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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

Page last updated: August 23, 2015

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