NCT00232037已完成3 期
Extension Study to Assess the Long-Term Safety of Tegaserod in Women With Symptoms of Dyspepsia
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 359
- 试验地点
- 2
- 主要终点
- Long term safety at 6 months.
研究概览
简要总结
This study is being done to evaluate the long-term safety of tegaserod in women with symptoms of dyspepsia who have completed the core study. Tegaserod will be evaluated at 6 mg twice daily.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Female, 18 years and older
- •Fulfilled eligibility criteria in CHTF919D2301 (double blind study) and successfully completed the double-blind study
排除标准
- •- Early discontinuation from the double-blind study
- •Other protocol-defined inclusion/exclusion criteria may apply
结局指标
主要结局
Long term safety at 6 months.
次要结局
- Long term safety at 1 year.
- Quality of life : Nepean Dyspepsia Index, WPAI, patient perception of study medication-dyspepsia questionaire.
- Efficacy on satisfactory relief at month 6 and 12.
研究者
研究点 (2)
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