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ABOUT THIS STUDY
Surgery initiates a complex cascade of events involving the release of chemical compounds
from nerve endings and damaged tissue which leads to an inflammatory and pain response. The
purpose of this investigation is to measure various chemical mediators in the blood and
cerebrospinal fluid, and to test the hypothesis that they will be decreased in patients
treated with a COX-2 inhibitor.
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
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Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Neurosurgery, Pain
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
Adult Trials: 18+ Years
18-80 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details
- Patients undergoing surgery requiring lumbar drain placement
Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
- Contraindication to COX-2 inhibitor (renal or hepatic insufficiency)
- Known adverse reaction to nonsteroidal anti-inflammatory drugs (NSAIDs)
- Use of NSAID or COX-2 within 7 days prior to surgery
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Neurosurgery, PainPerioperative Inflammation and Cyclooxygenase 2 (COX-2)
NCT00122096
- Seattle, Washington
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | Perioperative Inflammation and Cyclooxygenase 2 (COX-2) | |||
| Official Title ICMJE | Preoperative Valdecoxib: CNS Penetration and Effects on Biochemical Markers of Pain and Sensitization | |||
| Brief Summary | Surgery initiates a complex cascade of events involving the release of chemical compounds from nerve endings and damaged tissue which leads to an inflammatory and pain response. The purpose of this investigation is to measure various chemical mediators in the blood and cerebrospinal fluid, and to test the hypothesis that they will be decreased in patients treated with a COX-2 inhibitor. | |||
| Detailed Description | Surgery initiates a complex cascade of events involving the release of nociceptive compounds from nerve endings and damaged tissue which leads to an inflammatory and hyperalgesic response. COX-2 inhibitors are often used for treating pain. This is a double-blind randomized study in surgical patients receiving a spinal drain for surgical purposes. The hypothesis is that valdecoxib will reach therapeutic concentrations in CSF, and will decrease plasma and CSF concentrations of inflammatory mediators. Subjects will receive valdecoxib 40 mg or placebo approximately 1 hr prior to surgery. Serial blood and CSF samples will be obtained. Valdecoxib and cytokine concentrations will be measured. | |||
| Study Type ICMJE | Interventional | |||
| Study Phase ICMJE | Phase 4 | |||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Primary Purpose: Treatment | |||
| Condition ICMJE |
| |||
| Intervention ICMJE | Drug: valdecoxib | |||
| Study Arms ICMJE | Not Provided | |||
| Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
| Recruitment Information | ||||
| Recruitment Status ICMJE | Completed | |||
| Enrollment ICMJE | 30 | |||
| Original Enrollment ICMJE | Same as current | |||
| Study Completion Date ICMJE | January 2006 | |||
| Primary Completion Date | Not Provided | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
| Sex/Gender ICMJE |
| |||
| Ages ICMJE | 18 Years to 80 Years (Adult, Older Adult) | |||
| Accepts Healthy Volunteers ICMJE | No | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | United States | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT00122096 | |||
| Other Study ID Numbers ICMJE | EDK001 | |||
| Has Data Monitoring Committee | Not Provided | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement ICMJE | Not Provided | |||
| Responsible Party | Not Provided | |||
| Study Sponsor ICMJE | University of Washington | |||
| Collaborators ICMJE | Pfizer | |||
| Investigators ICMJE |
| |||
| PRS Account | University of Washington | |||
| Verification Date | September 2008 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||