Effect of valdecoxib pretreatment on pain and secondary hyperalgesia associated with the heat/capsaicin model in healthy volunteers

ISRCTN	ISRCTN05282752
DOI	https://doi.org/10.1186/ISRCTN05282752
ClinicalTrials.gov (NCT)	NCT00260325
Protocol serial number	N/A
Sponsor	Pfizer Inc. (USA)
Funder	Independent Investigator Grant from Pfizer Inc.

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Piotr Janicki
Scientific

Penn State Hershey Medical Ctr
Dept. Anesthesiology
H187
500 University Drive
Hershey
PA 17036
United States of America

Email	pjanicki@psu.edu

Primary study design	Interventional
Study design	Prospective, double blind, randomized, cross-over
Secondary study design	Randomised controlled trial
Scientific title	Effect of valdecoxib pretreatment on pain and secondary hyperalgesia associated with the heat/capsaicin model in healthy volunteers
Study objectives	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
Health condition(s) or problem(s) studied	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
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	valdecoxib
Primary outcome measure(s)	Area of secondary hyperalgesia
Key secondary outcome measure(s)	Pain threshold for cold/heat pain
Completion date	01/01/2006

Participant type(s)	Healthy volunteer
Age group	Adult
Sex	All
Target sample size at registration	40
Key inclusion criteria	Healthy volunteers, both genders
Key exclusion criteria	Pregnancy, known allergy to COX-2 inhibitors, current infection or treatment with analgesics
Date of first enrolment	01/01/2004
Date of final enrolment	01/01/2006

Penn State Hershey Medical Ctr

Dept. Anesthesiology
Hershey
PA 17036
United States of America

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	10/03/2006		Yes	No

03/10/2017: internal review.