Study Of "Continuous Use" Of Celecoxib Vs. "Usual or Intermittent Use" - Full Text View

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00139776

Purpose

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.

Condition	Intervention	Phase
Osteoarthritis, Knee Osteoarthritis, Hip	Drug: Celecoxib	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Osteoarthritis

Drug Information available for: Celecoxib

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Number of Flare Events Per Time of Exposure to Study Medication [ Time Frame: Period III (22 weeks) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Time to Occurrence of First Osteoarthritis (OA) Flare [ Time Frame: Period III (22 weeks) ] [ Designated as safety issue: No ]
Proportion of Days Free From Osteoarthritis (OA) Flare [ Time Frame: Period III (22 weeks) ] [ Designated as safety issue: No ]
Proportion of Days in Osteoarthritis (OA) Flare [ Time Frame: Period III (22 weeks) ] [ Designated as safety issue: No ]
Arthritis Pain Numerical Rating Scale (NRS) [ Time Frame: Period III ] [ Designated as safety issue: No ]
Patient's Global Assessment of Arthritis [ Time Frame: Period III ] [ Designated as safety issue: No ]
Physician's Global Assessment of Arthritis at Final Visit [ Time Frame: Period III (22 weeks) ] [ Designated as safety issue: No ]
Total Rescue Medication Taken (Mean) [ Time Frame: Period III (22 weeks) ] [ Designated as safety issue: No ]
Proportion of Days on Rescue Medication [ Time Frame: Period III (22 weeks) ] [ Designated as safety issue: No ]
Days on Flare Medication [ Time Frame: Period III (22 weeks) ] [ Designated as safety issue: No ]
Change in Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Scores [ Time Frame: Period III (22 weeks) ] [ Designated as safety issue: No ]
Area Under the Curve (AUCs) of Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Scores [ Time Frame: Period III (22 weeks) ] [ Designated as safety issue: No ]

Enrollment:	875
Study Start Date:	July 2005
Study Completion Date:	February 2008
Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Celecoxib - Continuous use: Active Comparator	Drug: Celecoxib 24 weeks of study treatment: 2 weeks open-label celecoxib 200 mg daily followed by 22 weeks of randomized double blind celecoxib 200 mg daily. Placebo used as flare medication when directed.
Celecoxib - Intermittent use: Active Comparator	Drug: Celecoxib 24 weeks of study treatment: 2 weeks open-label celecoxib 200 mg daily followed by 22 weeks of randomized double blind placebo daily. Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00139776

Show 124 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Link to ClinicalStudyResults.org posting: This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A3191173
Study First Received:	August 29, 2005
Results First Received:	February 20, 2009
Last Updated:	June 24, 2009
ClinicalTrials.gov Identifier:	NCT00139776 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

Chronic treatment osteoarthritis, Celecoxib, Continuous Use, Intermittent Use

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Celecoxib
Molecular Mechanisms of Pharmacological Action
Osteoarthritis
Joint Diseases
Physiological Effects of Drugs
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Osteoarthritis, Hip
Rheumatic Diseases
Pharmacologic Actions

Osteoarthritis, Knee
Musculoskeletal Diseases
Sensory System Agents
Analgesics, Non-Narcotic
Arthritis
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Peripheral Nervous System Agents
Analgesics
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 25, 2009