NCT01150162已完成3 期
A Prospective Randomized, Multi-center Study to Assess the Safety and Efficacy of Mucosta (Rebamipide), in Combination With Omeprazole as Adjuvant Therapy in Gastric Ulcer Patients
Otsuka Pakistan Limited3 个研究点 分布在 1 个国家目标入组 129 人开始时间: 2010年10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
- 129
- 试验地点
- 3
- 主要终点
- Healing rates for gastric ulcer patients via endoscopic examination
研究概览
简要总结
A Prospective Randomized, Multi-center study to assess the Safety and Efficacy of Mucosta (Rebamipide), in combination with Omeprazole as adjuvant therapy in Gastric Ulcer Patients.
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with dyspepsia or epigastric pain and endoscopically proven gastric and duodenal ulcers
- •Required laboratory parameters and time limits (screening blood tests will be taken including hemoglobin, white blood cell count, random glucose, potassium, sodium, chlorine, creatinine, AST, ALT, bilirubin, and alkaline phosphatase)
- •Age > 18 years
- •A statement that all patients must have signed an informed consent form prior to registration in study
排除标准
- •Patients who had undergone surgery for ulcers
- •History of hypersensitivity to drugs to be used in the study
- •Women who are pregnant or lactating or intended to get pregnant during the study period
研究组 & 干预措施
Mucosta and Omeprazole
Experimental
干预措施: Rebamipide and Omeprazole (Drug)
Omeperazole
Active Comparator
干预措施: Omeprazole (Drug)
结局指标
主要结局
Healing rates for gastric ulcer patients via endoscopic examination
时间窗: 8 weeks treatment plus 4 weeks follow-up
Improvement or absence of gastric ulcer associated symptoms
时间窗: 8 weeks treatment plus 4 weeks follow-up
Improvement or absence of gastric ulcer associated symptoms, i.e. pain, burning, etc.
次要结局
- To determine and compare the Safety profile in both the treatment arms.(8 weeks treatment plus 4 weeks follow-up)
研究者
研究点 (3)
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