Efficacy and Safety of Celecoxib Versus Ibuprofen in the Treatment of Osteoarthritis of the Knee (Europe)
NCT00630929
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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
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Descriptive Information | ||||
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Brief Title ICMJE | Efficacy and Safety of Celecoxib Versus Ibuprofen in the Treatment of Osteoarthritis of the Knee (Europe) | |||
Official Title ICMJE | 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 | |||
Brief Summary | To compare the efficacy and safety of celecoxib versus ibuprofen in subjects with osteoarthritis (OA) of the knee. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 4 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment | |||
Condition ICMJE | Osteoarthritis, Knee | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Gordo AC, Walker C, Armada B, Zhou D. Efficacy of celecoxib versus ibuprofen for the treatment of patients with osteoarthritis of the knee: A randomized double-blind, non-inferiority trial. J Int Med Res. 2017 Feb;45(1):59-74. doi: 10.1177/0300060516673707. Epub 2017 Jan 12. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 388 | |||
Original Actual Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | February 2004 | |||
Primary Completion Date | Not Provided | |||
Eligibility Criteria ICMJE | Inclusion Criteria: Inclusion criteria:
Exclusion Criteria: Exclusion criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 40 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Germany, Spain, United Kingdom | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00630929 | |||
Other Study ID Numbers ICMJE | A3191062 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Director, Clinical Trial Disclosure Group, Pfizer, Inc. | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
| |||
PRS Account | Pfizer | |||
Verification Date | September 2008 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |