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NCT00006070 · ClinicalTrials.gov registry record · Phase 2
Etanercept (Enbrel) to Treat Pain and Swelling After Third Molar Extraction
A Phase 2 study, sponsored by National Institute of Dental and Craniofacial Research (NIDCR).
- Completed
- Registry status
- Phase 2
- Development phase
- 86
- Enrollment target
NCT00006070 is a Phase 2 study that has completed, run by National Institute of Dental and Craniofacial Research (NIDCR). The registered enrollment target is 86 participants.
The verdict
NCT00006070, a Phase 2 study, has completed, sponsored by National Institute of Dental and Craniofacial Research (NIDCR).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 86 participants
- Enrollment target
Study Summary
This study will evaluate the effects of the anti-inflammatory drug etanercept (Enbrel) on relieving pain and swelling after oral surgery. The Food and Drug Administration has approved Enbrel for treating symptoms of rheumatoid arthritis, including pain. Healthy volunteers 16 to 35 years of age who require third molar (wisdom teeth) extractions may be eligible for this study. Participants must not be allergic to aspirin or to non-steroidal anti-inflammatory drugs (NSAIDs). Candidates will be screened for eligibility with a medical history and oral examination, including X-rays if needed. Participation in the study requires four clinic visits: two for surgery and two for follow-up: Visit 1: Patients will have ultrasound pictures taken to measure cheek size. One hour before surgery, they will receive a dose of either 25 milligrams (mg) of Enbrel; 15 mg of the standard pain medicine Toradol; or a placebo (salt-water) through an arm vein. A local injection of an anesthetic (lidocaine) will be given before surgery to numb the mouth, and a sedative (Versed) will be infused through a vein to induce sleepiness. When the anesthetic takes effect, a small piece of tissue will be removed from the inside of the cheek, and then the upper and lower molars on one side of the mouth will be extracted. After surgery, a small piece of tubing will be placed in the lower extraction site, from which samples will be collected to measure chemicals involved in pain and inflammation. Patients will stay in the clinic for 4 hours after surgery while the anesthetic wears off and will complete pain questionnaires during that time. If, an hour after surgery, patients have pain that is not relieved by the treatment given before surgery, they may receive acetaminophen (Tylenol) and codeine for pain. Another biopsy will be taken (under local anesthetic) from the inside of the cheek when pain occurs or at the end of the 4-hour observation period. The tubing then will be removed and the patient disc
Interventions
- DRUG etanercept (Enbrel)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 86 participants |
| Start Date | 2000-07 |
| Est. Completion | 2004-05 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00006070
The ClinicalTrials.gov registry entry for NCT00006070 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 86 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 etanercept (Enbrel) is the first listed.
NCT00006070 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00006070 about?
NCT00006070 is a clinical study titled "Etanercept (Enbrel) to Treat Pain and Swelling After Third Molar Extraction". This study will evaluate the effects of the anti-inflammatory drug etanercept (Enbrel) on relieving pain and swelling after oral surgery. The Food and Drug Administration has approved Enbrel for treating symptoms of rheumatoid arthritis, including pain. Healthy volunteers 16 to 35 years of age who ...
What is the current status of trial NCT00006070?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 86 participants. The study started on 2000-07. Estimated completion is 2004-05.
What interventions are being tested in trial NCT00006070?
The interventions under investigation include: etanercept (Enbrel) (DRUG).
Who is sponsoring clinical trial NCT00006070?
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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