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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00630929
First received: February 28, 2008
Last updated: September 10, 2008
Last verified: September 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: Placebo
Drug: Celecoxib
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 [ Time Frame: Week 6 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in American Pain Society Modified Brief Pain Inventory Short Form pain scores [ Time Frame: Days 1-7 ] [ Designated as safety issue: No ]
  • Change from baseline in patient's assessment of arthritis pain according to visual analogue scale [ Time Frame: Week 2 ] [ Designated as safety issue: No ]
  • Change from baseline in patient and physician global assessments of arthritis [ Time Frame: Weeks 2 and 6 ] [ 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 ]
  • The Pain Satisfaction Scale [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
  • The Patient Health Questionnaire (PHQ-9) [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
  • Measurement of upper gastrointestinal tolerability [ Time Frame: Weeks 2 and 6 ] [ Designated as safety issue: Yes ]
  • Adverse events [ Time Frame: Weeks 2 and 6 ] [ Designated as safety issue: Yes ]
  • Laboratory test results [ Time Frame: Week 6 ] [ Designated as safety issue: Yes ]
  • Vital signs [ Time Frame: Weeks 2 and 6 ] [ Designated as safety issue: Yes ]
  • Physical examination [ Time Frame: Week 6 ] [ Designated as safety issue: Yes ]

Enrollment: 388
Study Start Date: January 2003
Study Completion Date: February 2004
Arms Assigned Interventions
Active Comparator: A Drug: Ibuprofen
800 mg oral tablet 3 times daily with meals for 6 weeks
Placebo Comparator: C Drug: Placebo
Matched placebo orally for 6 weeks
Experimental: B Drug: Celecoxib
200 mg oral capsule once daily with morning meal 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:

  • 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:

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: NCT00630929

Locations
Germany
Pfizer Investigational Site
Bad Muender, Germany, 31848
Pfizer Investigational Site
Beckum, Germany, 59269
Pfizer Investigational Site
Berlin, Germany, 10435
Pfizer Investigational Site
Berlin, Germany, 10559
Pfizer Investigational Site
Berlin, Germany, 13125
Pfizer Investigational Site
Berlin, Germany, 12687
Pfizer Investigational Site
Ostseebad Damp, Germany, 24351
Pfizer Investigational Site
Schwerin, Germany, 19057
Pfizer Investigational Site
Stade, Germany, 21680
Pfizer Investigational Site
Tostedt, Germany, 21255
Pfizer Investigational Site
Weener, Germany, 26826
Spain
Pfizer Investigational Site
Barcelona, Spain, 08029
Pfizer Investigational Site
Barcelona, Spain, 08036
Pfizer Investigational Site
Cadiz, Spain, 11009
Pfizer Investigational Site
Guadalajara, Spain, 19002
Pfizer Investigational Site
Madrid, Spain, 28046
Pfizer Investigational Site
Madrid, Spain, 28035
Pfizer Investigational Site
Madrid, Spain, 28040
Pfizer Investigational Site
Oviedo, Spain, 33006
Pfizer Investigational Site
Sevilla, Spain, 41014
Pfizer Investigational Site
Valencia, Spain, 46009
United Kingdom
Pfizer Investigational Site
Chelmsly Wood, Birmingham, United Kingdom, B37 7TR
Pfizer Investigational Site
Truro, Cornwall, United Kingdom, TR1 3LJ
Pfizer Investigational Site
Chorley, Lancs, United Kingdom, PR7 1NY
Pfizer Investigational Site
Liverpool, Lancs, United Kingdom, L1 9AD
Pfizer Investigational Site
Cannock, Mid Staffordshire, United Kingdom, WS11 2XY
Pfizer Investigational Site
Addlestone, Surrey, United Kingdom, KT15 2BH
Pfizer Investigational Site
Huddersfield, United Kingdom, HD3 3EA
Pfizer Investigational Site
London, United Kingdom, SE5 9RS
Pfizer Investigational Site
London, United Kingdom, NW3 2PF
Pfizer Investigational Site
Manchester, United Kingdom, M41 5SL
Pfizer Investigational Site
Newcastle Upon Tyne, United Kingdom, NE7 7DN
Pfizer Investigational Site
Wigan, United Kingdom, WN6 9EW
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: NCT00630929     History of Changes
Other Study ID Numbers: A3191062
Study First Received: February 28, 2008
Last Updated: September 10, 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 October 19, 2014