Contact information
Type
Scientific
Primary contact
Dr Piotr Janicki
ORCID ID
Contact details
Dept. Anesthesiology
Penn State Hershey Medical Ctr
H187
500 University Drive
Hershey
PA 17036
United States of America
pjanicki@psu.edu
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
Selective COX-2 inhibitors significantly attenuate central sensitization and decrease secondary hyperalgesia
Ethics approval
IRB approval at Penn State Hershey Medical Center
Study design
Prospective, double blind, randomized, cross-over
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
None (healthy volunteers)
Intervention
Administration of single dose 40 mg valdecoxib or placebo orally (PO).
Measurement of heat/cold pain threshold and area of heat/capsaicin-induced hyperalgesia.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Area of secondary hyperalgesia
Secondary outcome measures
Pain threshold for cold/heat pain
Overall trial start date
01/01/2004
Overall trial end date
01/01/2006
Reason abandoned
Eligibility
Participant inclusion criteria
Healthy volunteers, both genders
Participant type
Healthy volunteer
Age group
Adult
Gender
Both
Target number of participants
40
Participant exclusion criteria
Pregnancy, known allergy to COX-2 inhibitors, current infection or treatment with analgesics
Recruitment start date
01/01/2004
Recruitment end date
01/01/2006
Locations
Countries of recruitment
United States of America
Trial participating centre
Dept. Anesthesiology
Hershey
PA 17036
United States of America
Sponsor information
Organisation
Pfizer Inc. (USA)
Sponsor details
235 E. 42nd Str
New York
NY
10017-5755
United States of America
maria.mccauley@pfizer.com
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Independent Investigator Grant from Pfizer Inc.
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
Publication citations
-
Burns D, Hill L, Essandoh M, Jarzembowski TM, Schuler HG, Janicki PK, Effect of valdecoxib pretreatment on pain and secondary hyperalgesia: a randomized controlled trial in healthy volunteers [ISRCTN05282752, NCT00260325]., BMC Anesthesiol, 2006, 6, 3, doi: 10.1186/1471-2253-6-3.