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ISRCTN
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ISRCTN05282752
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ClinicalTrials.gov identifier
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Public title
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Effect of valdecoxib pretreatment on pain and secondary hyperalgesia associated with the heat/capsaicin model in healthy volunteers
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Scientific title
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Acronym
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N/A
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Serial number at source
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N/A
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Study hypothesis
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Selective COX-2 inhibitors significantly attenuate central sensitization and decrease secondary hyperalgesia
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Lay summary
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Not provided at time of registration
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Ethics approval
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IRB approval at Penn State Hershey Medical Center
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Study design
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Prospective, double blind, randomized, cross-over
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Countries of recruitment
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United States of America
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Disease/condition/study domain
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None (healthy volunteers)
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Participants - inclusion criteria
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Healthy volunteers, both genders
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Participants - exclusion criteria
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Pregnancy, known allergy to COX-2 inhibitors, current infection or treatment with analgesics
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Anticipated start date
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01/01/2004
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Anticipated end date
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01/01/2006
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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40
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Interventions
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Administration of single dose 40 mg valdecoxib or placebo orally (PO).
Measurement of heat/cold pain threshold and area of heat/capsaicin-induced hyperalgesia.
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Primary outcome measure(s)
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Area of secondary hyperalgesia
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Secondary outcome measure(s)
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Pain threshold for cold/heat pain
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Sources of funding
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Independent Investigator Grant from Pfizer Inc.
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Trial website
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Publications
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http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=16529650&query_hl=1&itool=pubmed_DocSum
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Contact name
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Dr
Piotr
Janicki
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Address
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Dept. Anesthesiology
Penn State Hershey Medical Ctr
H187
500 University Drive
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City/town
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Hershey
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Zip/Postcode
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PA 17036
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Country
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United States of America
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Email
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pjanicki@psu.edu
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Sponsor
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Pfizer Inc. (USA)
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Address
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235 E. 42nd Str
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City/town
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New York
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Zip/Postcode
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NY, 10017-5755
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Country
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United States of America
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Email
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maria.mccauley@pfizer.com
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Date applied
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29/11/2005
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Last edited
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16/08/2011
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Date ISRCTN assigned
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30/11/2005
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