 History of Changes |
| Other Study ID Numbers: | DEX-TRA 02, 2010-022798-32 |
| Study First Received: | February 28, 2011 |
| Results First Received: | October 11, 2012 |
| Last Updated: | November 12, 2012 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices Hungary: Research Ethics Medical Committee Italy: Ethics Committee Poland: Ministry of Health Spain: Ministry of Health United Kingdom: Research Ethics Committee |
Keywords provided by Menarini Group:
|
Moderate to severe pain Postoperative pain Analgesics Dexketoprofen Tramadol |
Additional relevant MeSH terms:
|
Analgesics Ibuprofen Tramadol Dexketoprofen trometamol Ketoprofen Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses |
Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Anti-Inflammatory Agents Antirheumatic Agents Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Narcotics Central Nervous System Depressants Analgesics, Opioid |
ClinicalTrials.gov processed this record on May 16, 2013