NCT00502736已完成2 期
An Open Label Study to Assess the Effect of Intravenous Loading Doses of Bondronat on Bone Pain in Patients With Breast Cancer and Skeletal Metastases
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
- 13
- 主要终点
- Pain and analgesic consumption
研究概览
简要总结
This single arm study will assess the efficacy and safety of loading doses of intravenous Bondronat in patients with breast cancer and malignant bone disease experiencing moderate to severe bone pain. Patients will receive an intravenous infusion of 6mg Bondronat on days 1, 2 and 3. The anticipated time on study treatment is 3 months, and the target sample size is <100 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 patients, >=18 years of age;
- •breast cancer;
- •bone metastases;
- •moderate to severe pain;
- •adequate renal function.
排除标准
- •bisphosphonate treatment within 3 weeks of study enrollment.
研究组 & 干预措施
1
Experimental
干预措施: ibandronate [Bondronat] (Drug)
结局指标
主要结局
Pain and analgesic consumption
时间窗: Days 1, 7 and 14
次要结局
- AEs and laboratory parameters(Days 1, 4 and 7)
- Karnofsky index(Day 7)
- Serum creatinine(Days 1, 4 and 7)
研究者
相似试验
撤回
2 期
A Study of Loading Doses of Intravenous Bondronat (Ibandronate) in Patients With Breast Cancer and Metastatic Bone Disease.PainBone NeoplasmNeoplasm MetastasisNCT00478270Hoffmann-La Roche
已完成
3 期
A Study of Ibandronate (Bondronat) in Participants With Malignant Bone DiseasePain; Bone Neoplasms; Neoplasm MetastasisNCT02561039Hoffmann-La Roche97
已完成
3 期
A Study of Intravenous Mircera in Participants With Chronic Renal Anemia Who Are on DialysisAnemiaNCT00660023Hoffmann-La Roche124
已完成
1 期
Sildenafil IV Bolus StudyHypertension, PulmonaryNCT00800592Pfizer's Upjohn has merged with Mylan to form Viatris Inc.12
尚未招募
1 期
Study on the Treatment of Advanced Malignant Solid Tumor With Revottack and PD-1 InhibitorAdvanced Solid TumorNCT05644509The Affiliated Hospital of Xuzhou Medical University10