NCT00337272终止4 期
Phase IV: Treatment of Chronic Insomnia in Patients With Breast Cancer Following Completion of Chemotherapy
Accelerated Community Oncology Research Network10 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2006年8月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 16
- 试验地点
- 10
- 主要终点
- Sleep Efficiency
研究概览
简要总结
This study is being conducted to evaluate the effectiveness of ramelteon 8mgs in the treatment of insomnia in patients that have completed their first chemotherapy treatment for breast cancer.
详细描述
Phase IV, randomized, double-blind, placebo-controlled, parallel-group study to assess the efficacy of ramelteon 8mgs in the treatment of insomnia in patients with breast cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 21 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients aged 21-60 years old
- •Have a negative serum or urine pregnancy test for women of child-bearing potential
- •Have a three-month or longer history of insomnia
- •Self-report < 6.5 hours of total sleep time, in addition to a sleep efficiency of less than 85%, averaged over two weeks of screening
- •A score of less than 60 on the Zung Self-Rating Depression Scale
- •Self-report bedtimes that do not vary by more than two hours on five nights per week
- •Have completed chemotherapy for breast cancer less than two years prior to study drug administration
- •Have completed chemotherapy for breast cancer for at least two months prior to screening visit
- •Patients that are receiving Herceptin are eligible for study enrollment
- •Have completed radiation therapy for breast cancer for at least two months prior to screening visit
- •ECOG (Eastern Cooperative Oncology Group)score of 0-1
- •Be able to read, understand, and provide written informed consent before enrolling in the study
- •Must be willing to comply with all study visits and comply with daily phone calls to the IVRS throughout the study
- •Agree to participate for the entire study period (about two months)
排除标准
- •Metastatic disease
- •Pregnant or lactating female
- •Self-reports typical consumption of more than five alcoholic beverages on a single day or greater than 14 alcoholic beverages weekly
- •Self-reports use of products containing nicotine of greater than 15 cigarettes daily or cannot avoid products containing nicotine during sleep periods
- •Current use of any of the following medications, and cannot discontinue these medications for the duration of the study: Hypnotic medication, Anti-convulsants, Anxiolytics, Narcotic analgesics, Medications or supplements containing Melatonin, Ketaconazole and Fluconazole
- •Currently taking fluvoxamine, brand name Luvox
- •Have symptoms consistent with the diagnosis of any other sleep disorder other than insomnia (e.g. obstructive sleep apnea, narcolepsy, restless legs syndrome)
- •Currently on night or rotating shift work
- •Self-reports habitual napping of greater than one hour accumulated sleep on 4 or more days per week
- •Has a psychiatric illness that interferes with normal sleep-wake function (e.g. major depression, post-traumatic stress disorder)
- •A score of 60 or greater on the Zung Self-Rating Depression Scale
- •Has current unstable medical disorder, such as symptomatic congestive heart failure, uncontrolled cardiac arrhythmia, or other serious medical condition as determined by the Investigator
研究组 & 干预措施
1 (Placebo)
Placebo Comparator
Patients will take placebo 30 minutes before bedtime days 1-28 of treatment period.
干预措施: Placebo (Drug)
2 (Ramelteon)
Active Comparator
Patients will take 8 mgs of ramelteon 30 minutes before bedtime days 1-28 of treatment period.
干预措施: Ramelteon (Drug)
结局指标
主要结局
Sleep Efficiency
时间窗: Every morning during the screening, treatment, and withdrawal periods
Total time in bed is calculated as the time the subject got out of bed minus the time the subject went to bed. The total sleep time is reported by the subject. Percent sleep efficiency is calulated as 100\*(total sleep time divided by total time in bed).
次要结局
- Quantitative Sleep Parameters - Total Sleep Time(Every morning during the screening, treatment, and withdrawal periods)
- Quantitative Sleep Parameters - Number of Awakenings(Every morning during the screening, treatment, and withdrawal periods)
- Qualitative Evaluation of Sleep - Global Sleep Impression(Once during the withdrawal period)
- Qualitative Evaluation of Sleep - Quality of Sleep(Every morning during the screening, treatment, and withdrawal periods)
- Daytime Function - Fatigue(Once during the screening period; once during the treatment period; twice during the withdrawal period for a total of 4 assessments)
- Daytime Function - Despair(Once during the screening period; once during the treatment period; twice during the withdrawal period for a total of 4 assessments)
- Daytime Function - Distress(Once during the screening period; once during the treatment period; twice during the withdrawal period for a total of 4 assessments)
研究者
研究点 (10)
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