Phase 1 Study of Zoledronic Acid in Sickle Cell Disease
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- The long-term goal of this project is to learn if Zoledronic Acid can prevent or reduce pain in sickle cell disease.
研究概览
简要总结
The long-term goal of this study is to learn if Zoledronic Acid can prevent or reduce pain in sickle cell disease. The goal of this study is to learn about the safety of Zoledronic Acid in persons with sickle cell disease who experience chronic pain requiring medical treatment or use of narcotics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years and older
- •Male or female with sickle cell disease
- •Pain related to sickle cell disease Patient history of health services utilization for acute SCD-related pain Patient history of use of narcotic analgesics for pain control within the past 6 months
- •Able to tolerate hydration with 500 mL D51/2 NS prior to Zoledronic Acid or placebo
排除标准
- •Calculated creatinine clearance less than 60 mL/min
- •Current active dental problems
- •Recent (within 6 weeks) or planned dental or jaw surgery (e.g., extraction,implants)
- •History of cirrhosis or chronic symptomatic liver disease; acute liver disease
- •History of aspirin-induced asthma
- •History of allergy to zoledronic acid or similar chemical-entities
- •Pregnant or nursing
- •No prior bisphosphonate use
- •Receipt of an investigational drug within 30 days
研究组 & 干预措施
2
Patients will receive a single dose of Zoledronic Acid or placebo. The chances that a subject will receive placebo are 1 out of 3.
干预措施: Placebo (Drug)
1
Patients will receive a single dose of Zoledronic Acid or placebo. The chances that a subject will receive Zolendronic Acid are 2 out of 3.
干预措施: Zoledronic Acid (Drug)
结局指标
主要结局
The long-term goal of this project is to learn if Zoledronic Acid can prevent or reduce pain in sickle cell disease.
时间窗: Within 2 weeks of study drug administration and then every month for approximately 1 year
次要结局
- The specific purposes of this study are to learn if Zoledronic Acid has serious side effects for subjects with sickle cell disease and to study the effects of Zoledronic acid in subjects with sickle cell disease.(Two weeks after study drug administration and then every month for approximately 1 year)