Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006070
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2000-07-18
Brief Title:
Etanercept Enbrel to Treat Pain and Swelling After Third Molar Extraction
Sponsor:
National Institute of Dental and Craniofacial Research NIDCR
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Safety and Efficacy of a TNF Receptor Fusion Protein for Injury-Induced Inflammation and Sequelae
Status:
COMPLETED
Status Verified Date:
2004-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 discharged with Tylenol and codeine for pain
Visit 2
Patients will return to the clinic in the morning 48 hours after the oral surgery for a 1- to 2-hour visit They will fill out questionnaires undergo ultrasound imaging of both cheeks and have another biopsy taken from the inside of the cheek on the operated side
Visits 3 and 4
Three weeks after the first surgery patients will schedule extraction of the two wisdom teeth on the other side of the mouth and the procedures for visits 1 and 2 will be repeated
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 discharged with Tylenol and codeine for pain
Visit 2
Patients will return to the clinic in the morning 48 hours after the oral surgery for a 1- to 2-hour visit They will fill out questionnaires undergo ultrasound imaging of both cheeks and have another biopsy taken from the inside of the cheek on the operated side
Visits 3 and 4
Three weeks after the first surgery patients will schedule extraction of the two wisdom teeth on the other side of the mouth and the procedures for visits 1 and 2 will be repeated
Detailed Description:
The proposed investigation is a randomized double-blind placebo and positive-controlled within-subjects design clinical study to evaluate the role of the cytokine tumor necrosis factor TNF in acute inflammation using a specific TNF receptor antagonist etanercept Enbrel Immunex Corporation Seattle WA The goal of this study is to determine whether inhibition of TNF bioactivity can attenuate acute inflammation The anti-inflammatory and adverse effects of etanercept a recombinant TNF receptor fusion protein will be evaluated using a model of tissue injury the oral surgery model Briefly healthy volunteers referred for third molar extraction will undergo the surgical extraction of third molars with local anesthesia and conscious sedation At the completion of the surgical procedure a microdialysis probe will be placed under the mucogingival flap previously elevated for the surgical procedure and subjects will be observed for pain and swelling over the course of four hours following surgery Tissue biopsies prior to and following surgery will be obtained from the buccal mucosa Etanercept or control will be administered parenterally one hour prior to surgery Tissue levels of pro-inflammatory cytokines growth factors and inflammatory mediators will be measured at time intervals postoperatively Pain and swelling will be assessed postoperatively over the course of four hours and at 48 hours Demonstration of amelioration of pain swelling andor changes in levels of tissue mediators will be taken as evidence of an acute anti-inflammatory effect of etanercept Since the fusion protein hereafter TNFRfc specifically binds TNF-alpha and prevents its interaction with cellular receptors changes in the inflammatory cascade and clinical endpoints of inflammation may provide insight into role of TNF-alpha in the pathophysiology of acute inflammation and its clinical sequela
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 00-D-0168 | None | None | None |