NCT00504426已完成2 期
Dose-ranging Trial of OPC-249 Powder Inhalation in Patients With Pain Due to Osteoporosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 101
- 主要终点
- Pain (Subjective Symptom)
研究概览
简要总结
The purpose of this study is to examine the efficacy and safety of OPC-249 by once daily inhalation at 0 (placebo), 30, 60 or 120 IU for 4 weeks in patients with pain due to osteoporosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 46 Years 至 79 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients who fulfill all of the following items
- •Patients with primary osteoporosis
- •Patients who have existing 1-4 vertebral fractures
- •Patients with back pain persisting for one week or more
- •Postmenopausal women between 46 and less than 80 years of age
排除标准
- 未提供
研究组 & 干预措施
1
Placebo Comparator
干预措施: OPC-249 (Drug)
2
Active Comparator
干预措施: OPC-249 (Drug)
3
Active Comparator
干预措施: OPC-249 (Drug)
4
Active Comparator
干预措施: OPC-249 (Drug)
结局指标
主要结局
Pain (Subjective Symptom)
时间窗: Baseline and Week 4
Change of pain measured by 100 mm visual analogue scale (VAS) at week4 from baseline. Regarding VAS (dotted onto a 100 mm line), 0 mm means "No Pain" and 100 mm means "Worst Pain Imaginable".
次要结局
- Improvement Rate of Pain (Doctor's Judgment)(Baseline and Week 4)
研究者
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未知
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