Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006299
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2000-09-27
Brief Title:
Celebrex for Pain Relief After Oral Surgery
Sponsor:
National Institute of Dental and Craniofacial Research NIDCR
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
In Vivo Selectivity of Cyclooxygenase Inhibitors in the Oral Surgery Model
Status:
COMPLETED
Status Verified Date:
2004-02
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 new anti-inflammatory drug Celebrex on relieving pain after oral surgery It is also designed to assess the drugs 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 eg 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
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
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
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
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-0027 | None | None | None |