NCT00232089已完成3 期
Assessment of Efficacy and Safety of Tegaserod Treatment and Placebo in Women With 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
- 1,296
- 试验地点
- 2
- 主要终点
- Over 6 weeks of treatment assessment of percent of days with satisfactory relief of dyspepsia and/or average severity score in (average of postprandial fullness early satiety and bloating)
研究概览
简要总结
This study is being done to evaluate the safety, tolerability and satisfactory relief of dyspepsia symptoms in females excluding those with predominant stomach pain. Tegaserod will be evaluated at 6mg twice daily and placebo.
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
- Double
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 patients, 18 years and older
- •Self-reported presence of persistent or recurrent adverse digestive symptoms consistent with dyspepsia; for at least 12 weeks, not necessarily consecutive, during the previous 12 months.
排除标准
- •Abnormal esophago-gastro-duodenoscopy (EGD) endoscopy findings such as any esophageal mucosal break, gastric erosions, gastric ulcers and/or duodenal ulcers/erosions on an EDG exam performed with 12 weeks prior to baseline.
- •Current or history of erosive esophagitis confirmed by EGD
- •Heartburn occurring 3 or more days a week.
- •Other protocol-defined inclusion/exclusion criteria may apply
结局指标
主要结局
Over 6 weeks of treatment assessment of percent of days with satisfactory relief of dyspepsia and/or average severity score in (average of postprandial fullness early satiety and bloating)
次要结局
- Weekly global assessment of change in dyspepsia condition.
- Weekly assessment of satisfactory relief of dyspepsia.
- Weekly assessment of individual symptoms score of postprandial fullness early satiety, bloating, abdominal pain, nausea and vomiting.
- Safety and tolerability.
- For each week assessment of average daily severity score.
- Quality of life at end of treatment compared to baseline.
- Daily assessment of percentage of patients responding on average severity score.
- Percentage of days with satisfactory relief of dyspepsia during each week.
研究者
研究点 (2)
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