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: Prevention, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study

Primary:

• Reduction in the area of secondary hyperalgesia

Secondary:

• Reduction in pain threshold
• Reduction in pain unpleasantness

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

Lead Sponsor: Penn State University

Penn State University College of Medicine

Hershey Pennsylvania 17033 United States

Overall Clinical Trial Officials and Contacts

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

Information obtained from ClinicalTrials.gov on July 18, 2008

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