CTRI/2019/02/017388已完成2 期
A randomized double blind controlled trial assessing the dose response and safety of Deflazacort in boys with Duchenne muscular dystrophy - DOSE
Dr Renu Suthar0 个研究点目标入组 97 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 97
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Boys with a diagnosis of DMD: ( two should present)
- •1With phenotypic characteristic symptoms or signs (waddling gait, Gowerâ??s sign, and calf hypertrophy)
- •2Elevated CK, and positive genetic analysis of dystrophin gene or muscle biopsy that demonstrated a clear alteration in dystrophin amount or distribution in the muscle
- •3.He should be ambulatory at the time of enrolment
- •4.Baseline 6MWD should be more than 150 meters
- •5.Steroid naive patients or who have received <6 months of any form of steroid therapy in immediate past
- •6.Willing for functional assessment and follow up in the clinic
排除标准
- •1.Prior long-term use of oral GCs for >6 months
- •2.Active peptic ulcer disease or history of any gastrointestinal or perforation
- •3.Boys with DMD and autism/ intellectual disability/ fractures
- •4.Not willing for giving written informed consent
研究者
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