Meloxicam [Mobic] in Juvenile Rheumatoid Arthritis (JRA)
NCT ID: NCT00034853
Last Updated: 2013-11-01
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
PHASE3
180 participants
INTERVENTIONAL
2000-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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PARALLEL
TREATMENT
Interventions
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meloxicam oral suspension
naproxen oral suspension
Eligibility Criteria
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Inclusion Criteria
* active arthritis of at least 2 joints
* at least 2 other abnormal variables of the 5 remaining core set parameters
* require nonsteroidal anti-inflammatory drugs (NSAIDs)
* children aged 2-17 years
* weight of 9 kg or less
* pregnancy or breast feeding
* females of childbearing potential who are sexually active and not using adequate contraception for at least 3 mos prior to and for duration of study
* history of bleeding disorder, gastrointestinal bleeding, or cerebrovascular bleeding
* peptic ulcer past 6 months
* more than 1 disease modifying anti-rheumatic drug (DMARD) or change in DMARD during 3 months prior
* change corticosteroids during 1 month prior
* systemic corticosteroids greater than 10 mg/d, hydroxychloroquine greater than 10/mg/d, cyclosporine greater than 5 mg/kg/d., methotrexate greater than 15 mg/m2/wk, cytotoxic agents, gold, D-penicilamine, sulfasalazine, glucosamine, and investigational products
* etanercept during 1 month prior; infliximab during 2 months prior; intra-articular corticosteroids during 1 month prior
* patients requiring concomitant other NSAID including topical (excluding ophthalmic)
* requirement for use of other NSAIDs, anticoagulants, phenothiazine, lithium, or ACTH
* insufficient effect or intolerability to naproxen or meloxicam
* known or suspected hypersensitivity to trial meds or their excipients
* requirement of chronic H2 antagonist
* history of asthma, nasal polyps, angioneurotic edema, or urticaria with aspirin or NSAIDs
* planned surgical procedures during study
* investigational drug exposure during this trial or within 30 days (or 6 half lives, whichever greater) prior
* previous participation in this trial
* patients with known drug or alcohol abuse
* patient, parent or legal representative unable to understand and to comply with protocol
Exclusion Criteria
2 Years
17 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Boehringer Ingelheim
Principal Investigators
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Boehringer Ingelheim
Role: STUDY_CHAIR
Boehringer Ingelheim
Locations
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107.235.23 Arkansas Children's Hospital
Little Rock, Arkansas, United States
107.235.17 Valley Children's Hospital
Madera, California, United States
107.235.37
San Diego, California, United States
107.235.4 Boehringer Ingelheim Investigational Site
Denver, Colorado, United States
107.235.12 Boehringer Ingelheim Investigational Site
Hartford, Connecticut, United States
107.235.13 Alfred I. DuPont Hospital for Children
Wilmington, Delaware, United States
107.235.36 Arthritis Associates Clinical Research of South Florida
Delray Beach, Florida, United States
107.235.21 Miami Children's Hospital
Miami, Florida, United States
107.235.38 Clinical Research Dept #7006
Saint Petersberg, Florida, United States
107.235.8 Boehringer Ingelheim Investigational Site
Chicago, Illinois, United States
107.235.7 Boehringer Ingelheim Investigational Site
Kansas City, Kansas, United States
107.235.25 University of Louisville
Louisville, Kentucky, United States
107.235.16 Children's Hospital - Department of Rheumatology
New Orleans, Louisiana, United States
107.235.26 Deparment of Rheumatology
Boston, Massachusetts, United States
107.235.2 E15 Mayo Clinic
Rochester, Minnesota, United States
107.235.18 Washington University School of Medicine
St Louis, Missouri, United States
107.235.9 Boehringer Ingelheim Investigational Site
St Louis, Missouri, United States
107.235.31 Department of Pediatrics
Omaha, Nebraska, United States
107.235.35 Arthritis and Rheumatic Disease Center
Livingston, New Jersey, United States
107.235.24 The Children's Hospital of Buffalo
Buffalo, New York, United States
107.235.19 Columbia Presbyterian Medical Center
New York, New York, United States
107.235.22 Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma, United States
107.235.33 Healthcare Research Consultants
Tulsa, Oklahoma, United States
107.235.32 Arthritis and Osteoporosis Center
Duncansville, Pennsylvania, United States
107.235.39 Division of Ambulatory Pediatrics
Providence, Rhode Island, United States
107.235.10 Texas Scottish Rite Hospital
Dallas, Texas, United States
107.235.1 University of Utah School of Medicine
Salt Lake City, Utah, United States
107.235.30 Children's Hospital
Seattle, Washington, United States
107.235.20 Medical College of Wisconsin
Milwaukee, Wisconsin, United States
107.235.61
Cerqueira César, , Brazil
107.235.62
Santa Cecília, , Brazil
107.235.60
São Paulo, , Brazil
107.235.40
México, D.F., , Mexico
107.235.71 Institute of Children and Adolescents Health
Kharkiv, , Ukraine
107.235.70 Children Clinical Hospital No. 1
Kiev, , Ukraine
107.235.72 Institute of Pediatrics
Kiev, , Ukraine
107.235.73 2nd Children Specialized Clinical Hospital "OHMADIT"
Kiev, , Ukraine
Countries
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Other Identifiers
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107.235
Identifier Type: -
Identifier Source: org_study_id
NCT00274482
Identifier Type: -
Identifier Source: nct_alias