NCT00260325

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_4 pain

Timeline
Completed

Started Aug 2004

Typical duration for phase_4 pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2004

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

November 29, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 1, 2005

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2006

Completed
Last Updated

November 24, 2017

Status Verified

November 1, 2017

Enrollment Period

1.7 years

First QC Date

November 29, 2005

Last Update Submit

November 21, 2017

Conditions

PainHyperalgesia

Keywords

pretreatmenthealthy volunteers

Outcome Measures

Primary Outcomes (1)

  • Reduction in the area of secondary hyperalgesia

Secondary Outcomes (2)

  • Reduction in pain threshold

  • Reduction in pain unpleasantness

Interventions

valdecoxibDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Penn State University College of Medicine

Hershey, Pennsylvania, 17033, United States

Location

MeSH Terms

Conditions

PainHyperalgesia

Interventions

valdecoxib

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSomatosensory DisordersSensation DisordersNervous System Diseases

Study Officials

  • Piotr K Janicki, MD, PhD

    Penn State University, Dept of Anesthesiology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 29, 2005

First Posted

December 1, 2005

Study Start

August 1, 2004

Primary Completion

April 1, 2006

Study Completion

April 1, 2006

Last Updated

November 24, 2017

Record last verified: 2017-11

Locations

US(1)