NCT00122096

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Nov 2002

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2002

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

July 18, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 21, 2005

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2006

Completed
Last Updated

September 26, 2008

Status Verified

September 1, 2008

First QC Date

July 18, 2005

Last Update Submit

September 25, 2008

Conditions

NeurosurgeryPain

Keywords

neurosurgeryCOX-2inflammationpain

Outcome Measures

Primary Outcomes (1)

  • Cerebrospinal fluid (CSF) valdecoxib concentration

Secondary Outcomes (5)

  • Plasma valdecoxib concentration

  • CSF/plasma valdecoxib concentration ratio

  • CSF and plasma cytokine concentrations

  • Postoperative opioid consumption

  • Pain visual analogue scale (VAS) scores

Interventions

valdecoxibDRUG

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing surgery requiring lumbar drain placement

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Washington

Seattle, Washington, 98195, United States

Location

MeSH Terms

Conditions

PainInflammation

Interventions

valdecoxib

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPathologic Processes

Study Officials

  • Evan Kharasch, MD PhD

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 18, 2005

First Posted

July 21, 2005

Study Start

November 1, 2002

Study Completion

January 1, 2006

Last Updated

September 26, 2008

Record last verified: 2008-09

Locations

US(1)