Rheumatoid Arthritis Dose Ranging Study (0663-086)(COMPLETED)
NCT ID: NCT00264147
Last Updated: 2022-02-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
761 participants
INTERVENTIONAL
2006-01-31
2008-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Period I: 1
etoricoxib
etoricoxib
Period I: Arm 1: etoricoxib 10 mg tablet once daily. 12 weeks of treatment.
Period I: 2
etoricoxib
etoricoxib
Period I: Arm 2: etoricoxib 30 mg tablet once daily. 12 weeks of treatment.
Period I: 3
etoricoxib
etoricoxib
Period I: Arm 3: etoricoxib 60 mg tablet once daily. 12 weeks of treatment.
Period I: 4
etoricoxib
etoricoxib
Period I: Arm 4: etoricoxib 90 mg tablet once daily. 12 weeks of treatment.
Period I: 5
Placebo
Comparator: placebo
Period I: Arm 5: Pbo tablet once daily. 12 weeks of treatment.
Period II: 1
etoricoxib
etoricoxib
Period II: Arm 1: etoricoxib 90 mg tablet once daily. 12 weeks of treatment.
Period II: 2
diclofenac
Comparator: diclofenac
Period II: Arm 2: diclofenac 75 mg tablet twice daily. 12 weeks of treatment.
Interventions
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etoricoxib
Period I: Arm 1: etoricoxib 10 mg tablet once daily. 12 weeks of treatment.
etoricoxib
Period I: Arm 2: etoricoxib 30 mg tablet once daily. 12 weeks of treatment.
etoricoxib
Period I: Arm 3: etoricoxib 60 mg tablet once daily. 12 weeks of treatment.
etoricoxib
Period I: Arm 4: etoricoxib 90 mg tablet once daily. 12 weeks of treatment.
Comparator: placebo
Period I: Arm 5: Pbo tablet once daily. 12 weeks of treatment.
etoricoxib
Period II: Arm 1: etoricoxib 90 mg tablet once daily. 12 weeks of treatment.
Comparator: diclofenac
Period II: Arm 2: diclofenac 75 mg tablet twice daily. 12 weeks of treatment.
Eligibility Criteria
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Inclusion Criteria
* Patient will need to stop taking these medications in order to participate, but can continue taking his/her other anti-rheumatic medications as long as they have been stable for certain periods of time
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Organon and Co
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Monitor
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
References
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Greenwald M, Peloso PM, Mandel D, Soto O, Mehta A, Frontera N, Boice JA, Zhan XJ, Curtis SP. Further assessment of the clinically effective dose range of etoricoxib: a randomized, double-blinded, placebo-controlled trial in rheumatoid arthritis. Curr Med Res Opin. 2011 Oct;27(10):2033-42. doi: 10.1185/03007995.2011.614935. Epub 2011 Sep 12.
Kvien TK, Greenwald M, Peloso PM, Wang H, Mehta A, Gammaitoni A. Do COX-2 inhibitors provide additional pain relief and anti-inflammatory effects in patients with rheumatoid arthritis who are on biological disease-modifying anti-rheumatic drugs and/or corticosteroids? Post-hoc analyses from a randomized clinical trial with etoricoxib. BMC Musculoskelet Disord. 2015 Feb 13;16:26. doi: 10.1186/s12891-015-0468-7.
Other Identifiers
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2005_077
Identifier Type: -
Identifier Source: secondary_id
0663-086
Identifier Type: -
Identifier Source: org_study_id
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