Efficacy and Safety of Celecoxib Versus Placebo in the Treatment of Patients With Osteoarthritis of the Knee Who Were Unresponsive to Naproxen and Ibuprofen - Full Text View

Purpose

To compare the safety and efficacy of celecoxib versus placebo in the treatment of patients with knee osteoarthritis who were unresponsive to treatment with prescription strength naproxen and ibuprofen or who could not tolerate prescription strength naproxen and ibuprofen

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

MedlinePlus related topics:

Osteoarthritis

ChemIDplus related topics:

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

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study

Official Title:	A Double-Blind, Placebo-Controlled Study of the Efficacy and Tolerability of Once Daily Celebrex® (Celecoxib) vs. Placebo in the Treatment of Subjects With Osteoarthritis of the Knee Non-Responsive to Naproxen and Ibuprofen

Further study details as provided by Pfizer:

Primary Outcome Measures:

Change from baseline in Patient's Assessment of Arthritis Pain, according to visual analog scale (VAS) [ Time Frame: Week 6 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Western Ontario and McMaster Universities Osteoarthritis Index [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
Patient's and Physician's Global Assessment of Pain [ Time Frame: Weeks 2 and 6 ] [ Designated as safety issue: No ]
The Medical Outcomes Study Sleep Scale [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
Adverse events [ Time Frame: Weeks 0-6 ] [ Designated as safety issue: Yes ]
Laboratory tests [ Time Frame: Week 6 ] [ Designated as safety issue: Yes ]
Vital signs [ Time Frame: Week 6 ] [ Designated as safety issue: Yes ]
Physical examination [ Time Frame: Week 6 ] [ Designated as safety issue: Yes ]
Patient's Assessment of Arthritis Pain according to VAS [ Time Frame: Week 2 ] [ Designated as safety issue: No ]
Serious adverse events [ Time Frame: Up to 30 days after last dose ] [ Designated as safety issue: Yes ]

Enrollment:	380
Study Start Date:	December 2003
Study Completion Date:	September 2004

Arms	Assigned Interventions
A: Experimental	Drug: Celecoxib 200 mg oral capsule once daily for 6 weeks
B: Placebo Comparator	Drug: Placebo Matched oral placebo for 6 weeks

Eligibility

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

Criteria

Inclusion criteria:

OA of the knee in flare state at baseline visit and functional capacity class of I-III
Failed adequate trials of both naproxen and ibuprofen (prescription strength) within the past 5 years due to lack of efficacy, tolerability or both; duration of prescription strength ibuprofen and naproxen must have been a minimum of 2 weeks for each drug at the respective recommended doses if failure was due to lack of efficacy, and for any duration if failure was due to lack of tolerability

Exclusion criteria:

Inflammatory arthritis or gout/pseudo-gout with acute flare within the past 2 years (subjects with fibrositis or fibromyalgia will not be excluded)
Received acetaminophen within 24 hours of baseline visit
Use of mobility assisting device for less than six weeks prior to study screening or use of a walker
History of gastrointestinal (GI) perforation, obstruction, or bleeding
Diagnosed or treated for GI ulcer within 60 days prior to first dose of study medication
Recieved corticosteroids or hyaluronic acid within certain timeframe before study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00640627

Show 30 Study Locations

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

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

Responsible Party:	Pfizer, Inc ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A3191069
First Received:	March 17, 2008
Last Updated:	April 2, 2008
ClinicalTrials.gov Identifier:	NCT00640627
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Osteoarthritis, Knee

Ibuprofen

Naproxen

Celecoxib

Musculoskeletal Diseases

Osteoarthritis

Joint Diseases

Arthritis

Rheumatic Diseases

Additional relevant MeSH terms:

Anti-Inflammatory Agents

Molecular Mechanisms of Pharmacological Action

Cyclooxygenase Inhibitors

Physiological Effects of Drugs

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 17, 2008

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00640627