Back to resultsEffect of Valdecoxib Pretreatment on Pain and Secondary Hyperalgesia in Healthy Volunteers
Primary Purpose
Pain, Hyperalgesia
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
valdecoxib
Sponsored by
About this trial
This is an interventional prevention trial for Pain focused on measuring pretreatment, healthy volunteers
Eligibility Criteria
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
Sites / Locations
- Penn State University College of Medicine
Outcomes
Primary Outcome Measures
Reduction in the area of secondary hyperalgesia
Secondary Outcome Measures
Reduction in pain threshold
Reduction in pain unpleasantness
Full Information
NCT ID
NCT00260325
First Posted
November 29, 2005
Last Updated
November 21, 2017
Sponsor
Penn State University
Collaborators
Pfizer, National Institutes of Health (NIH)
1. Study Identification
Unique Protocol Identification Number
NCT00260325
Brief Title
Effect of Valdecoxib Pretreatment on Pain and Secondary Hyperalgesia in Healthy Volunteers
Official Title
Effect of Valdecoxib Pretreatment on Pain and Secondary Hyperalgesia: a Randomized Controlled Trial in Healthy Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
August 2004 (undefined)
Primary Completion Date
April 2006 (Actual)
Study Completion Date
April 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Penn State University
Collaborators
Pfizer, National Institutes of Health (NIH)
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Hyperalgesia
Keywords
pretreatment, healthy volunteers
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
20 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
valdecoxib
Primary Outcome Measure Information:
Title
Reduction in the area of secondary hyperalgesia
Secondary Outcome Measure Information:
Title
Reduction in pain threshold
Title
Reduction in pain unpleasantness
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Piotr K Janicki, MD, PhD
Organizational Affiliation
Penn State University, Dept of Anesthesiology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Penn State University College of Medicine
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Effect of Valdecoxib Pretreatment on Pain and Secondary Hyperalgesia in Healthy Volunteers
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