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Клинические исследования в Украине

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Исследования / № 00034853

Описание
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
Industry
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
СостояниеЗавершено
Дата началаNovember 2000
ФазаPhase 3
Вид исследованияEndpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Primary Purpose: Treatment
Набор0
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
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
ПолBoth
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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