Effect of Valdecoxib Pretreatment on Pain and Secondary Hyperalgesia in Healthy Volunteers
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...
Brief Summary
Official Title: “Effect of Valdecoxib Pretreatment on Pain and Secondary Hyperalgesia: a Randomized Controlled Trial in Healthy Volunteers”
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: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Prevention
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 Investigator Information
Lead Investigator: Penn State University Other
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 February 12, 2012
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
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00260325
