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

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: NCT00640627
Recruitment Status : Completed
First Posted : March 21, 2008
Last Update Posted : April 7, 2008
Information provided by:

Brief Summary:
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 or disease Intervention/treatment Phase
Osteoarthritis, Knee Drug: Celecoxib Drug: Placebo Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 380 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : December 2003
Actual Study Completion Date : September 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: A Drug: Celecoxib
200 mg oral capsule once daily for 6 weeks

Placebo Comparator: B Drug: Placebo
Matched oral placebo for 6 weeks

Primary Outcome Measures :
  1. Change from baseline in Patient's Assessment of Arthritis Pain, according to visual analog scale (VAS) [ Time Frame: Week 6 ]

Secondary Outcome Measures :
  1. Western Ontario and McMaster Universities Osteoarthritis Index [ Time Frame: Week 6 ]
  2. Patient's and Physician's Global Assessment of Pain [ Time Frame: Weeks 2 and 6 ]
  3. The Medical Outcomes Study Sleep Scale [ Time Frame: Week 6 ]
  4. Adverse events [ Time Frame: Weeks 0-6 ]
  5. Laboratory tests [ Time Frame: Week 6 ]
  6. Vital signs [ Time Frame: Week 6 ]
  7. Physical examination [ Time Frame: Week 6 ]
  8. Patient's Assessment of Arthritis Pain according to VAS [ Time Frame: Week 2 ]
  9. Serious adverse events [ Time Frame: Up to 30 days after last dose ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

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

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): NCT00640627

  Show 30 Study Locations
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc Identifier: NCT00640627     History of Changes
Other Study ID Numbers: A3191069
First Posted: March 21, 2008    Key Record Dates
Last Update Posted: April 7, 2008
Last Verified: March 2008

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