NCT00099177终止3 期
A Randomized, Double-blind Study of the Effect of Bondronat Compared With Zoledronic Acid on Pain in Patients With Malignant Bone Disease Experiencing Moderate to Severe Pain
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 96
- 主要终点
- Pain, as measured by Brief Pain Inventory and analgesic use
研究概览
简要总结
This 2 arm study will compare the efficacy of a regimen of intravenous (iv) and oral Bondronat with that of zoledronic acid in patients with malignant bone disease experiencing moderate to severe pain. Patients will be randomized to receive either Bondronat (6mg iv on days 1, 2 and 3 followed by Bondronat 5Omg po daily from day 22 to week 24) or zoledronic acid (4mg iv on day 1, and then every 3-4 weeks). The anticipated time of study treatment is 6-12 months, and the target sample size is 100-500 individuals.
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
- Double
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with malignant bone disease;
- •patients with moderate to severe pain.
排除标准
- •patients who have received a bisphosphonate within 3 weeks from the signing of informed consent;
- •patients receiving concurrent investigational therapy, or who have received investigational therapy within 30 days of the first scheduled day of dosing;
- •untreated esophagitis or gastric ulcers;
- •recent or pre-scheduled radiotherapy to bone;
- •patients who are pregnant or breast-feeding.
研究组 & 干预措施
1
Experimental
干预措施: ibandronate [Bondronat] (Drug)
2
Active Comparator
干预措施: zoledronic acid (Drug)
结局指标
主要结局
Pain, as measured by Brief Pain Inventory and analgesic use
时间窗: Week 24
次要结局
- Skeletal-related events(Throughout study)
- Performance score and QoL measures(Week 24)
- AEs and laboratory parameters(Throughout study)
- Opioid side effects(Throughout study)
研究者
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