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NCT00006299 · ClinicalTrials.gov registry record · Phase 2
Celebrex for Pain Relief After Oral Surgery
A Phase 2 study of Facial Pain, sponsored by National Institute of Dental and Craniofacial Research (NIDCR).
- Completed
- Registry status
- Phase 2
- Development phase
- 120
- Enrollment target
- 1
- Study location
NCT00006299 is a Phase 2 study of Facial Pain that has completed, run by National Institute of Dental and Craniofacial Research (NIDCR). The registered enrollment target is 120 participants, above the 27-participant average among 3 other Facial Pain trials with a reported enrollment target (344% higher). The trial reports 1 study location across 1 state.
The verdict
NCT00006299, a Phase 2 study of Facial Pain, has completed, sponsored by National Institute of Dental and Craniofacial Research (NIDCR).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 120 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Conditions Studied
Interventions
- DRUG Celebrex
Study Locations (1)
Maryland
- National Institute of Dental And Craniofacial Research (NIDCR) - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 1999-12 |
| Est. Completion | 2004-02 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00006299
The ClinicalTrials.gov registry entry for NCT00006299 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 27-participant average among 3 other Facial Pain trials with a reported enrollment target (344% higher). The listed sponsor is National Institute of Dental and Craniofacial Research (NIDCR), which has 91 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Facial Pain appearing as the primary indexed condition, and to 1 intervention - of which Celebrex is the first listed.
NCT00006299 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT00006299 about?
NCT00006299 is a clinical study titled "Celebrex for Pain Relief After Oral Surgery". 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 al...
What is the current status of trial NCT00006299?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 120 participants. The study started on 1999-12. Estimated completion is 2004-02.
What conditions does trial NCT00006299 study?
This clinical trial studies the following conditions: Facial Pain.
What interventions are being tested in trial NCT00006299?
The interventions under investigation include: Celebrex (DRUG).
Who is sponsoring clinical trial NCT00006299?
This trial is sponsored by National Institute of Dental and Craniofacial Research (NIDCR), which has 91 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00006299 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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