| May 2, 2002 |
| September 22, 2009 |
| November 2000 |
| June 2003 (final data collection date for primary outcome measure) |
| 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 ] |
| Same as current |
| Complete list of historical versions of study NCT00034853 on ClinicalTrials.gov Archive Site |
| 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 ] |
| Same as current |
| |
| Meloxicam [Mobic] in Juvenile Rheumatoid Arthritis (JRA) |
| Safety and Efficacy of Meloxicam Oral Suspension in JRA (Subtrial of 107.208) |
Safety and efficacy of meloxicam oral suspension in juvenile rheumatoid arthritis |
| |
| Phase III |
| Interventional |
| Treatment, Parallel Assignment, Safety/Efficacy Study |
| Arthritis, Juvenile Rheumatoid |
- Drug: meloxicam oral suspension
- Drug: naproxen oral suspension
|
| |
| |
| |
| Completed |
| 180 |
|
| June 2003 (final data collection date for primary outcome measure) |
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
|
| Both |
| 2 Years to 17 Years |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United States, Brazil, Mexico, Ukraine |
| |
| NCT00034853 |
| Boehringer Ingelheim, Study Chair, Boehringer Ingelheim |
| 107.235 |
| Boehringer Ingelheim Pharmaceuticals |
|
| Study Chair: |
Boehringer Ingelheim |
Boehringer Ingelheim Pharmaceuticals |
|
|
| Boehringer Ingelheim Pharmaceuticals |
| September 2009 |