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

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: Placebo Drug: Celecoxib	Phase IV

MedlinePlus related topics:

Osteoarthritis

Drug Information available for:

Ibuprofen Dexibuprofen Celecoxib 4-(5-(4-Methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl)benzenesulfonamide

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 [ Time Frame: Week 6 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change from baseline in American Pain Society Modified Brief Pain Inventory Short Form pain scores [ Time Frame: Days 1-7 ] [ Designated as safety issue: No ]
Change from baseline in patient's assessment of arthritis pain according to visual analogue scale [ Time Frame: Week 2 ] [ Designated as safety issue: No ]
Change from baseline in patient and physician global assessments of arthritis [ Time Frame: Weeks 2 and 6 ] [ 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 ]
The Pain Satisfaction Scale [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
The Patient Health Questionnaire (PHQ-9) [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
Measurement of upper gastrointestinal tolerability [ Time Frame: Weeks 2 and 6 ] [ Designated as safety issue: Yes ]
Adverse events [ Time Frame: Weeks 2 and 6 ] [ Designated as safety issue: Yes ]
Laboratory test results [ Time Frame: Week 6 ] [ Designated as safety issue: Yes ]
Vital signs [ Time Frame: Weeks 2 and 6 ] [ Designated as safety issue: Yes ]
Physical examination [ Time Frame: Week 6 ] [ Designated as safety issue: Yes ]

Enrollment:	388
Study Start Date:	January 2003
Study Completion Date:	February 2004

Arms	Assigned Interventions
A: Active Comparator	Drug: Ibuprofen 800 mg oral tablet 3 times daily with meals for 6 weeks
C: Placebo Comparator	Drug: Placebo Matched placebo orally for 6 weeks
B: Experimental	Drug: Celecoxib 200 mg oral capsule once daily with morning meal for 6 weeks

Eligibility

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

Criteria

Inclusion 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:

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: NCT00630929

Locations


Germany
	Pfizer Investigational Site
	Berlin, Germany, 12687
	Pfizer Investigational Site
	Berlin, Germany, 10435
	Pfizer Investigational Site
	Stade, Germany, 21680
	Pfizer Investigational Site
	SCHWERIN, Germany, 19057
	Pfizer Investigational Site
	TOSTEDT, Germany, 21255
	Pfizer Investigational Site
	Ostseebad Damp, Germany, 24351
	Pfizer Investigational Site
	WEENER, Germany, 26826
	Pfizer Investigational Site
	Berlin, Germany, 10559
	Pfizer Investigational Site
	Bad Muender, Germany, 31848
	Pfizer Investigational Site
	Berlin, Germany, 13125
	Pfizer Investigational Site
	Beckum, Germany, 59269

Spain
	Pfizer Investigational Site
	CADIZ, Spain, 11009
	Pfizer Investigational Site
	VALENCIA, Spain, 46009
	Pfizer Investigational Site
	GUADALAJARA, Spain, 19002
	Pfizer Investigational Site
	BARCELONA, Spain, 08036
	Pfizer Investigational Site
	SEVILLA, Spain, 41014
	Pfizer Investigational Site
	MADRID, Spain, 28046
	Pfizer Investigational Site
	MADRID, Spain, 28040
	Pfizer Investigational Site
	Madrid, Spain, 28035
	Pfizer Investigational Site
	BARCELONA, Spain, 08029
	Pfizer Investigational Site
	OVIEDO, Spain, 33006

United Kingdom
	Pfizer Investigational Site
	London, United Kingdom, NW3 2PF
	Pfizer Investigational Site
	MANCHESTER, United Kingdom, M41 5SL
	Pfizer Investigational Site
	NEWCASTLE UPON TYNE, United Kingdom, NE7 7DN
	Pfizer Investigational Site
	HUDDERSFIELD, United Kingdom, HD3 3EA
	Pfizer Investigational Site
	London, United Kingdom, SE5 9RS
	Pfizer Investigational Site
	Wigan, United Kingdom, WN6 9EW

United Kingdom, BIRMINGHAM
	Pfizer Investigational Site
	CHELMSLY WOOD, BIRMINGHAM, United Kingdom, B37 7TR

United Kingdom, Cornwall
	Pfizer Investigational Site
	Truro, Cornwall, United Kingdom, TR1 3LJ

United Kingdom, LANCS
	Pfizer Investigational Site
	CHORLEY, LANCS, United Kingdom, PR7 1NY
	Pfizer Investigational Site
	LIVERPOOL, LANCS, United Kingdom, L1 9AD

United Kingdom, Mid Staffordshire
	Pfizer Investigational Site
	Cannock, Mid Staffordshire, United Kingdom, WS11 2XY

United Kingdom, SURREY
	Pfizer Investigational Site
	ADDLESTONE, SURREY, United Kingdom, KT15 2BH

Sponsors and Collaborators

Pfizer

Investigators


Study Director:	Pfizer CT.gov Call Center	Pfizer

More Information

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

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A3191062
First Received:	February 28, 2008
Last Updated:	September 10, 2008
ClinicalTrials.gov Identifier:	NCT00630929
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Osteoarthritis, Knee

Ibuprofen

Celecoxib

Musculoskeletal Diseases

Osteoarthritis

Joint Diseases

Arthritis

Rheumatic Diseases

Additional relevant MeSH terms:

Anti-Inflammatory Agents

Molecular Mechanisms of Pharmacological Action

Physiological Effects of Drugs

Cyclooxygenase Inhibitors

Enzyme Inhibitors

Pharmacologic Actions

Analgesics, Non-Narcotic

Sensory System Agents

Therapeutic Uses

Anti-Inflammatory Agents, Non-Steroidal

Analgesics

Peripheral Nervous System Agents

Antirheumatic Agents

Central Nervous System Agents

ClinicalTrials.gov processed this record on October 31, 2008

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00630929