Meloxicam [Mobic] in Juvenile Rheumatoid Arthritis (JRA)
This study has been completed.
Sponsor:
Boehringer Ingelheim Pharmaceuticals
Information provided by:
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00034853
First received: May 2, 2002
Last updated: May 11, 2012
Last verified: May 2012
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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 3 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Primary Purpose: Treatment |
| 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
Show 37 Study Locations
Show 37 Study LocationsSponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
| Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
More Information
Additional Information:
No publications provided
| Responsible Party: | Boehringer Ingelheim, Study Chair, Boehringer Ingelheim |
| ClinicalTrials.gov Identifier: | NCT00034853 History of Changes |
| Obsolete Identifiers: | NCT00274482 |
| Other Study ID Numbers: | 107.235 |
| Study First Received: | May 2, 2002 |
| Last Updated: | May 11, 2012 |
| 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:
|
Arthritis Arthritis, Rheumatoid Arthritis, Juvenile Rheumatoid Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Naproxen Meloxicam Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic |
Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Gout Suppressants Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Central Nervous System Agents |
ClinicalTrials.gov processed this record on June 17, 2013