Meloxicam [Mobic] in Juvenile Rheumatoi… | Clinical Trial

Key information

Conditions

Arthritis, Juvenile Rheumatoid Arthritis Arthritis, Juvenile Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

2 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

107.235.61, Cerqueira César, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

meloxicam oral suspension

Drug

naproxen oral suspension

Drug

Primary outcomes

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 outcomes

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

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study 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

Important dates

Study start: 2000
Primary completion: 2003
First posted: May 3, 2002
Registry last updated: Nov 1, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed