NCT01015404已完成3 期
A Study to Assess the Safety of Using Fibroblast Growth Factor-2 With Periodontal Surgery in Japan (Phase 3)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 6
- 主要终点
- serum Trafermin level
研究概览
简要总结
This study aims to investigate the safety in using Trafermin (recombinant human basic fibroblast growth factor) with periodontal surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Vertical intrabony defect from radiographs at baseline
- •Age of 20 years or older
排除标准
- •Using an investigational drug within the past 24 months
- •Coexisting malignant tumour or history of the same
- •Coexisting diabetes (HbA1C 6.5% or more)
- •Taking bisphosphonates
- •Coexisting gingival overgrowth or history of the same
研究组 & 干预措施
Experimental H
Experimental
high volume (0.6mL、0.3% Trafermin)
干预措施: Trafermin (Drug)
Experimental L
Experimental
low volume (0.2mL、0.3% Trafermin)
干预措施: Trafermin (Drug)
结局指标
主要结局
serum Trafermin level
时间窗: within 4 weeks
次要结局
- occurrence and level of adverse reaction(within 4 weeks)
- serum anti-Trafermin antibody level(within 4 weeks)
研究者
研究点 (6)
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