Safety and Efficacy of Celecoxib Versus Naproxen in the 6-Month Treatment of Knee Osteoarthritis - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00643799

Purpose

To compare the safety and efficacy of celecoxib versus naproxen for the treatment of knee osteoarthritis

Condition	Intervention	Phase
Osteoarthritis, Knee	Drug: Celecoxib Drug: Naproxen Drug: Placebo	Phase IV

MedlinePlus related topics: Osteoarthritis

Drug Information available for: Naproxen Naproxen sodium Celecoxib

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Multicenter, Double-Blind, Double-Dummy Study Comparing the Efficacy and Tolerability of Once Daily Celebrex (Celecoxib) and Naproxen 500 mg Twice Daily in the 6-Month Treatment of Subjects With Osteoarthritis of the Knee

Further study details as provided by Pfizer:

Primary Outcome Measures:

Number of responders, defined as a 20% improvement from baseline in the The Western Ontario MacMaster (WOMAC)Questionnaire Total Score [ Time Frame: Month 6 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Number of health care professional contacts [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Patient's and Physician's Satisfaction with Current Arthritis Therapy [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
Change in WOMAC Total Score from baseline [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
Change in WOMAC Subscales from baseline [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
Response in each WOMAC Subscale [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
Change in Medical Outcome Study sleep scale from baseline [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
Laboratory tests [ Time Frame: Month 6 ] [ Designated as safety issue: Yes ]
Vital signs [ Time Frame: Month 6 ] [ Designated as safety issue: Yes ]
Response in VAS [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
Change in Patient's and Physician's Global Assessment of Pain from baseline [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
Change in visual analog scale (VAS) from baseline [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
Adverse events [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]
Change in Gastrointestinal (GI) Distress Scale from Week 1 [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
Change in GI Distress Scale from time of discontinuation of study drug [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
Receipt of prescription or over-the-counter gastroprotective agents or pain medications (off study drug) [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Number of hospitalizations, emergency room visits, and procedures [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Change in Work Limitation Questionnaire scale scores from baseline [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
Physical examination [ Time Frame: Month 6 ] [ Designated as safety issue: Yes ]

Enrollment:	586
Study Start Date:	March 2004
Study Completion Date:	January 2005
Primary Completion Date:	January 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	Drug: Celecoxib 200 mg oral capsule once daily for 6 months
B: Active Comparator	Drug: Naproxen 500 mg oral capsule twice daily for 6 months
C: Placebo Comparator	Drug: Placebo Matched oral placebo for 6 months

Eligibility

Ages Eligible for Study:	40 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Osteoarthritis of the knee as defined by the American College of Rheumatology criteria in a flare state at baseline visit
Functional Capacity Classification of I-III

Exclusion Criteria:

Inflammatory arthritis or gout/pseudo-gout with an acute flare within the past 2 years (subjects with fibrositis or fibromyalgia will not be excluded)
Received acetaminophen within 24 hours of the baseline visit
Acute joint trauma at index joint within the past 3 months with active symptoms
History of gastrointestinal (GI) perforation, obstruction, or bleeding
Diagnosed or treated for GI ulcer within 60 days prior to first dose of study medication
Received corticosteroids or hyaluronic acid within certain timeframe before study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00643799

Show 52 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

No publications provided

Responsible Party:	Pfizer, Inc ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A3191152
Study First Received:	March 18, 2008
Last Updated:	April 22, 2008
ClinicalTrials.gov Identifier:	NCT00643799 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Anti-Inflammatory Agents
Celecoxib
Naproxen
Osteoarthritis
Joint Diseases
Cyclooxygenase Inhibitors
Rheumatic Diseases
Osteoarthritis, Knee

Musculoskeletal Diseases
Analgesics, Non-Narcotic
Arthritis
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents

Additional relevant MeSH terms:

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

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

ClinicalTrials.gov processed this record on May 07, 2009