Safety and Efficacy of Celecoxib Versus Naproxen in the 6-Month Treatment of Knee Osteoarthritis (CLOAK)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00643799
Recruitment Status : Completed
First Posted : March 26, 2008
Last Update Posted : April 24, 2008
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Brief Summary:
To compare the safety and efficacy of celecoxib versus naproxen for the treatment of knee osteoarthritis

Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Drug: Celecoxib Drug: Naproxen Drug: Placebo Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 586 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Study Start Date : March 2004
Primary Completion Date : January 2005
Study Completion Date : January 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources

Arm Intervention/treatment
Experimental: A Drug: Celecoxib
200 mg oral capsule once daily for 6 months
Active Comparator: B Drug: Naproxen
500 mg oral capsule twice daily for 6 months
Placebo Comparator: C Drug: Placebo
Matched oral placebo for 6 months

Primary Outcome Measures :
  1. Number of responders, defined as a 20% improvement from baseline in the The Western Ontario MacMaster (WOMAC)Questionnaire Total Score [ Time Frame: Month 6 ]

Secondary Outcome Measures :
  1. Number of health care professional contacts [ Time Frame: Throughout study ]
  2. Patient's and Physician's Satisfaction with Current Arthritis Therapy [ Time Frame: Month 6 ]
  3. Change in WOMAC Total Score from baseline [ Time Frame: Month 6 ]
  4. Change in WOMAC Subscales from baseline [ Time Frame: Month 6 ]
  5. Response in each WOMAC Subscale [ Time Frame: Month 6 ]
  6. Change in Medical Outcome Study sleep scale from baseline [ Time Frame: Month 6 ]
  7. Laboratory tests [ Time Frame: Month 6 ]
  8. Vital signs [ Time Frame: Month 6 ]
  9. Response in VAS [ Time Frame: Month 6 ]
  10. Change in Patient's and Physician's Global Assessment of Pain from baseline [ Time Frame: Month 6 ]
  11. Change in visual analog scale (VAS) from baseline [ Time Frame: Month 6 ]
  12. Adverse events [ Time Frame: Throughout study ]
  13. Change in Gastrointestinal (GI) Distress Scale from Week 1 [ Time Frame: Month 6 ]
  14. Change in GI Distress Scale from time of discontinuation of study drug [ Time Frame: Month 6 ]
  15. Receipt of prescription or over-the-counter gastroprotective agents or pain medications (off study drug) [ Time Frame: Throughout study ]
  16. Number of hospitalizations, emergency room visits, and procedures [ Time Frame: Throughout study ]
  17. Change in Work Limitation Questionnaire scale scores from baseline [ Time Frame: Month 6 ]
  18. Physical examination [ Time Frame: Month 6 ]

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00643799

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Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc Identifier: NCT00643799     History of Changes
Other Study ID Numbers: A3191152
First Posted: March 26, 2008    Key Record Dates
Last Update Posted: April 24, 2008
Last Verified: April 2008

Additional relevant MeSH terms:
Osteoarthritis, Knee
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gout Suppressants