Etoricoxib Versus Ibuprofen in Third Molar Extraction Pain
Information source: Universita di Verona
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Dental Extraction
Intervention: etoricoxib (Drug); ibuprofen (Drug)
Phase: Phase 4
Status: Not yet recruiting
Sponsored by: Universita di Verona Official(s) and/or principal investigator(s): Roberto Corrocher, MD, Study Director, Affiliation: Universita di Verona
Overall contact: Roberto Corrocher, MD, Phone: +39-045-8124401, Email: roberto.corrocher@univr.it
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.
Clinical Details
Official title: Evaluation of Analgesic Efficacy of Etoricoxib Compared With Ibuprofen in Third Molar Extraction Pain.
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: analgesic efficacy
Secondary outcome: side effects
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Roberto Corrocher, MD, Phone: +39-045-8124401, Email: roberto.corrocher@univr.it Additional Information
Starting date: April 2009
Last updated: March 3, 2009
|