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Meloxicam [Mobic] in Juvenile Rheumatoid Arthritis (JRA)

Sponsor
Boehringer Ingelheim (Industry)
Overall Status
Completed
CT.gov ID
NCT00034853
Collaborator
(none)
180
Enrollment
37
Locations
4.9
Patients Per Site

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: meloxicam oral suspension
  • Drug: naproxen oral suspension
 Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
180 participants
Intervention Model:
Parallel Assignment
Primary Purpose:
Treatment
Official 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
Study Start Date :
Dec 1, 2000
Actual Primary Completion Date :
Jun 1, 2003

Outcome Measures

Primary Outcome Measures

  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; [week 12]

Secondary Outcome Measures

  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 [weeks 4, 8, 12, 18, and 24]

Eligibility Criteria

Criteria

Ages Eligible for Study:
2 Years to 17 Years
Sexes Eligible for Study:
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:

  • 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

Locations

Site City State Country Postal Code
1 107.235.23 Arkansas Children's Hospital Little Rock Arkansas United States
2 107.235.17 Valley Children's Hospital Madera California United States
3 107.235.37 San Diego California United States
4 107.235.4 Boehringer Ingelheim Investigational Site Denver Colorado United States
5 107.235.12 Boehringer Ingelheim Investigational Site Hartford Connecticut United States
6 107.235.13 Alfred I. DuPont Hospital for Children Wilmington Delaware United States
7 107.235.36 Arthritis Associates Clinical Research of South Florida Del Ray Beach Florida United States
8 107.235.21 Miami Children's Hospital Miami Florida United States
9 107.235.38 Clinical Research Dept #7006 St. Petersberg Florida United States
10 107.235.8 Boehringer Ingelheim Investigational Site Chicago Illinois United States
11 107.235.7 Boehringer Ingelheim Investigational Site Kansas City Kansas United States
12 107.235.25 University of Louisville Louisville Kentucky United States
13 107.235.16 Children's Hospital - Department of Rheumatology New Orleans Louisiana United States
14 107.235.26 Deparment of Rheumatology Boston Massachusetts United States
15 107.235.2 E15 Mayo Clinic Rochester Minnesota United States
16 107.235.18 Washington University School of Medicine St. Louis Missouri United States
17 107.235.9 Boehringer Ingelheim Investigational Site St. Louis Missouri United States
18 107.235.31 Department of Pediatrics Omaha Nebraska United States
19 107.235.35 Arthritis and Rheumatic Disease Center Livingston New Jersey United States
20 107.235.24 The Children's Hospital of Buffalo Buffalo New York United States
21 107.235.19 Columbia Presbyterian Medical Center New York New York United States
22 107.235.22 Oklahoma Medical Research Foundation Oklahoma City Oklahoma United States
23 107.235.33 Healthcare Research Consultants Tulsa Oklahoma United States
24 107.235.32 Arthritis and Osteoporosis Center Duncansville Pennsylvania United States
25 107.235.39 Division of Ambulatory Pediatrics Providence Rhode Island United States
26 107.235.10 Texas Scottish Rite Hospital Dallas Texas United States
27 107.235.1 University of Utah School of Medicine Salt Lake CIty Utah United States
28 107.235.30 Children's Hospital Seattle Washington United States
29 107.235.20 Medical College of Wisconsin Milwaukee Wisconsin United States
30 107.235.61 Cerqueira César Brazil
31 107.235.62 Santa Cecília Brazil
32 107.235.60 Sao Paulo Brazil
33 107.235.40 México, D.F. Mexico
34 107.235.71 Institute of Children and Adolescents Health Kharkov Ukraine
35 107.235.70 Children Clinical Hospital No. 1 Kiev Ukraine
36 107.235.72 Institute of Pediatrics Kiev Ukraine
37 107.235.73 2nd Children Specialized Clinical Hospital "OHMADIT" Kiev Ukraine

Sponsors and Collaborators

  • Boehringer Ingelheim

Investigators

  • Study Chair: Boehringer Ingelheim, Boehringer Ingelheim

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00034853
Other Study ID Numbers:
  • 107.235
  • NCT00274482
First Posted:
May 3, 2002
Last Update Posted:
Nov 1, 2013
Last Verified:
Oct 1, 2013
Additional relevant MeSH terms:
Arthritis
Arthritis, Juvenile
Naproxen
Meloxicam

Study Results

No Results Posted as of Nov 1, 2013