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

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00638807

Purpose

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

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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Osteoarthritis

Drug Information available for: Ibuprofen Naproxen Naproxen sodium Celecoxib

U.S. FDA Resources

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:

Patient's Assessment of Arthritis Pain, according to VAS [ Time Frame: Week 2 ] [ Designated as safety issue: No ]
The Western Ontario and McMaster Universities Osteoarthritis Index [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
Patient's and Physician's Global Assessment of Arthritis [ 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 ]
Serious adverse events [ Time Frame: Up to 30 days after last dose ] [ Designated as safety issue: Yes ]

Enrollment:	388
Study Start Date:	December 2003
Study Completion Date:	July 2004

Arms	Assigned Interventions
Experimental: A	Drug: Celecoxib 200 mg oral capsule once daily with morning meal for 6 weeks
Placebo Comparator: B	Other: 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:

Inclusion criteria:

Diagnosed, active, and symptomatic OA of the knee in a flare state with a functional capacity class of I-III at baseline visit
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:

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 the baseline visit
Use of a 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
Received corticosteroids or hyaluronic acid within certain timeframe before study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00638807

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

No publications provided

Responsible Party:	Director, Clinical Trial Disclosure Group, Pfizer, Inc
ClinicalTrials.gov Identifier:	NCT00638807 History of Changes
Other Study ID Numbers:	A3191082
Study First Received:	March 12, 2008
Last Updated:	March 12, 2009
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Naproxen
Ibuprofen
Celecoxib
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents

Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents
Cyclooxygenase 2 Inhibitors

ClinicalTrials.gov processed this record on February 09, 2012