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Efficacy and Safety of Celecoxib Versus Ibuprofen in the Treatment of Osteoarthritis of the Knee (United States)

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00620867
First received: February 12, 2008
Last updated: November 5, 2008
Last verified: November 2008
  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: celecoxib
Other: placebo
Phase 4

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 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

Resource links provided by NLM:


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

Secondary Outcome Measures:
  • Vital signs [ Time Frame: Weeks 2 and 6 ] [ Designated as safety issue: Yes ]
  • Physical examination [ Time Frame: Week 6 ] [ Designated as safety issue: Yes ]
  • Laboratory test results [ Time Frame: Week 6 ] [ Designated as safety issue: Yes ]
  • Adverse events [ Time Frame: Weeks 2 and 6 ] [ Designated as safety issue: Yes ]
  • Change from baseline in patient's and physician's global assessment of pain [ Time Frame: Weeks 2 and 6 ] [ Designated as safety issue: No ]
  • Pain Satisfaction Scale [ Time Frame: Days 1-7 ] [ 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 ]
  • Patient Health Questionnaire (PHQ-9) [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
  • Change from baseline in patient's assessment of arthritis pain according to VAS [ Time Frame: Week 2 ] [ Designated as safety issue: No ]

Enrollment: 393
Study Start Date: October 2002
Study Completion Date: March 2003
Primary Completion Date: March 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ibuprofen Drug: Ibuprofen
800 mg oral tablet three time daily with meals for 6 weeks
Experimental: Celecoxib Drug: celecoxib
200 mg oral capsule once daily with morning meal for 6 weeks
Placebo Comparator: placebo Other: placebo
matched placebo orally for 6 weeks

  Eligibility

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

  • 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00620867

  Hide Study Locations
Locations
United States, Alabama
Pfizer Investigational Site
Anniston, Alabama, United States, 36207
United States, Arizona
Pfizer Investigational Site
Phoenix, Arizona, United States, 85051
United States, California
Pfizer Investigational Site
Anaheim, California, United States, 92804
Pfizer Investigational Site
Long Beach, California, United States, 90806
Pfizer Investigational Site
Paramount, California, United States, 90723
Pfizer Investigational Site
San Diego, California, United States, 92108
United States, Florida
Pfizer Investigational Site
Deland, Florida, United States, 32720
Pfizer Investigational Site
Miami, Florida, United States, 33186
Pfizer Investigational Site
Naples, Florida, United States, 34102
Pfizer Investigational Site
Pembroke Pines, Florida, United States, 33024
Pfizer Investigational Site
St Petersburg, Florida, United States, 33710
United States, Illinois
Pfizer Investigational Site
Chicago, Illinois, United States, 60610
United States, Indiana
Pfizer Investigational Site
Evansville, Indiana, United States, 47712
United States, Nevada
Pfizer Investigational Site
Las Vegas, Nevada, United States, 89102
United States, New Jersey
Pfizer Investigational Site
Edison, New Jersey, United States, 08817
Pfizer Investigational Site
South Plainfield, New Jersey, United States, 07080
United States, New Mexico
Pfizer Investigational Site
Albuquerque, New Mexico, United States, 87109
United States, New York
Pfizer Investigational Site
Brooklyn, New York, United States, 11203
Pfizer Investigational Site
New York, New York, United States, 10022-1009
United States, Ohio
Pfizer Investigational Site
Cincinnati, Ohio, United States, 45242
Pfizer Investigational Site
Columbus, Ohio, United States, 43124
United States, Oklahoma
Pfizer Investigational Site
Tulsa, Oklahoma, United States, 74136
United States, Pennsylvania
Pfizer Investigational Site
Altoona, Pennsylvania, United States, 16601
Pfizer Investigational Site
Jenkintown, Pennsylvania, United States, 19046
Pfizer Investigational Site
Newtown, Pennsylvania, United States, 18940
United States, Rhode Island
Pfizer Investigational Site
Warwick, Rhode Island, United States, 02886
United States, South Carolina
Pfizer Investigational Site
Charleston, South Carolina, United States, 29407
Pfizer Investigational Site
Greer, South Carolina, United States, 29651
Pfizer Investigational Site
Mount Pleasant, South Carolina, United States, 29464
United States, Tennessee
Pfizer Investigational Site
Johnson City, Tennessee, United States, 37601
United States, Texas
Pfizer Investigational Site
Dallas, Texas, United States, 75235
United States, Utah
Pfizer Investigational Site
Layton, Utah, United States, 84041
United States, Virginia
Pfizer Investigational Site
Danville, Virginia, United States, 24541
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00620867     History of Changes
Other Study ID Numbers: A3191063
Study First Received: February 12, 2008
Last Updated: November 5, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Celecoxib
Ibuprofen
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014