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NCT00260325 Clinical Trial

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

Pain Clinical Trial

Official title:
Effect of Valdecoxib Pretreatment on Pain and Secondary Hyperalgesia: a Randomized Controlled Trial in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00260325
Other study ID # 70,328-01
Secondary ID IIG Pfizer(PJK)M
Status Completed
Phase Phase 4
First received November 29, 2005
Last updated November 21, 2017
Start date August 2004
Est. completion date April 2006

Study information
Verified date November 2017
Source Penn State University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date April 2006
Est. primary completion date April 2006
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• valdecoxib

Locations
Country Name City State
United States Penn State University College of Medicine Hershey Pennsylvania

Sponsors (3)
Lead Sponsor Collaborator
Penn State University National Institutes of Health (NIH), Pfizer

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Reduction in the area of secondary hyperalgesia
Secondary Reduction in pain threshold
Secondary Reduction in pain unpleasantness
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