Verification Study of Ciclosporin for Atopic Dermatitis

Novartis Pharmaceuticals0 个研究点开始时间: 2004年5月1日最近更新: 2011年11月2日

适应症

试验速览

阶段: 3 期
状态: 已完成
发起方: Novartis Pharmaceuticals

研究概览研究设计入排标准研究者记录与标识符相似试验

研究概览

简要总结

To assess the efficacy and safety of oral OL27-400MEPC 3 mg/kg/day (2-5 mg/kg/day) in 2 divided doses daily for 8 weeks to patients with severe adult atopic dermatitis.

THIS STUDY IS NOT ENROLLING PATIENTS IN THE UNITED STATES

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Single Group
主要目的: Treatment
盲法: Double

入排标准

年龄范围: 20 Years 至 64 Years（Adult）
性别: All
接受健康志愿者: 否

入选标准

•Appropriate the definition/diagnosis criteria of atopic dermatitis of the Japanese Dermatological Association
•Patients with severest atopic dermatitis [according to the "Guidelines for Treatment of Atopic Dermatitis 2002, the severity of atopic dermatitis will be classified as severest when an eruption associated with severe inflammation (a lesion associated with erythema, papule, erosion, infiltration, lichenification, etc.) is noted on at least 30% of body surface on the day of subject enrollment].

排除标准

•- Patients who received oral preparations, injections, inhaled preparations and suppositories of steroids or immunosuppressants other than tacrolimus hydrate ointments within 14 days of subject enrollment
•Patients who might receive the oral/injection drugs which are known to enhance nephrotoxicity, increase serum potassium levels, HMG-CoA reductase inhibitors or theophylline during the treatment period.
•Patients who received or are receiving an ultraviolet therapy (PUVA therapy, etc.)
•Patients with hypertension, active infectional disease, gout etc. Other protocol-defined exclusion criteria may apply

研究者

发起方

Novartis Pharmaceuticals

申办方类型

Industry

责任方

Sponsor

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