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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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21 February 2022 |
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Main ID: |
NCT00092742 |
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Date of registration:
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23/09/2004 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Investigational Drug Versus an Approved Drug in Patients With Rheumatoid Arthritis (0663-072)
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Scientific title:
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A Randomized, Double-Blind, Multicenter Study to Evaluate the Tolerability and Effectiveness of Etoricoxib 90 mg q.d. vs. Diclofenac Sodium 75 mg b.i.d. in Patients With Rheumatoid Arthritis |
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Date of first enrolment:
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February 2003 |
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Target sample size:
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4086 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00092742 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
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Phase:
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Phase 3
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Countries of recruitment
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United States
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Contacts
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Name:
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Medical Monitor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Merck Sharp & Dohme Corp. |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Males and females 50 years or older with rheumatoid arthritis.
Exclusion Criteria:
- History of gastrointestinal malabsorption or inflammatory bowel disease
- History of heart problems such as: congestive heart failure (CHF), heart attack or
high blood pressure.
Age minimum:
50 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Rheumatoid Arthritis
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Intervention(s)
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Drug: MK0663, etoricoxib
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Drug: Comparator: Diclofenac sodium
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Primary Outcome(s)
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Discontinuations due to clinical and laboratory gastrointestinal adverse experiences
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Secondary ID(s)
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2004_055
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0663-072
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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