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
  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 4

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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Universita di 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:
Etoricoxib
Ibuprofen
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014