Etoricoxib Versus Ibuprofen in Third Molar Extraction Pain

NCT ID: NCT00855777

Last Updated: 2009-03-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-04-30
• Study Completion Date: 2010-04-30

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.

Conditions

Dental Extraction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Etoricoxib

Etoricoxib 120 mg/day x 3 days

Group Type: EXPERIMENTAL

etoricoxib

Intervention Type: DRUG

etoricoxib 120 mg/day for 3 days

Ibuprofen

Ibuprofen 1800 mg/day x 3 days

Group Type: ACTIVE_COMPARATOR

ibuprofen

Intervention Type: DRUG

ibuprofen 1,800 mg/day for 3 days

Interventions

etoricoxib

etoricoxib 120 mg/day for 3 days

Intervention Type: DRUG

ibuprofen

ibuprofen 1,800 mg/day for 3 days

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universita di Verona

OTHER

Sponsor Role: lead

Responsible Party

Department of Clinical and Experimental Medicine - University of Verona

Principal Investigators

Roberto Corrocher, MD

Role: STUDY_DIRECTOR

Universita di Verona

Central Contacts

Roberto Corrocher, MD

Role: CONTACT

roberto.corrocher@univr.it

+39-045-8124401

Other Identifiers

University of Verona - CE1597

Identifier Type: -

Identifier Source: org_study_id