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CompletedNCT00034853Updated Nov 1, 2013

Meloxicam [Mobic] in Juvenile Rheumatoid Arthritis (JRA)

A Phase 3 interventional study of meloxicam oral suspension and naproxen oral suspension in Arthritis, Juvenile Rheumatoid, sponsored by Boehringer Ingelheim. Completed at 37 sites in 4 countries. Open to participants aged 2 Years to 17 Years. Per ClinicalTrials.gov, last updated 2013-11-01.

Sponsored by Boehringer Ingelheim · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
180
Ages
2 Years to 17 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Arthritis, Juvenile Rheumatoid
03

In context

Arthritis

3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.

This study's planned enrollment of 180 is above the median of 90 across 2,377 interventional studies indexed under Arthritis.

Browse Arthritis studies →

Lead sponsor

Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.

Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Phase 3
Primary purpose
Treatment
Intervention model
Parallel assignment
Enrollment
180 participants (estimated)

Interventions

  • Drugmeloxicam oral suspension
  • Drugnaproxen oral suspension
06

What researchers measure

Primary outcomes

  1. 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

  1. 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

07

Study locations

37 sites
  • 107.235.23 Arkansas Children's Hospital
    Little Rock, Arkansas, United States
  • 107.235.17 Valley Children's Hospital
    Madera, California, United States
  • 107.235.37
    San Diego, California, United States
  • 107.235.4 Boehringer Ingelheim Investigational Site
    Denver, Colorado, United States
  • 107.235.12 Boehringer Ingelheim Investigational Site
    Hartford, Connecticut, United States
  • 107.235.13 Alfred I. DuPont Hospital for Children
    Wilmington, Delaware, United States
  • 107.235.36 Arthritis Associates Clinical Research of South Florida
    Del Ray Beach, Florida, United States
  • 107.235.21 Miami Children's Hospital
    Miami, Florida, United States
  • 107.235.38 Clinical Research Dept #7006
    St. Petersberg, Florida, United States
  • 107.235.8 Boehringer Ingelheim Investigational Site
    Chicago, Illinois, United States
  • 107.235.7 Boehringer Ingelheim Investigational Site
    Kansas City, Kansas, United States
  • 107.235.25 University of Louisville
    Louisville, Kentucky, United States
  • 107.235.16 Children's Hospital - Department of Rheumatology
    New Orleans, Louisiana, United States
  • 107.235.26 Deparment of Rheumatology
    Boston, Massachusetts, United States
  • 107.235.2 E15 Mayo Clinic
    Rochester, Minnesota, United States
  • 107.235.18 Washington University School of Medicine
    St. Louis, Missouri, United States
  • 107.235.9 Boehringer Ingelheim Investigational Site
    St. Louis, Missouri, United States
  • 107.235.31 Department of Pediatrics
    Omaha, Nebraska, United States
  • 107.235.35 Arthritis and Rheumatic Disease Center
    Livingston, New Jersey, United States
  • 107.235.24 The Children's Hospital of Buffalo
    Buffalo, New York, United States
  • 107.235.19 Columbia Presbyterian Medical Center
    New York, New York, United States
  • 107.235.22 Oklahoma Medical Research Foundation
    Oklahoma City, Oklahoma, United States
  • 107.235.33 Healthcare Research Consultants
    Tulsa, Oklahoma, United States
  • 107.235.32 Arthritis and Osteoporosis Center
    Duncansville, Pennsylvania, United States
  • 107.235.39 Division of Ambulatory Pediatrics
    Providence, Rhode Island, United States
  • 107.235.10 Texas Scottish Rite Hospital
    Dallas, Texas, United States
  • 107.235.1 University of Utah School of Medicine
    Salt Lake CIty, Utah, United States
  • 107.235.30 Children's Hospital
    Seattle, Washington, United States
  • 107.235.20 Medical College of Wisconsin
    Milwaukee, Wisconsin, United States
  • 107.235.61
    Cerqueira César, Brazil
  • 107.235.62
    Santa Cecília, Brazil
  • 107.235.60
    Sao Paulo, Brazil
  • 107.235.40
    México, D.F., Mexico
  • 107.235.71 Institute of Children and Adolescents Health
    Kharkov, Ukraine
  • 107.235.70 Children Clinical Hospital No. 1
    Kiev, Ukraine
  • 107.235.72 Institute of Pediatrics
    Kiev, Ukraine
  • 107.235.73 2nd Children Specialized Clinical Hospital "OHMADIT"
    Kiev, Ukraine
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 1, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00034853
Lead sponsor
Boehringer Ingelheim
First posted
May 3, 2002
Start date
Dec 2000
Primary completion
Jun 2003
Last update
Nov 1, 2013

Study contacts

Boehringer Ingelheim
study chair · Boehringer Ingelheim
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2013. You cannot join it, but the record below documents what was studied.

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