Loratadine for Improvement of Bone Pain in Patients With Chronic Granulocyte-Colony Stimulating Factor (G-CSF) Use
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Change in Pain Severity Scores as Measured by the Brief Pain Inventory (BPI)
研究概览
简要总结
G-CSF causes a release of histamine that may be a cause of chronic bone pain. Loratadine targets histamine, and so may be effective in reducing bone pain.The researchers plan to prospectively assess the effectiveness of loratadine for chronic bone pain in patients with chronic G-CSF use.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 99 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of neutropenia
- •Granulocyte-colony stimulating factor (G-CSF) use for at least 3 months at least 4 times per month
- •Mean bone pain of at least a 2/10 as assessed by questions 3-6 of the Brief Pain Inventory (BPI)
排除标准
- •Other sources of chronic pain
- •Previously tried loratadine for 7 consecutive days or more for bone pain
- •Allergy to loratadine
- •Chronic daily usage of antihistamine without an acceptable alternative non-antihistamine medication
研究组 & 干预措施
Loratadine first
Take treatment daily for 7 days.
干预措施: Loratadine (Drug)
Loratadine first
Take treatment daily for 7 days.
干预措施: Placebo (Drug)
Placebo first
Take placebo daily for 7 days.
干预措施: Loratadine (Drug)
Placebo first
Take placebo daily for 7 days.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Pain Severity Scores as Measured by the Brief Pain Inventory (BPI)
时间窗: Week 1 (baseline week), week 2 (placebo or loratadine), and week 4 (placebo or loratadine).
The Brief Pain Inventory (BPI) rapidly assesses the severity of pain and its impact on functioning. The questions ask participants to rate their pain in the prior 24-hours OR prior 7-day on a 0 to 10 Numerical Rating Scale (NRS), where "0" indicates "No pain" and "10" indicates "Pain as bad as you can imagine." Modified BPI: Included the pain intensity subscale, it is a Numerical Rating Scale with 4 questions (3-6): each item is ranked where 0 is no pain - 10 the worst pain. The Modified BPI will be measured on Days 2, 4, and 6. The full BPI will be measured on Day 7. On day 7 only responses from questions 3-6 will be analyzed for this outcome and a mean composite score for Days 2, 4, 6, and 7 will be calculated.
次要结局
- Change in Pain Interference in Patients as Measured by the Brief Pain Inventory (BPI)(Week 1 (baseline week), week 2 (placebo or loratadine), and week 4 (placebo or loratadine).)
研究者
Kelly Walkovich
Associate Professor of Pediatrics and Communicable Diseases
University of Michigan