Etoricoxib Versus Ibuprofen in Third Molar Extraction Pain

March 3, 2009 updated by: Universita di Verona

Evaluation of Analgesic Efficacy of Etoricoxib Compared With Ibuprofen in Third Molar Extraction Pain.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

110

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
analgesic efficacy
Time Frame: 3 days
3 days

Secondary Outcome Measures

Outcome Measure
Time Frame
side effects
Time Frame: 3 days
3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universita di Verona

Investigators

  • Study Director: Roberto Corrocher, MD, Universita di Verona

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Anticipated)

December 1, 2009

Study Completion (Anticipated)

April 1, 2010

Study Registration Dates

First Submitted

March 3, 2009

First Submitted That Met QC Criteria

March 3, 2009

First Posted (Estimate)

March 4, 2009

Study Record Updates

Last Update Posted (Estimate)

March 4, 2009

Last Update Submitted That Met QC Criteria

March 3, 2009

Last Verified

March 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • University of Verona - CE1597

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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