Effect of Valdecoxib Pretreatment on Pain and Secondary Hyperalgesia in Healthy Volunteers

NCT00260325

Last updated date
Study Location
Penn State University College of Medicine
Hershey, Pennsylvania, 17033, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pain, Hyperalgesia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- healthy male of non-pregnant female; 18yo or older

- not currently taking NSAID

- able and willing to provide informed consent

- willing to avoid other NSAIDs in 24 hour period following study

- no known hypersentitivites or contraindications to NSAIDS, sulfonomides or capsaicin

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- pregnant or breast feeding


- use of NSAIDS or other analgesic medications in past 7 days


- unwilling or unable to give informed consent


- contraindication to any study medication or other NSAID

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Pain, HyperalgesiaEffect of Valdecoxib Pretreatment on Pain and Secondary Hyperalgesia in Healthy Volunteers
NCT00260325
  1. Hershey, Pennsylvania
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Effect of Valdecoxib Pretreatment on Pain and Secondary Hyperalgesia in Healthy Volunteers
Official Title  ICMJE Effect of Valdecoxib Pretreatment on Pain and Secondary Hyperalgesia: a Randomized Controlled Trial in Healthy Volunteers
Brief Summary Tis study was designed to test the hypothesis that pretreatment with valdecoxib, prior to injury could reduce or prevent the development of secondary hyperalgesia around the area of primary injury. A heat/capsaicin model of induced hyperalgesia was tested in healthy volunteers in a randomized, double blind, cross-over trial of a single dose of 40 mg vadecoxib versus control. Subjects rated pain intesnsity and unpleasantness following heat stimulation of the forearm, the area of hyperalgesia was also mapped over the course of the experiment.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Prevention
Condition  ICMJE
  • Pain
  • Hyperalgesia
Intervention  ICMJE Drug: valdecoxib
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: November 29, 2005)
20
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2006
Actual Primary Completion Date April 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • healthy male of non-pregnant female; 18yo or older
  • not currently taking NSAID
  • able and willing to provide informed consent
  • willing to avoid other NSAIDs in 24 hour period following study
  • no known hypersentitivites or contraindications to NSAIDS, sulfonomides or capsaicin

Exclusion Criteria:

  • pregnant or breast feeding
  • use of NSAIDS or other analgesic medications in past 7 days
  • unwilling or unable to give informed consent
  • contraindication to any study medication or other NSAID
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00260325
Other Study ID Numbers  ICMJE 70,328-01
IIG Pfizer(PJK)
MOIRR10732
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Penn State University
Study Sponsor  ICMJE Penn State University
Collaborators  ICMJE
  • Pfizer
  • National Institutes of Health (NIH)
Investigators  ICMJE
Principal Investigator:Piotr K Janicki, MD, PhDPenn State University, Dept of Anesthesiology
PRS Account Penn State University
Verification Date November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP