Clinical trial NCT00139776: Study Of "Continuous Use" Of Celecoxib Vs. "Usual or Intermittent Use"
Official title: Double-Blind Parallel-Group Randomized Study Of Efficacy And Safety Of "Continuous Use" Of Celecoxib Vs. The "Usual Use" Of Celecoxib In The Treatment Of Subjects With Chronic Osteoarthritis Of The Hip Or Knee Who Require an Anti-inflammatory Medication for Control Of Their Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Osteoarthritis, Knee
Osteoarthritis, Hip
Keywords: Chronic treatment osteoarthritis, Celecoxib, Continuous Use, Intermittent Use
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-08-31
Enrollment: 875
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To determine whether "continuous use" of celecoxib over a 6-month period is more efficacious than "usual or intermittent use" in preventing spontaneous osteoarthritis flares of the knee and hip.


Eligibility criteria: Inclusion Criteria:

* Subject has been diagnosed, according to American College of Rheumatology guidelines, with osteoarthritis of the hip or knee and requires non-steroidal anti-inflammatory drugs (NSAIDs) to control their osteoarthritis pain and have access to a touch-tone telephone.

Exclusion Criteria:

* Subject has had surgery on index joint.
* Subject has history of rheumatoid arthritis or fibromyalgia syndrome.
* Subject has active gastrointestinal or cardiovascular disease.

Primary outcomes:
measure: Number of Flare Events Per Time of Exposure to Study Medication
timeFrame: Period III (22 weeks)
Secondary outcomes:
measure: Time to Occurrence of First Osteoarthritis (OA) Flare
timeFrame: Period III (22 weeks)
measure: Proportion of Days Free From Osteoarthritis (OA) Flare
timeFrame: Period III (22 weeks)
measure: Proportion of Days in Osteoarthritis (OA) Flare
timeFrame: Period III (22 weeks)
measure: Arthritis Pain Numerical Rating Scale (NRS)
timeFrame: Period III
measure: Patient's Global Assessment of Arthritis
timeFrame: Period III
measure: Physician's Global Assessment of Arthritis at Final Visit
timeFrame: Period III (22 weeks)
measure: Total Rescue Medication Taken (Mean)
timeFrame: Period III (22 weeks)
measure: Proportion of Days on Rescue Medication
timeFrame: Period III (22 weeks)
measure: Days on Flare Medication
timeFrame: Period III (22 weeks)
measure: Change in Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Scores
timeFrame: Period III (22 weeks)
measure: Area Under the Curve (AUCs) of Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Scores
timeFrame: Period III (22 weeks)
Other outcomes:
measure: Change in Medical Outcomes Study Sleep Scale - All Assessments
timeFrame: Period III
measure: Medical Outcomes Study Sleep Scale - Number of Participants With Optimal, Mixed and Not Optimal Sleep
timeFrame: Period III
measure: Change in the Quality of Life Short Form-12v2 (SF-12v2) Scale Scores - All Assessments
timeFrame: Period III
measure: Serious Adverse Events in Open Label run-in Period
timeFrame: 2 weeks prior to double blind dosing
Locations:
city: Huntsville
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Peoria
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Phoenix
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Anaheim
country: United States
facility: Pfizer Investigational Site
state: California
city: Huntington Beach
country: United States
facility: Pfizer Investigational Site
state: California
city: Long Beach
country: United States
facility: Pfizer Investigational Site
state: California
city: Orange
country: United States
facility: Pfizer Investigational Site
state: California
city: Paramount
country: United States
facility: Pfizer Investigational Site
state: California
city: Stockton
country: United States
facility: Pfizer Investigational Site
state: California
city: Tustin
country: United States
facility: Pfizer Investigational Site
state: California
city: Walnut Creek
country: United States
facility: Pfizer Investigational Site
state: California
city: Whittier
country: United States
facility: Pfizer Investigational Site
state: California
city: Wheat Ridge
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Danbury
country: United States
facility: Pfizer Investigational Site
state: Connecticut
city: New Milford
country: United States
facility: Pfizer Investigational Site
state: Connecticut
city: Waterbury
country: United States
facility: Pfizer Investigational Site
state: Connecticut
city: Ocala
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Palm Harbor
country: United States
facility: Pfizer Investigational Site
state: Florida
city: South Miami
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Tampa
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Zephyrhills
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Decatur
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Springfield
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Dubuque
country: United States
facility: Pfizer Investigational Site
state: Iowa
city: Dubuque
country: United States
facility: Pfizer Investigational Site
state: Iowa
city: Lexington
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Madisonville
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Baltimore
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Clinton
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Frederick
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Greenbelt
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Wheaton
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Brockton
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Jefferson City
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Jefferson City
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Springfield
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Lincoln
country: United States
facility: Pfizer Investigational Site
state: Nebraska
city: Omaha
country: United States
facility: Pfizer Investigational Site
state: Nebraska
city: Las Vegas
country: United States
facility: Pfizer Investigational Site
state: Nevada
city: Las Vegas
country: United States
facility: Pfizer Investigational Site
state: Nevada
city: Great Neck
country: United States
facility: Pfizer Investigational Site
state: New York
city: Manlius
country: United States
facility: Pfizer Investigational Site
state: New York
city: Mineola
country: United States
facility: Pfizer Investigational Site
state: New York
city: New York
country: United States
facility: Pfizer Investigational Site
state: New York
city: Rochester
country: United States
facility: Pfizer Investigational Site
state: New York
city: Winston-Salem
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Cleveland
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Columbus
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Zanesville
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Eugene
country: United States
facility: Pfizer Investigational Site
state: Oregon
city: Beaver
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Camp Hill
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Duncansville
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Johnstown
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Johnson City
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Knoxville
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: New Tazewell
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Arlington
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Renton
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Tacoma
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Yakima
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Yakima
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Milwaukee
country: United States
facility: Pfizer Investigational Site
state: Wisconsin
city: Ham
country: Belgium
facility: Pfizer Investigational Site
city: Liege
country: Belgium
facility: Pfizer Investigational Site
city: Porto Alegre
country: Brazil
facility: Pfizer Investigational Site
state: RS
city: Porto Alegre
country: Brazil
facility: Pfizer Investigational Site
state: RS
city: Campinas
country: Brazil
facility: Pfizer Investigational Site
state: SP
city: São Paulo
country: Brazil
facility: Pfizer Investigational Site
state: SP
city: Calgary
country: Canada
facility: Pfizer Investigational Site
state: Alberta
city: Vancouver
country: Canada
facility: Pfizer Investigational Site
state: British Columbia
city: St. John's
country: Canada
facility: Pfizer Investigational Site
state: Newfoundland and Labrador
city: St. John's
country: Canada
facility: Pfizer Investigational Site
state: Newfoundland and Labrador
city: St. John's
country: Canada
facility: Pfizer Investigational Site
state: Newfoundland and Labrador
city: Corunna
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Hamilton
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: London
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Newmarket
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: North York
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Sarnia
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Windsor
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Charlottetown
country: Canada
facility: Pfizer Investigational Site
state: Prince Edward Island
city: Montague
country: Canada
facility: Pfizer Investigational Site
state: Prince Edward Island
city: Mirabel
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Montreal
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Rimouski
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Sherbrooke
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Ste-Foy
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Saskatoon
country: Canada
facility: Pfizer Investigational Site
state: Saskatchewan
city: Santiago
country: Chile
facility: Pfizer Investigational Site
state: RM
city: Viña Del Mar
country: Chile
facility: Pfizer Investigational Site
state: V Region
city: Rancagua
country: Chile
facility: Pfizer Investigational Site
state: VI Región
city: Bogota
country: Colombia
facility: Pfizer Investigational Site
state: Cundinamarca
city: Barranquila
country: Colombia
facility: Pfizer Investigational Site
city: Bogota
country: Colombia
facility: Pfizer Investigational Site
city: Bucaramanga
country: Colombia
facility: Pfizer Investigational Site
city: Joue Les Tours
country: France
facility: Pfizer Investigational Site
city: L'Union
country: France
facility: Pfizer Investigational Site
city: Poitiers
country: France
facility: Pfizer Investigational Site
city: Tours
country: France
facility: Pfizer Investigational Site
city: Randalstown
country: United Kingdom
facility: Pfizer Investigational Site
state: Co Antrim
city: Newtownabbey
country: United Kingdom
facility: Pfizer Investigational Site
state: Co.Antrim
city: Leslie
country: United Kingdom
facility: Pfizer Investigational Site
state: Fife
city: Watford
country: United Kingdom
facility: Pfizer Investigational Site
state: Herts
city: Canterbury
country: United Kingdom
facility: Pfizer Investigational Site
state: Kent
city: Wigan
country: United Kingdom
facility: Pfizer Investigational Site
state: Lancs
city: Bradwell Common
country: United Kingdom
facility: Pfizer Investigational Site
state: Milton Keynes
city: Greenisland, Carrickfergus
country: United Kingdom
facility: Pfizer Investigational Site
state: Northern Ireland
city: Barry
country: United Kingdom
facility: Pfizer Investigational Site
state: Vale Of Glamorgan
city: Pound Hill, Crawley
country: United Kingdom
facility: Pfizer Investigational Site
state: West Sussex
city: Bradford on Avon
country: United Kingdom
facility: Pfizer Investigational Site
state: Wiltshire
city: Midsomer Norton
country: United Kingdom
facility: Pfizer Investigational Site
state: Wiltshire
city: Bangor
country: United Kingdom
facility: Pfizer Investigational Site
city: Bath
country: United Kingdom
facility: Pfizer Investigational Site
city: Belfast
country: United Kingdom
facility: Pfizer Investigational Site
city: Blackpool
country: United Kingdom
facility: Pfizer Investigational Site
city: Cardiff
country: United Kingdom
facility: Pfizer Investigational Site
city: Cookstown
country: United Kingdom
facility: Pfizer Investigational Site
city: Trowbridge
country: United Kingdom
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Strand V, Simon LS, Dougados M, Sands GH, Bhadra P, Breazna A, Immitt J. Treatment of osteoarthritis with continuous versus intermittent celecoxib. J Rheumatol. 2011 Dec;38(12):2625-34. doi: 10.3899/jrheum.110636. Epub 2011 Nov 1.