Phase III Randomized, Double-Blind Study of Prednisone for Duchenne Muscular Dystrophy

National Center for Research Resources (NCRR)0 个研究点目标入组 20 人开始时间: 1995年4月1日最近更新: 2005年6月24日

适应症

试验速览

阶段: 3 期
状态: 已完成
发起方
入组人数: 20

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

OBJECTIVES: I. Characterize the effect of prednisone on muscle protein metabolism in patients with Duchenne muscular dystrophy.

II. Determine whether prednisone changes levels of insulin-like growth factor 1, growth hormone, and insulin.

III. Characterize the effect of prednisone on muscle morphometry and muscle localization of utrophin.

IV. Compare the prednisone response in patients with Duchenne muscular dystrophy to that seen in normal individuals and in patients with facioscapulohumeral dystrophy.

详细描述

PROTOCOL OUTLINE: This is a randomized, double-blind study. Patients are randomly assigned to prednisone or placebo. Therapy is administered daily for 12 weeks; prednisone is then tapered.

研究设计

研究类型: Interventional
分配方式: Randomized
主要目的: Treatment
盲法: Double

入排标准

年龄范围: 5 Years 至 15 Years（Child）
性别: Male
接受健康志愿者: 否

入选标准

•PROTOCOL ENTRY CRITERIA:
•Ambulatory males with Duchenne muscular dystrophy
•No medical/psychiatric contraindication to protocol therapy
•No requirement for regular use of prescription medication

排除标准

未提供

研究者

发起方

National Center for Research Resources (NCRR)

申办方类型

Nih

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