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NCT00194090 Clinical Trial

Efficacy of Celecoxib vs Placebo to Prevent Pain in a Paced Walk

Knee Osteoarthritis Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00194090
Other study ID # 06-04-41
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date June 2004
Est. completion date September 1, 2005

Study information
Verified date August 2022
Source University Hospitals Cleveland Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date September 1, 2005
Est. primary completion date September 1, 2005
Accepts healthy volunteers No
Gender All
Age group 45 Years to 85 Years
Eligibility 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 -

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• celecoxib

Locations
Country Name City State
United States University Hospitals of Cleveland Cleveland Ohio

Sponsors (2)
Lead Sponsor Collaborator
University Hospitals Cleveland Medical Center Pfizer

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary time to onset of severe pain
Secondary time to onset of moderate pain
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