EUCTR2011-003646-41-AT进行中（未招募）1 期
Pilotstudy: randomized, open label, single-center study to investigate the efficacy and safety of NT 201 for the prophylaxis of relapse after advancement of the mandible
Oliver Ploder MD, DDS, PhD0 个研究点开始时间: 2011年11月24日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Female or male individuals with mandibular retrognathia, aged = 18 complying with the following main inclusion criteria:
- •- mandibular retrognathia with more than 5 mm discrepancy, measured via standardized x-ray and measurement methods for orthognathic surgery
- •- not allergic against BTX-A
- •- no muscle diseases (eg Myasthenia gravis, Lambert-Eaton-Syndrom) or muscle atrophy
- •- no infection at the localization of injection
- •- no taking of anticoagulations
- •- no pregnancy or breast feeding
- •- no dysphagia
- •- written consent
- •- fully capable
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 60
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •If patients do not meet inclusion criteria
研究者
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