Efficacy and Safety of Celecoxib Versus Ibuprofen in the Treatment of Osteoarthritis of the Knee (United States) - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00620867

Purpose

To compare the efficacy and safety of celecoxib versus ibuprofen in subjects with osteoarthritis (OA) of the knee.

Condition	Intervention	Phase
Osteoarthritis, Knee	Drug: Ibuprofen Drug: celecoxib Other: placebo	Phase IV

MedlinePlus related topics: Osteoarthritis

Drug Information available for: Ibuprofen Dexibuprofen Celecoxib

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
Official Title:	A Study of the Efficacy and Tolerability of Once Daily Celebrex (Celecoxib) and Three Times Daily Ibuprofen vs. Placebo in the Treatment of Subjects With Osteoarthritis of the Knee

Further study details as provided by Pfizer:

Primary Outcome Measures:

Change from baseline in patient's assessment of arthritis pain according to visual analogue scale (VAS) [ Time Frame: Week 6 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Vital signs [ Time Frame: Weeks 2 and 6 ] [ Designated as safety issue: Yes ]
Physical examination [ Time Frame: Week 6 ] [ Designated as safety issue: Yes ]
Laboratory test results [ Time Frame: Week 6 ] [ Designated as safety issue: Yes ]
Adverse events [ Time Frame: Weeks 2 and 6 ] [ Designated as safety issue: Yes ]
Change from baseline in patient's and physician's global assessment of pain [ Time Frame: Weeks 2 and 6 ] [ Designated as safety issue: No ]
Pain Satisfaction Scale [ Time Frame: Days 1-7 ] [ Designated as safety issue: No ]
Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
Patient Health Questionnaire (PHQ-9) [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
Change from baseline in patient's assessment of arthritis pain according to VAS [ Time Frame: Week 2 ] [ Designated as safety issue: No ]

Enrollment:	393
Study Start Date:	October 2002
Study Completion Date:	March 2003
Primary Completion Date:	March 2003 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Ibuprofen: Experimental	Drug: Ibuprofen 800 mg oral tablet three time daily with meals for 6 weeks
Celecoxib: Experimental	Drug: celecoxib 200 mg oral capsule once daily with morning meal for 6 weeks
placebo: Placebo Comparator	Other: placebo matched placebo orally for 6 weeks

Eligibility

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

Criteria

Inclusion Criteria:

Aged >= 40 years old
Diagnosed with OA of the knee according to the American College of Rheumatology and OA in flare state at baseline visit
Functional capacity class of I-III

Exclusion Criteria:

Inflammatory arthritis or gout or pseudo-gout with acute flare within the past 2 years (subjects with fibrositis or fibromyalgia will not be excluded)
Acute joint trauma at index joint within the past 3 months with active symptoms
Score of >=20 on PHQ-9 or score of >=1 on PHQ-9 item i
Use of mobility assisting device for <6 weeks or use of walker

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00620867

Show 33 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, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A3191063
Study First Received:	February 12, 2008
Last Updated:	November 5, 2008
ClinicalTrials.gov Identifier:	NCT00620867 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Anti-Inflammatory Agents
Ibuprofen
Celecoxib
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
Ibuprofen
Celecoxib
Molecular Mechanisms of Pharmacological Action
Osteoarthritis
Joint Diseases
Cyclooxygenase Inhibitors
Physiological Effects of Drugs
Enzyme Inhibitors
Rheumatic Diseases
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 06, 2009