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

This study has been completed.
Sponsor:
Collaborators:
Pfizer
Information provided by:
Penn State University
ClinicalTrials.gov Identifier:
NCT00260325
First received: November 29, 2005
Last updated: May 29, 2007
Last verified: May 2007
  Purpose

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 Intervention Phase
Pain
Hyperalgesia
Drug: valdecoxib
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Effect of Valdecoxib Pretreatment on Pain and Secondary Hyperalgesia: a Randomized Controlled Trial in Healthy Volunteers

Resource links provided by NLM:


Further study details as provided by Penn State University:

Primary Outcome Measures:
  • Reduction in the area of secondary hyperalgesia

Secondary Outcome Measures:
  • Reduction in pain threshold
  • Reduction in pain unpleasantness

Estimated Enrollment: 20
Study Start Date: August 2004
Estimated Study Completion Date: December 2004
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00260325

Locations
United States, Pennsylvania
Penn State University College of Medicine
Hershey, Pennsylvania, United States, 17033
Sponsors and Collaborators
Penn State University
Pfizer
Investigators
Principal Investigator: Piotr K Janicki, MD, PhD Penn State University, Dept of Anesthesiology
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00260325     History of Changes
Other Study ID Numbers: 70,328-01, IIG Pfizer(PJK), MOIRR10732
Study First Received: November 29, 2005
Last Updated: May 29, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Penn State University:
pretreatment
healthy volunteers

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

ClinicalTrials.gov processed this record on September 18, 2014