Efficacy and Safety of Celecoxib Versus Ibuprofen in the Treatment of Osteoarthritis of the Knee (Europe)
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00630929
First received: February 28, 2008
Last updated: September 10, 2008
Last verified: September 2008
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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
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, 12687 | |
| Pfizer Investigational Site | |
| Berlin, Germany, 10435 | |
| Pfizer Investigational Site | |
| Berlin, Germany, 10559 | |
| Pfizer Investigational Site | |
| Berlin, Germany, 13125 | |
| 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 May 23, 2013