NCT00659100已完成3 期
A 3-Month, Open-Label, Pharmacy-Based, Actual-Use Trial in a Simulated Over-The-Counter (OTC) Environment to Assess Self-Selection and Consumer Use Patterns of Gabapentin 250 mg for Occasional Sleeplessness
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.1 个研究点 分布在 1 个国家目标入组 1,254 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
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,254
- 试验地点
- 1
- 主要终点
- Subject compliance with directions for use (number of capsules per dose and the number of doses per day)
研究概览
简要总结
The purpose of this study is to assess consumers' behaviors related to gabapentin self- selection and use, relative to warnings and directions for use, as described in the proposed over-the-counter (OTC) product label.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age of 18 years or older with symptoms of sleeplessness
- •Provided informed consent
排除标准
- •Contraindications to use of gabapentin
研究组 & 干预措施
A
Experimental
干预措施: Gabapentin (Drug)
结局指标
主要结局
Subject compliance with directions for use (number of capsules per dose and the number of doses per day)
时间窗: Throughout Day 90
Proportion of subjects who selected or purchased gabapentin for use (patients had symptoms consistent with indication and no contraindications)
时间窗: Throughout Day 90
次要结局
- Adverse events(Duration of study)
研究者
研究点 (1)
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