Celebrex for Pain Relief After Oral Surgery

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00006299
First received: September 27, 2000
Last updated: March 3, 2008
Last verified: February 2004
  Purpose

This study will evaluate the effects of the new anti-inflammatory drug, Celebrex, on relieving pain after oral surgery. It is also designed to assess the drug's selective inhibition of a chemical called cyclooxygenase-2 and not its closely related form, cyclooxygenase-1. This selective inhibition allows pain alleviation without the adverse side effects (e.g., bleeding and stomach upset) often associated with anti-inflammatory drugs.

Healthy volunteers who require removal of their third molars are eligible for this study. Participants will have oral surgery for tooth extraction after receiving a local anesthetic (lidocaine) in the mouth and a sedative (midazolam) through an arm vein. On the evening before and 1 hour before surgery, patients will be given a dose of either the standard anti-inflammatory drug ibuprofen (Advil, Nuprin, Motrin), or Celebrex, or a placebo (a pill with no active ingredient). After surgery, a small piece of tubing will be placed in each extraction site and tied to an adjacent tooth to hold it in place. Samples will be collected from the tubing to measure chemicals involved in pain and inflammation. Patients will stay in the clinic for up to 6 hours after surgery while the anesthetic wears off and will complete pain questionnaires. During that time, they may receive acetaminophen plus codeine (Tylenol 3), if needed, for pain. The tubing then will be removed and the patient discharged with standard pain medication.


Condition Intervention Phase
Facial Pain
Drug: Celebrex
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Primary Purpose: Treatment
Official Title: In Vivo Selectivity of Cyclooxygenase Inhibitors in the Oral Surgery Model

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 120
Study Start Date: December 1999
Estimated Study Completion Date: February 2004
Detailed Description:

Prostanoids are mediators that have been implicated in all stages of inflammation. The inhibition of prostanoid synthesis by NSAIDs forms the basis of their therapeutic as well as side effects. NSAIDs directly inhibit cyclooxygenase [COX], which leads to reduction of prostaglandin synthesis and also to gastric erosions, inhibition of platelet aggregation and nephrotoxicity. The identification of the two isoforms of COX lead to the hypothesis that COX-2 is responsible for the production of prostaglandins following tissue injury, while COX-1 is involved in normal homeostasis.

The selective COX-2 inhibitors are believed to be efficacious anti-inflammatory drugs devoid of the side effects associated with the inhibition of COX-1. However, the selectivity of these drugs has only been demonstrated in vitro and ex vivo, which may not be a reliable indicator of the in vivo selectivity. The proposed study aims to evaluate the in vivo selectivity of celecoxib, a drug demonstrated to be a selective inhibitor of COX-2 in vitro in the oral surgery model of acute inflammation.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

INCLUSION CRITERIA:

Healthy volunteers between the ages of 18-65 years.

Patients will be eligible for this study if the two mandibular molars are classified as partial or full bony impactions.

EXCLUSION CRITERIA:

Patients who are allergic to sulfa-drugs.

Patients who have had asthma, hives or an allergic reaction to aspirin, ibuprofen or any similar drugs.

Patients with gastrointestinal ulcers or a history of gastrointestinal bleeding.

Patients who are pregnant or nursing.

Patients of infection or inflammation [pericoronitis] at either extraction site.

Patients with severe kidney disease.

Patients who are taking any of the following drugs: anti-depressants, diuretics, aspirin on a near daily basis, coumadin or other blood thinners.

Patients who are taking drugs known to inhibit P450 2C9 and drugs metabolized by P450 2D6.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00006299

Locations
United States, Maryland
National Institute of Dental And Craniofacial Research (NIDCR)
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00006299     History of Changes
Other Study ID Numbers: 000027, 00-D-0027
Study First Received: September 27, 2000
Last Updated: March 3, 2008
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Celecoxib
Thromboxane B2
Prostaglandin E2
Microdialysis
Ibuprofen

Additional relevant MeSH terms:
Facial Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Cyclooxygenase Inhibitors
Celecoxib
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Therapeutic Uses
Cyclooxygenase 2 Inhibitors
Central Nervous System Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on April 17, 2014