临床试验/NCT00232011

NCT00232011已完成3 期

A Clinical Study Continued From the Confirmatory Study to Assess the Efficacy and Safety of ASM981 Cream in Adult Atopic Dermatitis Patients

Novartis1 个研究点分布在 1 个国家目标入组 160 人开始时间: 2004年5月最近更新: 2007年12月17日

适应症

干预措施

试验速览

阶段: 3 期
状态: 已完成
发起方: Novartis
入组人数: 160
试验地点: 1
主要终点: Safety assessed by adverse events (AEs)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Pimecrolimus, which is an ascomycin derivative, is an anti-inflammatory non-steroidal agent. In this study, the long-term safety and efficacy of pimecrolimus cream will be evaluated in Japanese adult patients with atopic dermatitis. This study is a 6-month extension study following core study.

THIS STUDY IS NOT ENROLLING PATIENTS IN THE UNITED STATES

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Single Group
主要目的: Treatment
盲法: None

入排标准

年龄范围: 16 Years 至 65 Years（Child, Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Patients who had completed the core study and whose participation in this study was considered appropriate as judged by the investigator
•Patients who had given written informed consent to participation in this study

排除标准

•Patients who failed in treatment compliance in the core study
•Patients who had a major violation of the protocol in the core study

研究组 & 干预措施

1

Experimental

干预措施: Pimecrolimus Cream 1% (Drug)

结局指标

主要结局

Safety assessed by adverse events (AEs)

次要结局

Number of disease flares during 26 weeks of treatment

研究者

发起方

Novartis

申办方类型

Industry

研究点 (1)

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