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Sponsored by: |
Universita di Verona |
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Information provided by: | Universita di Verona |
ClinicalTrials.gov Identifier: | NCT00855777 |
The aim of this study is to evaluate the analgesic efficacy of etoricoxib compared with a well known and widely used non-steroid antinflammatory drug, ibuprofen, in third molar extraction pain. At this time, there are no data about the efficacy of etoricoxib for reducing pain following dental extraction. This will be a single center, randomized, double-blind study, in which patients with moderate to severe pain following third molar extraction will be randomized to receive etoricoxib (120 mg in a single dose + 2 dose of placebo pro day for 3 days) or ibuprofen (1800 mg in 3 doses pro day for 3 days). Paracetamol plus codeine will be used as rescue medication. Pain assessment will be performed using a 11-point pain intensity scale (0 = no pain and 10 = worster pain) during the first 3 days after dental extraction. Patients will be enrolled 15 days before the dental extraction. During enrollment visit a complete clinical evaluation with particular attention for potential exclusion criteria (e.g. hypertension and cardiovascular risk factors) as well as blood analyses will be performed. A follow-up visit will be performed 15 days after the dental extraction. Tolerability will be assessed through recording of adverse events.
Condition | Intervention | Phase |
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Dental Extraction |
Drug: etoricoxib Drug: ibuprofen |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Evaluation of Analgesic Efficacy of Etoricoxib Compared With Ibuprofen in Third Molar Extraction Pain. |
Estimated Enrollment: | 110 |
Study Start Date: | April 2009 |
Estimated Study Completion Date: | April 2010 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Etoricoxib: Experimental
Etoricoxib 120 mg/day x 3 days
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Drug: etoricoxib
etoricoxib 120 mg/day for 3 days
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Ibuprofen: Active Comparator
Ibuprofen 1800 mg/day x 3 days
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Drug: ibuprofen
ibuprofen 1,800 mg/day for 3 days
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Roberto Corrocher, MD | +39-045-8124401 | roberto.corrocher@univr.it |
Study Director: | Roberto Corrocher, MD | University of Verona |
Responsible Party: | Department of Clinical and Experimental Medicine - University of Verona ( professor Roberto Corrocher ) |
Study ID Numbers: | University of Verona - CE1597 |
Study First Received: | March 3, 2009 |
Last Updated: | March 3, 2009 |
ClinicalTrials.gov Identifier: | NCT00855777 History of Changes |
Health Authority: | Italy: The Italian Medicines Agency |
third molar extraction etoricoxib ibuprofen analgesic efficacy pain |
Anti-Inflammatory Agents Ibuprofen Analgesics, Non-Narcotic Cyclooxygenase Inhibitors Etoricoxib |
Anti-Inflammatory Agents, Non-Steroidal Pain Peripheral Nervous System Agents Analgesics Antirheumatic Agents |
Anti-Inflammatory Agents Ibuprofen Molecular Mechanisms of Pharmacological Action Etoricoxib Physiological Effects of Drugs Cyclooxygenase Inhibitors Enzyme Inhibitors Pharmacologic Actions |
Analgesics, Non-Narcotic Sensory System Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents |