Etoricoxib Versus Ibuprofen in Third Molar Extraction Pain

Sponsor

Universita di Verona (Other)

Overall Status

Unknown status

CT.gov ID

NCT00855777

Collaborator

(none)

110

Enrollment

Arms

Duration (Months)

Study Details

Study Description

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 Design

Study Type:

Interventional

Anticipated 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 :

Apr 1, 2009

Anticipated Primary Completion Date :

Dec 1, 2009

Anticipated Study Completion Date :

Apr 1, 2010

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

analgesic efficacy [3 days]

Secondary Outcome Measures

side effects [3 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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