Etoricoxib Versus Ibuprofen in Third Molar Extraction Pain

NCT00855777 | Unknown Phase 4

• 1 other identifier: University of Verona - CE1597
• Study Type: interventional
• Target: 110
• Locations: 0 countries
• Sites: N/A

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

Keywords

third molar extraction; etoricoxib; ibuprofen; analgesic efficacy; pain

Outcome Measures

Primary Outcomes (1)

• analgesic efficacy

  3 days

Secondary Outcomes (1)

• side effects

  3 days

Study Arms (2)

Etoricoxib

EXPERIMENTAL

Etoricoxib 120 mg/day x 3 days

Drug: etoricoxib

Ibuprofen

ACTIVE COMPARATOR

Ibuprofen 1800 mg/day x 3 days

Drug: ibuprofen

Interventions

etoricoxib DRUG

etoricoxib 120 mg/day for 3 days

Etoricoxib

ibuprofen DRUG

ibuprofen 1,800 mg/day for 3 days

Ibuprofen

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universita di Verona: lead

MeSH Terms

Conditions

Pain

Interventions

Etoricoxib; Ibuprofen

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sulfones; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids

Study Officials

• Roberto Corrocher, MD

  Universita di Verona

  STUDY DIRECTOR

Central Study Contacts

Roberto Corrocher, MD

CONTACT

+39-045-8124401; roberto.corrocher@univr.it

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 3, 2009
• First Posted: March 4, 2009
• Study Start: April 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: April 1, 2010
• Last Updated: March 4, 2009

Record last verified: 2009-03