Condition category
Signs and Symptoms
Date applied
29/11/2005
Date assigned
30/11/2005
Last edited
03/10/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

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 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

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

Hospitals

Trial 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

Phase

Not Applicable

Drug names

valdecoxib

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

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

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

2006 results in: https://www.ncbi.nlm.nih.gov/pubmed/?term=16529650

Publication citations

  1. Results

    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.

Additional files

Editorial Notes

03/10/2017: internal review.