TCTR20160517003招募中3 期
A Randomized Controlled Trial of Dexlansoprazole vs. Double Dose Omeprazole in Non-responsive Nonerosive Esophageal Reflux Disease
Faculty of Medicine Siriraj Hospital, Mahidol University0 个研究点目标入组 118 人开始时间: 2016年5月17日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 118
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 Years 至 80 Years（—）
- 性别
- All
入选标准
- •Adult patients (age at least 18 years old) who non-responsive to omeprazole 20 mg once daily were eligible for enrollment in the trial. Non-responsive NERD defined as less than 50% improvement of heartburn or acid regurgitation for 1 days per week during the 30 days before screening while taking omeprazole 20 mg once daily. All patients were performed esophagogastroduodenoscopy that showed no lesion at esophagogastric junction.
排除标准
- •Exclusion criteria included current or historical evidence of esophageal ulcers or strictures, gastric or duodenal ulcers or any other gastric or esophageal pathology judged to be clinically significant by the investigator, significant gastric or esophageal pathology, motility disorder (eg, achalasia, scleroderma, autonomic neuropathy, peripheral neuropathy or myopathy), Active Helicobacter pylori infection. Also excluded were patients who received concurrent medications that interfered esophageal or gastric motility and also gastric pH were excluded, these drug such as NSAIDs, ASA, bisphosphonate, theophylline, bismuth salts, warfarin, phenytoin, barbiturates, antineoplastic agents, erythromycin, clarithromycin, or sucralfate. Patients who experienced history of drug allergy or side effect of proton pump inhibitors. Women were required to be nonpregnant, nonlactating, and using a medically acceptable form of birth control.
研究者
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