Effect of Valdecoxib Pretreatment on Pain and Secondary Hyperalgesia in Healthy Volunteers
Phase 4
Completed
- Conditions
- PainHyperalgesia
- Registration Number
- NCT00260325
- Lead Sponsor
- Penn State University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Reduction in the area of secondary hyperalgesia
- Secondary Outcome Measures
Name Time Method Reduction in pain unpleasantness Reduction in pain threshold
Trial Locations
- Locations (1)
Penn State University College of Medicine
🇺🇸Hershey, Pennsylvania, United States