NCT00171470已完成3 期
The Role of Tegaserod Therapy in the Management of Dyspeptic Symptoms in Female Patients on Proton Pump Inhibitors for the Treatment of Heartburn.
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
- 60
- 试验地点
- 2
- 主要终点
- To determine whether tegaserod administered over 6 weeks results in improved dyspeptic symptoms characterized by epigastric discomfort vs placebo on patients taking PPIs for the treatment of heartburn (weekly global assessment)
研究概览
简要总结
Study to provide initial data to assess the safety and efficacy of tegaserod use in patients with dyspepsia that are being treated with proton pump inhibitors (PPI's) for heartburn.
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 or older.
- •Self-reported presence of symptoms consistent with dyspepsia (including mid-upper abdominal discomfort characterized by post prandial fullness, early satiety and bloating)
- •Stable dose PPI therapy of at least 4 weeks
排除标准
- •History of intestinal obstruction, symptomatic gallbladder disease, suspected sphincter of Oddi dysfunction, or of abdominal adhesions.
- •Evidence that the dyspeptic symptoms are relieved by defecation and/or associated with a change in frequency or stool form.
- •With a current most bothersome symptom of heartburn.
- •Other protocol-defined inclusion/exclusion criteria may apply.
结局指标
主要结局
To determine whether tegaserod administered over 6 weeks results in improved dyspeptic symptoms characterized by epigastric discomfort vs placebo on patients taking PPIs for the treatment of heartburn (weekly global assessment)
次要结局
- Quality of Life (weekly assessment)
- Comparison of tegaserod vs. placebo for individual symptoms severity scores of postmeal fullness, early fullness while eating, bloating, abdominal pain, nausea, vomiting, heartburn, regurgitation and constipation (daily assessment)
- Safety and tolerability
研究者
研究点 (2)
Loading locations...
相似试验
终止
2 期
Assessment of the Effect of Tegaserod (2 mg Tid and 6 mg Tid) on Dyspeptic Symptoms in Diabetic Patients With Symptoms of Diabetic GastropathyDiabetic GastropathyNCT00142974Novartis120
已完成
3 期
Assessment of the Effects of Tegaserod in the Management of Gastroesophageal Reflux Disease (GERD) in Patients With Incomplete Response to Proton Pump Inhibitors (PPIs).Gastroesophageal Reflux Disease (GERD)NCT00171418Novartis54
已完成
3 期
Assessment of Efficacy and Safety of Tegaserod Treatment and Placebo in Women With DyspepsiaDyspepsiaNCT00232024Novartis1,296
已完成
3 期
Assessment of Efficacy and Safety of Tegaserod Treatment and Placebo in Women With DyspepsiaDyspepsiaNCT00232089Novartis1,296
已完成
3 期
Assessment of Efficacy and Safety of Tegaserod in Male Patients With Chronic Constipation.Chronic ConstipationNCT00141089Novartis1,026