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Completed

NCT Number: NCT00260325

Effect of Valdecoxib Pretreatment on Pain and Secondary Hyperalgesia 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.

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Key information

Conditions

Pain Hyperalgesia Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Somatosensory Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Penn State University College of Medicine

Hershey, Pennsylvania, 17033, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

valdecoxib

Drug

Primary outcomes

  1. Reduction in the area of secondary hyperalgesia

Secondary outcomes

  1. Reduction in pain threshold

  2. Reduction in pain unpleasantness

Sponsors and collaborators

Lead sponsor

Penn State University

Other

Collaborators

  • National Institutes of Health (NIH)
  • Pfizer

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2006
Study completion
2006
First posted
Dec 1, 2005
Registry last updated
Nov 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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