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

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ClinicalTrials.gov Identifier: NCT00194090
Recruitment Status : Unknown
Verified July 2004 by University Hospitals Cleveland Medical Center.
Recruitment status was:  Recruiting
First Posted : September 19, 2005
Last Update Posted : September 19, 2005
Sponsor:
Collaborator:
Pfizer
Information provided by:
University Hospitals Cleveland Medical Center

Tracking Information
First Submitted Date  ICMJE September 13, 2005
First Posted Date  ICMJE September 19, 2005
Last Update Posted Date September 19, 2005
Study Start Date  ICMJE June 2004
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
time to onset of severe pain
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
time to onset of moderate pain
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of Celecoxib Vs Placebo to Prevent Pain in a Paced Walk
Official Title  ICMJE 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
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Knee Osteoarthritis
Intervention  ICMJE Drug: celecoxib
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 Unknown status
Enrollment  ICMJE
 (submitted: September 13, 2005)
40
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE September 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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 -

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 45 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
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 NCT00194090
Other Study ID Numbers  ICMJE 06-04-41
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE University Hospitals Cleveland Medical Center
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator: Michele M Hooper, MD, MS University Hospitals Cleveland Medical Center
PRS Account University Hospitals Cleveland Medical Center
Verification Date July 2004

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