Meloxicam [Mobic] in Juvenile Rheumatoid Arthritis (JRA)

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00034853
First received: May 2, 2002
Last updated: October 31, 2013
Last verified: October 2013
  Purpose

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


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: 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

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

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: December 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00034853

  Show 37 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  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: October 31, 2013
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
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 October 19, 2014