To determine whether continuous use of celecoxib over a 6 month period is more effective than intermittent use in preventing spontaneous osteoarthritis flares.

Condition	Intervention	Phase
Osteoarthritis	Drug: Celecoxib	Phase IV

Further Study Details: 

Primary Outcomes: To determine whether continuous use over a 6-month period of celecoxib 200 mg per day is more effective than intermittent use of celecoxib 200 mg per day in preventing spontaneous osteoarthritis flares.
Secondary Outcomes: To evaluate the safety and tolerability of continuous use over a 6-month period of celecoxib 200 mg QD versus "usual use" celecoxib 200mg QD. To assess whether disease management
Expected Total Enrollment:  812

Ages Eligible for Study:  18 Years   -   80 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Subject has been diagnosed with osteoarthritis of the hip or knee and requires NSAID to control pain.

Exclusion Criteria:

• Subject has had surgery on index joint.
• Subject has active GI or cardiovascular disease.

Please refer to this study by ClinicalTrials.gov identifier  NCT00139776

Valerie Marquino      212-733-4483    valerie.marquino@pfizer.com

California
      Pfizer Investigational Site, Tustin,  California,  92780,  United States; Recruiting
      Pfizer Investigational Site, Laguna Hills,  California,  92653,  United States; Recruiting
      Pfizer Investigational Site, Paramount,  California,  90723,  United States; Recruiting
      Pfizer Investigational Site, Long Beach,  California,  90806,  United States; Recruiting
Florida
      Pfizer Investigational Site, Tampa,  Florida,  33614-7118,  United States; Recruiting
      Pfizer Investigational Site, Miami,  Florida,  33173,  United States; Recruiting
Georgia
      Pfizer Investigational Site, Decatur,  Georgia,  30033,  United States; Recruiting
Kentucky
      Pfizer Investigational Site, Lexington,  Kentucky,  40509,  United States; Recruiting
      Pfizer Investigational Site, Madisonville,  Kentucky,  42431,  United States; Recruiting
Maryland
      Pfizer Investigational Site, Baltimore,  Maryland,  21218,  United States; Recruiting
Nevada
      Pfizer Investigational Site, Las Vegas,  Nevada,  89106,  United States; Recruiting
New York
      Pfizer Investigational Site, Manlius,  New York,  13104,  United States; Recruiting
      Pfizer Investigational Site, Great Neck,  New York,  11021,  United States; Recruiting
      Pfizer Investigational Site, Rochester,  New York,  14609,  United States; Recruiting
Ohio
      Pfizer Investigational Site, Cleveland,  Ohio,  44122,  United States; Recruiting
      Pfizer Investigational Site, Zanesville,  Ohio,  43701,  United States; Recruiting
Pennsylvania
      Pfizer Investigational Site, Duncansville,  Pennsylvania,  16635-0909,  United States; Recruiting
      Pfizer Investigational Site, Johnstown,  Pennsylvania,  15904,  United States; Recruiting
      Pfizer Investigational Site, Beaver,  Pennsylvania,  15009,  United States; Recruiting
      Pfizer Investigational Site, Camp Hill,  Pennsylvania,  17011,  United States; Recruiting
Tennessee
      Pfizer Investigational Site, Johnson City,  Tennessee,  37601,  United States; Recruiting
Texas
      Pfizer Investigational Site, Dallas,  Texas,  75235,  United States; Recruiting
Wisconsin
      Pfizer Investigational Site, Milwaukee,  Wisconsin,  53209,  United States; Recruiting

Study chairs or principal investigators

Pfizer Call Center,  Study Director,  Pfizer   

Study ID Numbers:  A3191173
Last Updated:  August 30, 2005
Record first received:  August 29, 2005
ClinicalTrials.gov Identifier:  NCT00139776
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-06