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

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ClinicalTrials.gov Identifier: NCT00260325
Recruitment Status : Completed
First Posted : December 1, 2005
Last Update Posted : November 24, 2017
National Institutes of Health (NIH)
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Pain Hyperalgesia Drug: valdecoxib Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: Effect of Valdecoxib Pretreatment on Pain and Secondary Hyperalgesia: a Randomized Controlled Trial in Healthy Volunteers
Study Start Date : August 2004
Primary Completion Date : April 2006
Study Completion Date : April 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Valdecoxib
U.S. FDA Resources

Primary Outcome Measures :
  1. Reduction in the area of secondary hyperalgesia

Secondary Outcome Measures :
  1. Reduction in pain threshold
  2. Reduction in pain unpleasantness

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00260325

United States, Pennsylvania
Penn State University College of Medicine
Hershey, Pennsylvania, United States, 17033
Sponsors and Collaborators
Penn State University
National Institutes of Health (NIH)
Principal Investigator: Piotr K Janicki, MD, PhD Penn State University, Dept of Anesthesiology

Responsible Party: Penn State University
ClinicalTrials.gov Identifier: NCT00260325     History of Changes
Other Study ID Numbers: 70,328-01
IIG Pfizer(PJK)
First Posted: December 1, 2005    Key Record Dates
Last Update Posted: November 24, 2017
Last Verified: November 2017

Keywords provided by Penn State University:
healthy volunteers

Additional relevant MeSH terms:
Somatosensory Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents