Etoricoxib Versus Ibuprofen in Third Molar Extraction Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by:
Universita di Verona

Brief Summary:

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Etoricoxib
Etoricoxib 120 mg/day x 3 days
Drug: etoricoxib
etoricoxib 120 mg/day for 3 days
Active Comparator: Ibuprofen
Ibuprofen 1800 mg/day x 3 days
Drug: ibuprofen
ibuprofen 1,800 mg/day for 3 days

Primary Outcome Measures :
  1. analgesic efficacy [ Time Frame: 3 days ]

Secondary Outcome Measures :
  1. side effects [ Time Frame: 3 days ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00855777

Contact: Roberto Corrocher, MD +39-045-8124401

Sponsors and Collaborators
Universita di Verona
Study Director: Roberto Corrocher, MD Universita di Verona

Responsible Party: professor Roberto Corrocher, Department of Clinical and Experimental Medicine - University of Verona Identifier: NCT00855777     History of Changes
Other Study ID Numbers: University of Verona - CE1597
First Posted: March 4, 2009    Key Record Dates
Last Update Posted: March 4, 2009
Last Verified: March 2009

Keywords provided by Universita di Verona:
third molar extraction
analgesic efficacy

Additional relevant MeSH terms:
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cyclooxygenase 2 Inhibitors