Contact information
Type
Scientific
Contact name
Dr Piotr Janicki
ORCID ID
Contact details
Penn State Hershey Medical Ctr
Dept. Anesthesiology
H187
500 University Drive
Hershey
PA 17036
United States of America
-
pjanicki@psu.edu
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
NCT00260325
Protocol/serial number
N/A
Study information
Scientific title
Effect of valdecoxib pretreatment on pain and secondary hyperalgesia associated with the heat/capsaicin model in healthy volunteers
Acronym
Study hypothesis
Selective COX-2 inhibitors significantly attenuate central sensitization and decrease secondary hyperalgesia: a randomised clinical trial
Ethics approval(s)
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
Study setting(s)
Hospital
Study type
Treatment
Patient information sheet
Condition
Hyperalgesia
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
Drug
Pharmaceutical study type(s)
Phase
Not Applicable
Drug/device/biological/vaccine name(s)
valdecoxib
Primary outcome measure
Area of secondary hyperalgesia
Secondary outcome measures
Pain threshold for cold/heat pain
Overall study start date
01/01/2004
Overall study end date
01/01/2006
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Healthy volunteers, both genders
Participant type(s)
Healthy volunteer
Age group
Adult
Sex
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
Study participating centre
Penn State Hershey Medical Ctr
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
ROR
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
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 10/03/2006 | Yes | No |