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

  Show 33 Study Locations
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
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
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents
Cyclooxygenase 2 Inhibitors

ClinicalTrials.gov processed this record on September 18, 2014