Etoricoxib Versus Ibuprofen in Third Molar Extraction Pain

The recruitment status of this study is unknown because the information has not been verified recently.

Verified March 2009 by Universita di Verona.
Recruitment status was Not yet recruiting

Sponsor:

Information provided by:

Universita di Verona

ClinicalTrials.gov Identifier:

NCT00855777

First received: March 3, 2009

Last updated: NA

Last verified: March 2009

History: No changes posted

Tracking Information

First Received Date ^ICMJE

March 3, 2009

Last Updated Date

March 3, 2009

Start Date ^ICMJE

April 2009

Estimated Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Etoricoxib Versus Ibuprofen in Third Molar Extraction Pain

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Dental Extraction

Intervention ^ICMJE

Drug: etoricoxib
etoricoxib 120 mg/day for 3 days
Drug: ibuprofen
ibuprofen 1,800 mg/day for 3 days

Study Arm (s)

Experimental: Etoricoxib
Etoricoxib 120 mg/day x 3 days

Intervention: Drug: etoricoxib
Active Comparator: Ibuprofen
Ibuprofen 1800 mg/day x 3 days

Intervention: Drug: ibuprofen

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

110

Estimated Completion Date

April 2010

Estimated Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Roberto Corrocher, MD

+39-045-8124401

roberto.corrocher@univr.it

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT00855777

Other Study ID Numbers ^ICMJE

University of Verona - CE1597

Has Data Monitoring Committee

Responsible Party

professor Roberto Corrocher, Department of Clinical and Experimental Medicine - University of Verona

Study Sponsor ^ICMJE

Universita di Verona

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Roberto Corrocher, MD

University of Verona

Information Provided By

Universita di Verona

Verification Date

March 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top