Meloxicam [Mobic] in Juvenile Rheumatoid Arthritis (JRA)

This study has been completed.

Sponsor:

Information provided by:

Boehringer Ingelheim Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT00034853

First received: May 2, 2002

Last updated: May 11, 2012

Last verified: May 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

May 2, 2002

Last Updated Date

May 11, 2012

Start Date ^ICMJE

November 2000

Primary Completion Date

June 2003 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00034853 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Meloxicam [Mobic] in Juvenile Rheumatoid Arthritis (JRA)

Official Title ^ICMJE

Safety and Efficacy of Meloxicam Oral Suspension in JRA (Subtrial of 107.208)

Brief Summary

Safety and efficacy of meloxicam oral suspension in juvenile rheumatoid arthritis

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment

Condition ^ICMJE

Arthritis, Juvenile Rheumatoid

Intervention ^ICMJE

Drug: meloxicam oral suspension
Drug: naproxen oral suspension

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

180

Completion Date

Not Provided

Primary Completion Date

June 2003 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

2 Years to 17 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Brazil, Mexico, Ukraine

Administrative Information

NCT Number ^ICMJE

NCT00034853

Other Study ID Numbers ^ICMJE

107.235

Has Data Monitoring Committee

Not Provided

Responsible Party

Boehringer Ingelheim, Study Chair, Boehringer Ingelheim

Study Sponsor ^ICMJE

Boehringer Ingelheim Pharmaceuticals

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:

Boehringer Ingelheim

Boehringer Ingelheim Pharmaceuticals

Information Provided By

Boehringer Ingelheim Pharmaceuticals

Verification Date

May 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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