A Study to Assess the Efficacy, Safety and Tolerability of Tegaserod Alone and in Combination With Omeprazole Given Orally in Patients With Symptoms of Symptomatic Gastroesophageal Reflux Disease (sGERD)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 832
- 试验地点
- 2
- 主要终点
- Proportion of patients experiencing resolution of heart-burn during week 4 of treatment
研究概览
简要总结
Gastroesophageal Reflux Disease (GERD) is a common disorder caused by the reflux of gastric (stomach) acid into the esophagus. The exposure of the lining of the esophagus to the acid will cause damage to the esophagus over time. The symptoms of GERD include heartburn and acid regurgitation This study will determine if Tegaserod alone and in combination with omeprazole is safe and relieves the symptoms of 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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of physician diagnosed GERD
- •Heartburn and Regurgitation 3 Days during the week prior to screening
排除标准
- •History of erosive esophagitis, Barrett's esophagus, esophageal stricture, scleroderma, Zollinger-Ellison Syndrome, known primary disorder
- •History or presence of infection or inflammation of the small or large intestine, gastrointestinal malignancy, history of upper GI surgery
- •Use of PPI during the last four weeks prior to screening
- •Other protocol-defined inclusion/exclusion criteria may apply.
结局指标
主要结局
Proportion of patients experiencing resolution of heart-burn during week 4 of treatment
Proportion of patients experiencing resolution of heart-burn during week 4 of treatment in combination with Omeprazole and compared with Omeprazole alone
Decreasing frequency of regurgitation during week 4 of treatment
Decreasing frequency of regurgitation during week 4 of treatment in combination with Omeprazole and compared with Omeprazole alone
次要结局
未报告次要终点