NCT02553707已完成4 期
Open-Label Study to Establish the Short Term Efficacy of Intravenous Loading-Doses of Bondronat 6 mg in Patients With Breast Cancer and Skeletal Metastases Experiencing Moderate to Severe Pain, Within 7 Days After Initiation of Treatment
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 182
- 主要终点
- Percentage of participants with =<35% increase in mean analgesic consumption
研究概览
简要总结
This study will assess the short term efficacy of ibandronate (6 mg intravenous [IV]) in participants with breast cancer and malignant bone disease, with moderate to severe pain. All participants will receive an IV infusion of ibandronate on Days 1, 2, and 3, and pain response will be measured on Days 1-7. The anticipated time on study treatment is 3 days, and the target sample size is 182 individuals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female participants greater than or equal to (>=) 18 years of age
- •Breast cancer with bone metastases
- •Pain score of >=4 on Worst Pain scale of Brief Pain Inventory (BPI)
- •Stable analgesic regimen.
排除标准
- •Participants who have received a bisphosphonate within 3 weeks of start of trial
- •Radiotherapy to bone within 4 weeks of enrolment
- •Hypersensitivity to ibandronate
- •Central nervous system (CNS) or meningeal metastases
研究组 & 干预措施
Ibandronate
Experimental
Participants will receive ibandronate 6 mg IV on Days 1, 2, and 3.
干预措施: Ibandronate (Drug)
结局指标
主要结局
Percentage of participants with =<35% increase in mean analgesic consumption
时间窗: up to Days 7
Percentage of participants with >=25% reduction in mean pain
时间窗: up to Day 6
次要结局
- Change from Baseline in average pain score(Baseline (Days 0), 5, and 7)
- Pain response(up to Day 7)
- Analgesic consumption(up to Day 7)
- Time to pain response(up to Day 7)
研究者
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