A Phase III Randomized, Double-Blind, Placebo-Controlled Trial of Gabapentin in the Management of Hot Flashes in Men
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 223
- 试验地点
- 165
- 主要终点
- Hot flash reduction by diary scores at 4 weeks
研究概览
简要总结
RATIONALE: Gabapentin may be effective in relieving hot flashes in men who have prostate cancer. It is not yet known which regimen of gabapentin is most effective in treating hot flashes.
PURPOSE: Randomized phase III trial to compare different regimens of gabapentin in treating men who have prostate cancer.
详细描述
OBJECTIVES:
- Determine the effectiveness of gabapentin in managing hot flashes in men with prostate cancer.
- Determine the response of patients to this drug.
- Determine the toxicity of this drug in these patients.
- Determine the quality of life of patients treated with this drug.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to the number of hot flashes per day (2-3 vs 4-9 vs 10 or more) and duration of hot flash symptoms (less than 9 months vs 9 months or more). Patients are randomized to one of four treatment arms.
All patients are observed for 7 days prior to drug administration in order to collect baseline hot flash information.
- Arm I: Patients receive oral gabapentin once daily on days 1-28.
- Arm II: Patients receive oral gabapentin once daily on days 1-7 and twice daily on days 8-28.
- Arm III: Patients receive oral gabapentin once daily on days 1-7, twice daily on days 8-14, and three times daily on days 15-28.
- Arm IV: Patients receive oral placebo on one of three schedules corresponding to arms I-III.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Gabapentin (28 days)
Oral Gabapentin 300 mg days 1-28
干预措施: gabapentin (Drug)
Gabapentin (7, 21)
Oral Gabapentin 300 mg once daily on days 1-7 days and twice daily days 8-28
干预措施: gabapentin (Drug)
Gabapentin (7, 7, 14)
Oral Gabapentin 300 mg once daily on days 1-7, twice daily on days 8-14 and three times daily on days 15-28
干预措施: gabapentin (Drug)
Placebo
Oral Placebo 300 mg on one of the following schedules:
- once daily on days 1-28
- once daily on days 1-7, twice daily on days 8-28
- once daily on days 1-7, twice daily on days 8-14 and three times daily on days 15-28
干预措施: placebo (Other)
结局指标
主要结局
Hot flash reduction by diary scores at 4 weeks
时间窗: 5 weeks from study entry
次要结局
- Toxicity by questionnaires at 4 weeks(5 weeks from study entry)