Perioperative Inflammation and Cyclooxygenase 2 (COX-2)

NCT00122096

Last updated date
Study Location
University of Washington
Seattle, Washington, 98195, United States
Contact
1-800-718-1021

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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
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
  1. 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
  • Neurosurgery
  • Pain
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
 (submitted: July 18, 2005)
30
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE January 2006
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients undergoing surgery requiring lumbar drain placement

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
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
Principal Investigator:Evan Kharasch, MD PhDWashington University School of Medicine
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