CTRI/2011/091/000026已完成3 期
?A Comparative, Randomized, Open-label, and Multi-Center Clinical Phase III Trial to Investigate the Safety and Efficacy of Etizolam CR 1.5 mg Tablet in comparison with Etizolam 0.5 mg Tablet in Subjects with Chronic Anxiety and Insomnia."
Precise Biopharma Pvt Ltd4 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2010年1月12日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 4
- 主要终点
- ?Change in mean latency in persistent sleep [LPS] measured by polysomnography (PSG) recording in the hospital between day 0 and day 7.
研究概览
简要总结
This study is A Comparative, Randomized, Open-label, and Multi-Center Clinical Phase III Trial to Investigate the Safety and Efficacy of Etizolam CR 1.5 mg Tablet in comparison with Etizolam 0.5 mg Tablet in Subjects with Chronic Anxiety and Insomnia that will be conducted in four centres in India.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
入选标准
- •■All patients with duly filled and signed in ICFs [Informed Consent Forms] ■Ages: > 18 years and < 65 years ■Genders Eligible for Study: both ■Confirmed diagnosis of primary insomnia (as defined by the Diagnostic and Statistical Manual for Mental Disorders-IV [DSM-IV-TR]) present at the time of evaluation for at least 3 months ■Subjects will be eligible to continue in the double-blind treatment phase if they have a mean LPS ≥20 minutes on the 2 nights of PSG monitoring, with an LPS of no less than 15 minutes on either night.
排除标准
- •■Patients unwilling to sign on ICF■Patients having participated in any previous studies of Etizolam, or having taken any other investigational drug within 30 days, ■Patients having sleep schedule changes associated with shift work ■Medications or supplements known to affect sleep-wake function must not have been taken within 5 days or 5 half-lives of the start of the study.
- •■Patients with a history of sleep apnea, chronic obstructive pulmonary disease, seizures, anxiety, depression, schizophrenia, bipolar disorder, mental retardation, a cognitive disorder, ■Patients with history of significant neurological, hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, hematologic, or metabolic diseases (unless controlled with protocol-allowed medications) ■Patients with history of drug addiction or abuse within 12 months of the study.
- •■At screening, if patients have an apnea-hypopnea index >10 or a periodic leg movement arousal index >
- •■Active malignant disease or current cytostatic treatment ■Known severe renal insufficiency ■Liver disease expected to have any potential impact on survival, or elevated A ST or ALT > 2x upper limit of normal ■Recent unstable cardiovascular disease or history of myocardial infarction within the last 3 months ■Pre-menopausal women who are pregnant or nursing, or are of child-bearing potential and are not practicing or do not plan to continue practicing acceptable methods of birth control ■Patients with a history of chronic hepatitis B or C infection, HIV infection.
结局指标
主要结局
?Change in mean latency in persistent sleep [LPS] measured by polysomnography (PSG) recording in the hospital between day 0 and day 7.
时间窗: day 7
次要结局
- To be assessed by polysomnography to record change between day 0 and day 7.?Total Sleep Time [TST] ?Sleep Efficiency. ?Wake Time after Persistent Sleep Onset.?Number of Awakenings after Persistent Sleep. To be assessed by subject sleep diary and sleep questionnaire?Subjective Sleep Latency. ?Subjective Total Sleep ?Subjective Sleep Quality. ?Subjective Wake Time after Sleep Onset. ?Subjective Number of Awakenings. ?Subjective Ease of Falling Back to Sleep after Awakening. ?Stage 1 Nonrapid Eye Movement (NREM) Sleep ?Stage 2 Nonrapid Eye Movement (NREM) Sleep ?Stage 3/4 Nonrapid Eye Movement (NREM) Sleep ?Latency to Rapid Eye Movement (REM) Sleep ?Percentage of Total Sleep Time in REM Sleep(day 7)
研究者
研究点 (4)
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