Etoricoxib Versus Ibuprofen in Third Molar Extraction Pain

Dental Extraction Clinical Trial

Official title:

Evaluation of Analgesic Efficacy of Etoricoxib Compared With Ibuprofen in Third Molar Extraction Pain.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00855777
• Other study ID #: University of Verona - CE1597
• Status: Not yet recruiting
• Phase: Phase 4
• First received: March 3, 2009
• Last updated: March 3, 2009
• Start date: April 2009
• Est. completion date: April 2010

Study information

• Verified date: March 2009
• Source: Universita di Verona
• Contact: Roberto Corrocher, MD
• Phone: +39-045-8124401
• Email: roberto.corrocher[@]univr.it
• Is FDA regulated: No
• Health authority: Italy: The Italian Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 110
• Est. completion date: April 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dental Extraction

Intervention

Drug:
• etoricoxib
etoricoxib 120 mg/day for 3 days
• ibuprofen
ibuprofen 1,800 mg/day for 3 days

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universita di Verona

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	analgesic efficacy		3 days	No
Secondary	side effects		3 days	Yes