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 number | NCT00260325 |
| Secondary identifying numbers | N/A |
- Submission date
- 29/11/2005
- Registration date
- 30/11/2005
- Last edited
- 03/10/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Piotr Janicki
Scientific
Scientific
Penn State Hershey Medical Ctr
Dept. Anesthesiology
H187
500 University Drive
Hershey
PA 17036
United States of America
| pjanicki@psu.edu |
Study information
| 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 |
| 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 |
| 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 |
| Completion date | 01/01/2006 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 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 |
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
Hershey
PA 17036
United States of America
Sponsor information
Pfizer Inc. (USA)
Industry
Industry
235 E. 42nd Str
New York
NY, 10017-5755
United States of America
| maria.mccauley@pfizer.com | |
"ROR" |
https://ror.org/01xdqrp08 |
Funders
Funder type
Industry
Independent Investigator Grant from Pfizer Inc.
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 10/03/2006 | Yes | No |
Editorial Notes
03/10/2017: internal review.
