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Clinical Trials/NCT00194090
NCT00194090CompletedPhase 4

A Double-blind, Placebo-controlled, Crossover Pilot Study of the Efficacy of Celecoxib 200 mg qd in Relieving Pain and Walking Dysfunction in Osteoarthritis of the Knee

University Hospitals Cleveland Medical Center1 site in 1 country40 target enrollmentStarted: June 1, 2004Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 4
Status
Completed
Enrollment
40
Locations
1
Primary Endpoint
time to onset of severe pain
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

A paced 20-minute walk is a reproducible model for acute pain in knee osteoarthritis

Detailed Description

This is a randomizd, placbo-controlled, crossover trial comparing a single dose of celecoxib to placebo measuring the time to onset of acute pain in a paced 20-minute walk.

40 subjects will be enrolled

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Treatment
Masking
Double

Eligibility Criteria

Ages
45 Years to 85 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Knee osteoarthritis by ACR clinical criteria Pain of at least 40 mm by VAS at baseline

Exclusion Criteria

  • •Non-pregant, non-lactating Able to stop active arthritis medication for washout Cardiovascular risk factors Abnormal EKG -

Outcomes

Primary Outcomes

time to onset of severe pain

Secondary Outcomes

  • time to onset of moderate pain

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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