Safety and Efficacy Study of Tranilast in Patients With Active Rheumatoid Arthritis (RA)
NCT ID: NCT00882024
Last Updated: 2011-01-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
250 participants
INTERVENTIONAL
2009-03-31
2010-12-31
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
QUADRUPLE
Study Groups
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1 Tranilast
Tranilast, 300 mg/day
Tranilast
150 mg tranilast tablets, bid, 12 weeks
2 Tranilast
Tranilast, 150 mg/day
Tranilast
75 mg tablets, bid, 12 weeks
3
Placebo
Placebo
Placebo tablets, bid, 12 weeks
Interventions
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Tranilast
150 mg tranilast tablets, bid, 12 weeks
Tranilast
75 mg tablets, bid, 12 weeks
Placebo
Placebo tablets, bid, 12 weeks
Eligibility Criteria
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Inclusion Criteria
* Have at least 8 painful/tender and 6 swollen joints
* May be receiving oral steroids, chronic NSAIDs and/or hydroxychloroquine.
* Pregnant or nursing females
* Abnormal laboratory values
* History of clinically significant renal, hepatic dysfunction, psychiatric disorder, or alcohol/drug dependence
* Clinically significant systemic infection
18 Years
75 Years
ALL
No
Sponsors
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Nuon Therapeutics, Inc.
INDUSTRY
Responsible Party
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Nuon Therapeutics, Inc.
Principal Investigators
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Michael Kitt, MD
Role: STUDY_DIRECTOR
Nuon Therapeutics, Inc.
Locations
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Mesa, Arizona, United States
Paradise Valley, Arizona, United States
La Jolla, California, United States
San Diego, California, United States
Aventura, Florida, United States
Frederick, Maryland, United States
Lansing, Michigan, United States
Hickory, North Carolina, United States
Duncansville, Pennsylvania, United States
Capital Federal, Buenos Aires, Argentina
Luján, Buenos Aires, Argentina
Quilmes, Buenos Aires, Argentina
Rosario, Santa Fe Province, Argentina
Plovdiv, , Bulgaria
Sofia, , Bulgaria
Brno-Bohunice, , Czechia
Ostrava-Hlucin, , Czechia
Prague, , Czechia
Zlín, , Czechia
Hamburg, , Germany
Ludwigsfelde, , Germany
Naumburg, , Germany
Osnabrück, , Germany
Ratingen, , Germany
Wiesbaden, , Germany
Mexicali, Estado de Baja California, Mexico
Guadalajara, Jalisco, Mexico
Morelia, Michoacán, Mexico
Obregón, Sonora, Mexico
Belgrade, , Serbia
Niška Banja, , Serbia
London, , United Kingdom
Countries
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Other Identifiers
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A3003RA
Identifier Type: -
Identifier Source: org_study_id
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