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Effect of Valdecoxib Pretreatment on Pain and Secondary Hyperalgesia in Healthy Volunteers

Sponsor
Penn State University (Other)
Overall Status
Completed
CT.gov ID
NCT00260325
Collaborator
Pfizer (Industry), National Institutes of Health (NIH) (NIH)
20
Enrollment
1
Location
20
Duration (Months)
1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Tis study was designed to test the hypothesis that pretreatment with valdecoxib, prior to injury could reduce or prevent the development of secondary hyperalgesia around the area of primary injury. A heat/capsaicin model of induced hyperalgesia was tested in healthy volunteers in a randomized, double blind, cross-over trial of a single dose of 40 mg vadecoxib versus control. Subjects rated pain intesnsity and unpleasantness following heat stimulation of the forearm, the area of hyperalgesia was also mapped over the course of the experiment.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double
Primary Purpose:
Prevention
Official Title:
Effect of Valdecoxib Pretreatment on Pain and Secondary Hyperalgesia: a Randomized Controlled Trial in Healthy Volunteers
Study Start Date :
Aug 1, 2004
Actual Primary Completion Date :
Apr 1, 2006
Actual Study Completion Date :
Apr 1, 2006

Outcome Measures

Primary Outcome Measures

  1. Reduction in the area of secondary hyperalgesia []

Secondary Outcome Measures

  1. Reduction in pain threshold []

  2. Reduction in pain unpleasantness []

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  • healthy male of non-pregnant female; 18yo or older

  • not currently taking NSAID

  • able and willing to provide informed consent

  • willing to avoid other NSAIDs in 24 hour period following study

  • no known hypersentitivites or contraindications to NSAIDS, sulfonomides or capsaicin

Exclusion Criteria:

  • pregnant or breast feeding

  • use of NSAIDS or other analgesic medications in past 7 days

  • unwilling or unable to give informed consent

  • contraindication to any study medication or other NSAID

Contacts and Locations

Locations

Site City State Country Postal Code
1 Penn State University College of Medicine Hershey Pennsylvania United States 17033

Sponsors and Collaborators

  • Penn State University
  • Pfizer
  • National Institutes of Health (NIH)

Investigators

  • Principal Investigator: Piotr K Janicki, MD, PhD, Penn State University, Dept of Anesthesiology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Penn State University
ClinicalTrials.gov Identifier:
NCT00260325
Other Study ID Numbers:
  • 70,328-01
  • IIG Pfizer(PJK)
  • MOIRR10732
First Posted:
Dec 1, 2005
Last Update Posted:
Nov 24, 2017
Last Verified:
Nov 1, 2017
Keywords provided by Penn State University
pretreatment
healthy volunteers
Additional relevant MeSH terms:
Hyperalgesia
Valdecoxib

Study Results

No Results Posted as of Nov 24, 2017