Клинические исследования в Украине

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Исследования / № 00034853

Краткое названиеMeloxicam [Mobic] in Juvenile Rheumatoid Arthritis (JRA)
Полное названиеSafety and Efficacy of Meloxicam Oral Suspension in JRA (Subtrial of 107.208)
СпонсорBoehringer Ingelheim Pharmaceuticals
ИсточникBoehringer Ingelheim Pharmaceuticals
Под контролемArgentina: Ministry of Health
Brazil: Ministry of Health
Mexico: Ministry of Health
Ukraine: Ministry of Health
United States: Food and Drug Administration
Краткое описаниеSafety and efficacy of meloxicam oral suspension in juvenile rheumatoid arthritis
Дата началаNovember 2000
ФазаPhase 3
Вид исследованияEndpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Primary Purpose: Treatment
КритерииInclusion 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

- 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
Минимальный возраст2 Years
Максимальный возраст17 Years
УсловиеArthritis, Juvenile Rheumatoid
Применяемое лечение
Drugmeloxicam oral suspension
Drugnaproxen oral suspension
Контакты и расположение
Kharkov 107.235.71 Institute of Children and Adolescents Health
Kiev 107.235.73 2nd Children Specialized Clinical Hospital "OHMADIT"
Kiev 107.235.72 Institute of Pediatrics
Kiev 107.235.70 Children Clinical Hospital No. 1
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