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

The Pennsylvania State University (PENNSTATE) logo

The Pennsylvania State University (PENNSTATE)

Status and phase

Completed
Phase 4

Conditions

Hyperalgesia
Pain

Treatments

Drug: valdecoxib

Study type

Interventional

Funder types

Other
Industry
NIH

Identifiers

NCT00260325
IIG Pfizer(PJK)
70,328-01
MOIRR10732

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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