Meloxicam [Mobic] in Juvenile Rheumatoid Arthritis (JRA)

October 31, 2013 updated by: Boehringer Ingelheim

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
180

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Cerqueira César, Brazil
        • 107.235.61
      • Santa Cecília, Brazil
        • 107.235.62
      • Sao Paulo, Brazil
        • 107.235.60
  • Mexico
      • México, D.F., Mexico
        • 107.235.40
  • Ukraine
      • Kharkov, Ukraine
        • 107.235.71 Institute of Children and Adolescents Health
      • Kiev, 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"
  • United States
    • Arkansas
      • Little Rock, Arkansas, United States
        • 107.235.23 Arkansas Children's Hospital
    • California
      • Madera, California, United States
        • 107.235.17 Valley Children's Hospital
      • San Diego, California, United States
        • 107.235.37
    • Colorado
      • Denver, Colorado, United States
        • 107.235.4 Boehringer Ingelheim Investigational Site
    • Connecticut
      • Hartford, Connecticut, United States
        • 107.235.12 Boehringer Ingelheim Investigational Site
    • Delaware
      • Wilmington, Delaware, United States
        • 107.235.13 Alfred I. DuPont Hospital for Children
    • Florida
      • Del Ray Beach, Florida, United States
        • 107.235.36 Arthritis Associates Clinical Research of South Florida
      • Miami, Florida, United States
        • 107.235.21 Miami Children's Hospital
      • St. Petersberg, Florida, United States
        • 107.235.38 Clinical Research Dept #7006
    • Illinois
      • Chicago, Illinois, United States
        • 107.235.8 Boehringer Ingelheim Investigational Site
    • Kansas
      • Kansas City, Kansas, United States
        • 107.235.7 Boehringer Ingelheim Investigational Site
    • Kentucky
      • Louisville, Kentucky, United States
        • 107.235.25 University of Louisville
    • Louisiana
      • New Orleans, Louisiana, United States
        • 107.235.16 Children's Hospital - Department of Rheumatology
    • Massachusetts
      • Boston, Massachusetts, United States
        • 107.235.26 Deparment of Rheumatology
    • Minnesota
      • Rochester, Minnesota, United States
        • 107.235.2 E15 Mayo Clinic
    • Missouri
      • St. Louis, Missouri, United States
        • 107.235.18 Washington University School of Medicine
      • St. Louis, Missouri, United States
        • 107.235.9 Boehringer Ingelheim Investigational Site
    • Nebraska
      • Omaha, Nebraska, United States
        • 107.235.31 Department of Pediatrics
    • New Jersey
      • Livingston, New Jersey, United States
        • 107.235.35 Arthritis and Rheumatic Disease Center
    • New York
      • Buffalo, New York, United States
        • 107.235.24 The Children's Hospital of Buffalo
      • New York, New York, United States
        • 107.235.19 Columbia Presbyterian Medical Center
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
        • 107.235.22 Oklahoma Medical Research Foundation
      • Tulsa, Oklahoma, United States
        • 107.235.33 Healthcare Research Consultants
    • Pennsylvania
      • Duncansville, Pennsylvania, United States
        • 107.235.32 Arthritis and Osteoporosis Center
    • Rhode Island
      • Providence, Rhode Island, United States
        • 107.235.39 Division of Ambulatory Pediatrics
    • Texas
      • Dallas, Texas, United States
        • 107.235.10 Texas Scottish Rite Hospital
    • Utah
      • Salt Lake CIty, Utah, United States
        • 107.235.1 University of Utah School of Medicine
    • Washington
      • Seattle, Washington, United States
        • 107.235.30 Children's Hospital
    • Wisconsin
      • Milwaukee, Wisconsin, United States
        • 107.235.20 Medical College of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

2 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Interventional Model: Parallel Assignment

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
week 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
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
weeks 4, 8, 12, 18, and 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2000

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2003

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 2, 2002

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 2, 2002

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 3, 2002

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 1, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 31, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 107.235

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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