Etoricoxib Versus Ibuprofen in Third Molar Extraction Pain
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|ClinicalTrials.gov Identifier: NCT00855777|
Recruitment Status : Unknown
Verified March 2009 by Universita di Verona.
Recruitment status was: Not yet recruiting
First Posted : March 4, 2009
Last Update Posted : March 4, 2009
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 or disease||Intervention/treatment||Phase|
|Dental Extraction||Drug: etoricoxib Drug: ibuprofen||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||110 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Evaluation of Analgesic Efficacy of Etoricoxib Compared With Ibuprofen in Third Molar Extraction Pain.|
|Study Start Date :||April 2009|
|Estimated Primary Completion Date :||December 2009|
|Estimated Study Completion Date :||April 2010|
Etoricoxib 120 mg/day x 3 days
etoricoxib 120 mg/day for 3 days
Active Comparator: Ibuprofen
Ibuprofen 1800 mg/day x 3 days
ibuprofen 1,800 mg/day for 3 days
- analgesic efficacy [ Time Frame: 3 days ]
- side effects [ Time Frame: 3 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00855777
|Contact: Roberto Corrocher, MDfirstname.lastname@example.org|
|Study Director:||Roberto Corrocher, MD||Universita di Verona|