Meloxicam [Mobic] in Juvenile Rheumatoid Arthritis (JRA) - Full Text View

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:

MedlinePlus related topics: Juvenile Rheumatoid Arthritis Rheumatoid Arthritis

Drug Information available for: Naproxen Naproxen sodium Meloxicam

U.S. FDA Resources

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

Sponsors and Collaborators

Boehringer Ingelheim Pharmaceuticals

Investigators

Study Chair:

Boehringer Ingelheim

Boehringer Ingelheim Pharmaceuticals

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

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 30, 2009