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Etoricoxib Versus Ibuprofen in Third Molar Extraction Pain

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2009 by Universita di Verona.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Universita di Verona
ClinicalTrials.gov Identifier:
NCT00855777
First received: March 3, 2009
Last updated: NA
Last verified: March 2009
History: No changes posted

March 3, 2009
March 3, 2009
April 2009
December 2009   (final data collection date for primary outcome measure)
analgesic efficacy [ Time Frame: 3 days ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
side effects [ Time Frame: 3 days ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Etoricoxib Versus Ibuprofen in Third Molar Extraction Pain
Evaluation of Analgesic Efficacy of Etoricoxib Compared With Ibuprofen in Third Molar Extraction Pain.

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Dental Extraction
  • Drug: etoricoxib
    etoricoxib 120 mg/day for 3 days
  • Drug: ibuprofen
    ibuprofen 1,800 mg/day for 3 days
  • Experimental: Etoricoxib
    Etoricoxib 120 mg/day x 3 days
    Intervention: Drug: etoricoxib
  • Active Comparator: Ibuprofen
    Ibuprofen 1800 mg/day x 3 days
    Intervention: Drug: ibuprofen
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
110
April 2010
December 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • subjects with age > 18 years
  • in good health status (assessed in occasion of enrollment visit) without any major systemic illness
  • candidate to third molar extraction and presenting local pain within 2 hours after dental extraction

Exclusion Criteria:

  • patients with any major systemic illness
  • patients with a clinical history of drug abuse
  • patients with hypertension and/or a condition of increased cardiovascular risk
  • pregnant or lactating women
  • patients with a history of hypersensitivity/allergy to analgesic drugs, including classical NSAID or coxibs
  • patients with either high levels of liver enzymes (major of 1.5x the upper limit of reference interval) or of creatinine(major of 1.2x the upper limit of reference interval)
  • patients with either a history of peptic ulcer or of haemorrhagic diathesis
  • patients who can not ensure an adequate compliance for the study
Both
18 Years and older
No
Contact: Roberto Corrocher, MD +39-045-8124401 roberto.corrocher@univr.it
Not Provided
 
NCT00855777
University of Verona - CE1597
No
professor Roberto Corrocher, Department of Clinical and Experimental Medicine - University of Verona
Universita di Verona
Not Provided
Study Director: Roberto Corrocher, MD Universita di Verona
Universita di Verona
March 2009

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