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NCT00001724 · ClinicalTrials.gov registry record · Phase 2
Local Flurbiprofen to Treat Pain Following Wisdom Tooth Extraction
A Phase 2 study, sponsored by National Institute of Dental and Craniofacial Research (NIDCR).
- Completed
- Registry status
- Phase 2
- Development phase
- 100
- Enrollment target
NCT00001724 is a Phase 2 study that has completed, run by National Institute of Dental and Craniofacial Research (NIDCR). The registered enrollment target is 100 participants.
The verdict
NCT00001724, a Phase 2 study, has completed, sponsored by National Institute of Dental and Craniofacial Research (NIDCR).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 100 participants
- Enrollment target
Study Summary
This study will evaluate the effectiveness of the non-steroidal anti-inflammatory drug flurbiprofen (Ansaid® (Registered Trademark)) in relieving pain following oral surgery. Flurbiprofen is approved by the Food and Drug Administration for treatment of arthritis pain. Patients 16 years of age and older requiring third molar (wisdom tooth) extraction may be eligible for this study. Patients will undergo oral surgery to remove two lower third molar teeth. Before surgery, they will be given a local anesthetic (lidocaine with epinephrine) injected in the mouth and a sedative (Versed) infused through a catheter (thin plastic tube) placed in an arm vein. At the time of surgery, patients will also be given flurbiprofen or a placebo formulation (look-alike substance with no active ingredient) directly into the extraction site and a capsule that also may contain flurbiprofen or placebo. One in seven patients will receive only placebo. All patients will fill out pain questionnaires and stay in the clinic for up to 6 hours for observation of bleeding and medication side effects. Patients who do not have satisfactory pain relief from the test medicine after surgery may request a standard pain reliever. A small blood sample will be collected during surgery and at 15 minutes, one-half hour and 1, 2, 3, 4, 5, 6, 24 and 48 hours after surgery to measure flurbiprofen blood levels. A total of 33 ml (about 2 tablespoons) of blood will be drawn for these tests. Samples collected on the day of surgery will be drawn from the catheter used to administer the sedative; the 24- and 48-hour samples will be taken by needle from an arm or hand vein. Urine samples will also be collected between 4 and 6 hours after surgery and again at 24 and 48 hours after surgery.
Interventions
- DRUG Flurbiprofen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 1997-11 |
| Est. Completion | 2001-11 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00001724
The ClinicalTrials.gov registry entry for NCT00001724 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect. 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 0 conditions, and to 1 intervention - of which Flurbiprofen is the first listed.
NCT00001724 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00001724 about?
NCT00001724 is a clinical study titled "Local Flurbiprofen to Treat Pain Following Wisdom Tooth Extraction". This study will evaluate the effectiveness of the non-steroidal anti-inflammatory drug flurbiprofen (Ansaid® (Registered Trademark)) in relieving pain following oral surgery. Flurbiprofen is approved by the Food and Drug Administration for treatment of arthritis pain. Patients 16 years of age and o...
What is the current status of trial NCT00001724?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 100 participants. The study started on 1997-11. Estimated completion is 2001-11.
What interventions are being tested in trial NCT00001724?
The interventions under investigation include: Flurbiprofen (DRUG).
Who is sponsoring clinical trial NCT00001724?
This trial is sponsored by National Institute of Dental and Craniofacial Research (NIDCR), which has 91 total clinical trials registered on ClinicalTrials.gov.
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