NCT01024192已完成4 期
Efficacy and Safety Assessment of ZOlpidem (Stilnox CR) Administered on as Needed Basis in Patients With Chronic insomNIA
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 135
- 试验地点
- 1
- 主要终点
- Improvement of the Clinical Global Impression (CGI) score
研究概览
简要总结
Primary Objective:
To evaluate the efficacy and safety of the use of Stilnox CR in Mexican patients with chronic insomnia at the prescription conditions of daily practice
Secondary Objective:
To evaluate the satisfaction of the patient with chronic insomnia with Stilnox CR over an as needed basis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary insomnia diagnosis (difficulty for initiating sleep, or maintaining sleep to wake up to early in the morning, or to present a restless sleep) which causes clinically significant disturbances in the areas of social, work functioning or other important areas
- •Exclusion criteria:
- •Serious, severe and/or acute respiratory impairment
- •Severe liver impairment
- •Hypersensitivity to the formulation components or to some of its active metabolites
- •Pregnant or breast-feeding women Patients with important associated disorders in SNC and specially psychotic disorders
- •Patients with the probability of using alcoholic beverages concomitantly (as a precaution measure)
- •Chronic use of benzodiazepines
- •Moreover, in order to follow the international regulations in terms of the use and handling of hypnotic compounds, and to guarantee the appropriate study performance, no patients with one or more of the following characteristics should be included:
- •Patients who cannot comply to follow-up
- •Patients who have any drug abuse problem
- •Individuals who work changing night shifts or with pathological snoring
- •Presence (or suspicion) of sleep apnea, periodical legs movements or restless legs syndrome
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
排除标准
- 未提供
研究组 & 干预措施
1
Experimental
Zolpidem 12.5mg tablet at bed time during 12 weeks
干预措施: ZOLPIDEM SL800750 (Drug)
结局指标
主要结局
Improvement of the Clinical Global Impression (CGI) score
时间窗: At day 84 (visit 5)
次要结局
- Illness severity and average change during the study(At day 1 (baseline), day 14 (visit 2), day 28 (visit 3), day 56 (visit 4) and day 84 (visit 5))
- Pittsburgh Sleep Quality Index (PSQI) score(At day 1 (baseline), day 28 (visit 3), day 56 (visit 4) and day 84 (visit 5))
- Patient satisfaction questionnaire(At day 84 (visit 5))
- Safety evaluation via Adverse events reported(At day 14 (visit 2), day 28 (visit 3), day 56 (visit 4) and day 84 (visit 5))
研究者
研究点 (1)
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