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...
Date First Received: November 29, 2005
Last Updated: May 29, 2007
Verified by: Penn State University, May 2007
Clinical Trial Phase: Phase 4 | Start Date: August 2004
Overall Status: Completed
Estimated Enrollment: 20
Brief Summary
Official Title: “Effect of Valdecoxib Pretreatment on Pain and Secondary Hyperalgesia: a Randomized Controlled Trial in Healthy Volunteers”
Condition Keyword(s):
Intervention(s):
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.
Study Type: Interventional
Study Design: Prevention, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study
Intervention(s) in this Clinical Trial
- Drug: valdecoxib
Outcome Measures for this Clinical Trial
Primary Measures
- Reduction in the area of secondary hyperalgesia
Secondary Measures
- Reduction in pain threshold
- Reduction in pain unpleasantness
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers
Clinical Trial Sponsor Information
Lead Sponsor: Penn State University
Overall Clinical Trial Officials and Contacts
Piotr K Janicki, MD, PhD Principal Investigator Penn State University, Dept of Anesthesiology
Additional Information
Information obtained from ClinicalTrials.gov on July 02, 2009
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00260325
Study ID Number: 70,328-01
ClinicalTrials.gov Identifier: NCT00260325
Health Authority: United States: Food and Drug Administration
Clinical Trials Authorship and Review
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