Meloxicam [Mobic] in Juvenile Rheumatoid Arthritis (JRA)

Overview

To obtain safety, efficacy, pharmacokinetic and dosing information for meloxicam oral suspension in children with Juvenile Rheumatoid Arthritis (JRA)

Full Title of Study: “A 12 Week Double-blind Randomized Trial, With a 12 Week Open-label Extension, to Investigate the Efficacy and Safety of Meloxicam Oral Suspension Administered Once Daily and Naproxen Oral Suspension Administered Twice Daily in Children With Juvenile Rheumatoid Arthritis”

Study Type

  • Study Type: Interventional
  • Study Design
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
  • Study Primary Completion Date: June 2003

Interventions

  • Drug: meloxicam oral suspension
  • Drug: naproxen oral suspension

Clinical Trial Outcome Measures

Primary 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 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 2 Years

Maximum Age: 17 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Boehringer Ingelheim
  • Provider of Information About this Clinical Study
    • Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
  • Overall Official(s)
    • Boehringer Ingelheim, Study Chair, Boehringer Ingelheim

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