Etoricoxib Versus Ibuprofen in Third Molar Extraction Pain - Full Text View

Sponsor:	Universita di Verona
Information provided by:	Universita di Verona
ClinicalTrials.gov Identifier:	NCT00855777

Purpose

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	Intervention	Phase
Dental Extraction	Drug: etoricoxib Drug: ibuprofen	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Evaluation of Analgesic Efficacy of Etoricoxib Compared With Ibuprofen in Third Molar Extraction Pain.

Resource links provided by NLM:

Drug Information available for: Ibuprofen Etoricoxib

U.S. FDA Resources

Further study details as provided by Universita di Verona:

Primary Outcome Measures:

analgesic efficacy [ Time Frame: 3 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

side effects [ Time Frame: 3 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	110
Study Start Date:	April 2009
Estimated Study Completion Date:	April 2010
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00855777

Contacts

Contact: Roberto Corrocher, MD

+39-045-8124401

roberto.corrocher@univr.it

Sponsors and Collaborators

Universita di Verona

Investigators

Study Director:

Roberto Corrocher, MD

University of Verona

More Information

No publications provided

Responsible Party:	professor Roberto Corrocher, Department of Clinical and Experimental Medicine - University of Verona
ClinicalTrials.gov Identifier:	NCT00855777 History of Changes
Other Study ID Numbers:	University of Verona - CE1597
Study First Received:	March 3, 2009
Last Updated:	March 3, 2009
Health Authority:	Italy: The Italian Medicines Agency

Keywords provided by Universita di Verona:

third molar extraction
etoricoxib
ibuprofen
analgesic efficacy
pain

Additional relevant MeSH terms:

Analgesics
Ibuprofen
Etoricoxib
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cyclooxygenase 2 Inhibitors

ClinicalTrials.gov processed this record on February 09, 2012