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Meloxicam [Mobic] in Juvenile Rheumatoid Arthritis (JRA)
This study has been completed.
First Received: May 2, 2002   Last Updated: September 22, 2009   History of Changes
Sponsor: Boehringer Ingelheim Pharmaceuticals
Information provided by: Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00034853
  Purpose

Safety and efficacy of meloxicam oral suspension in juvenile rheumatoid arthritis


Condition Intervention Phase
Arthritis, Juvenile Rheumatoid
Drug: meloxicam oral suspension
Drug: naproxen oral suspension
Phase III

Study Type: Interventional
Study Design: Treatment, Parallel Assignment, Safety/Efficacy Study
Official Title: Safety and Efficacy of Meloxicam Oral Suspension in JRA (Subtrial of 107.208)

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:
  • Responder rate by core set of outcome criteria (Juvenile Rheumatoid Arthritis Pediatric 30): global assessment disease activity; functional disability, number joints arthritis, limited motion; erythrocyte sedimentation rate; [ Time Frame: week 12 ]

Secondary Outcome Measures:
  • Individual core set outcome criteria; final global assessment of efficacy; tolerability; AE incidence and intensity; withdrawals; acetaminophen consumption; safety labs: physical examination; hospitalization for gastrointestinal (GI) SAE, GI AE [ Time Frame: weeks 4, 8, 12, 18, and 24 ]

Estimated Enrollment: 180
Study Start Date: November 2000
Primary Completion Date: June 2003 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   2 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • diagnosis of juvenile idiopathic arthritis (JIA) by International League of Associations for Rheumatology (ILAR) criteria; pauciarthritic, extended pauciarthritic, or polyarthritic current course of disease;
  • 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

Exclusion Criteria:

  • systemic course of juvenile idiopathic arthritis
  • all rheumatic conditions not included in inclusion criteria; any clinical finding or abnormal clinically relevant lab (not due to JIA) that could interfere with conduct of clinical trial
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00034853

  Hide Study Locations
Locations
United States, Arkansas
107.235.23 Arkansas Children's Hospital
Little Rock, Arkansas, United States
United States, California
107.235.17 Valley Children's Hospital
Madera, California, United States
107.235.37
San Diego, California, United States
United States, Colorado
107.235.4 Boehringer Ingelheim Investigational Site
Denver, Colorado, United States
United States, Connecticut
107.235.12 Boehringer Ingelheim Investigational Site
Hartford, Connecticut, United States
United States, Delaware
107.235.13 Alfred I. DuPont Hospital for Children
Wilmington, Delaware, United States
United States, Florida
107.235.36 Arthritis Associates Clinical Research of South Florida
Del Ray Beach, Florida, United States
107.235.21 Miami Children's Hospital
Miami, Florida, United States
107.235.38 Clinical Research Dept #7006
St. Petersberg, Florida, United States
United States, Illinois
107.235.8 Boehringer Ingelheim Investigational Site
Chicago, Illinois, United States
United States, Kansas
107.235.7 Boehringer Ingelheim Investigational Site
Kansas City, Kansas, United States
United States, Kentucky
107.235.25 University of Louisville
Louisville, Kentucky, United States
United States, Louisiana
107.235.16 Children's Hospital - Department of Rheumatology
New Orleans, Louisiana, United States
United States, Massachusetts
107.235.26 Deparment of Rheumatology
Boston, Massachusetts, United States
United States, Minnesota
107.235.2 E15 Mayo Clinic
Rochester, Minnesota, United States
United States, Missouri
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
United States, Nebraska
107.235.31 Department of Pediatrics
Omaha, Nebraska, United States
United States, New Jersey
107.235.35 Arthritis and Rheumatic Disease Center
Livingston, New Jersey, United States
United States, New York
107.235.19 Columbia Presbyterian Medical Center
New York, New York, United States
107.235.24 The Children's Hospital of Buffalo
Buffalo, New York, United States
United States, Oklahoma
107.235.33 Healthcare Research Consultants
Tulsa, Oklahoma, United States
107.235.22 Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma, United States
United States, Pennsylvania
107.235.32 Arthritis and Osteoporosis Center
Duncansville, Pennsylvania, United States
United States, Rhode Island
107.235.39 Division of Ambulatory Pediatrics
Providence, Rhode Island, United States
United States, Texas
107.235.10 Texas Scottish Rite Hospital
Dallas, Texas, United States
United States, Utah
107.235.1 University of Utah School of Medicine
Salt Lake CIty, Utah, United States
United States, Washington
107.235.30 Children's Hospital
Seattle, Washington, United States
United States, Wisconsin
107.235.20 Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Brazil
107.235.60
Sao Paulo, Brazil
107.235.61
Cerqueira César, Brazil
107.235.62
Santa Cecília, Brazil
Mexico
107.235.40
México, D.F., Mexico
Ukraine
107.235.73 2nd Children Specialized Clinical Hospital "OHMADIT"
Kiev, Ukraine
107.235.71 Institute of Children and Adolescents Health
Kharkov, Ukraine
107.235.72 Institute of Pediatrics
Kiev, Ukraine
107.235.70 Children Clinical Hospital No. 1
Kiev, Ukraine
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim Pharmaceuticals
  More Information

Additional Information:
No publications provided

Responsible Party: Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair )
Study ID Numbers: 107.235
Study First Received: May 2, 2002
Last Updated: September 22, 2009
ClinicalTrials.gov Identifier: NCT00034853     History of Changes
Health Authority: Argentina: Ministry of Health;   Brazil: Ministry of Health;   Mexico: Ministry of Health;   Ukraine: Ministry of Health;   United States: Food and Drug Administration

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Arthritis, Rheumatoid
Gout Suppressants
Musculoskeletal Diseases
Sensory System Agents
Arthritis
Therapeutic Uses
Connective Tissue Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Naproxen
Autoimmune Diseases
Arthritis, Juvenile Rheumatoid
Immune System Diseases
Joint Diseases
Meloxicam
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Rheumatic Diseases
Pharmacologic Actions
Analgesics, Non-Narcotic
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 27, 2009