NCT02274961Unknown3 期
S-pantoprazole 10mg Phase III Clinical Study
Ahn-Gook Pharmaceuticals Co.,Ltd10 个研究点 分布在 1 个国家目标入组 174 人开始时间: 2014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
- 发起方
- 入组人数
- 174
- 试验地点
- 10
- 主要终点
- To assess the efficacy , as defined by complete resolution of heartburn (HB) per Questionnaire, of 4 weeks of treatment of S-pantoprazole 10mg qd compared to Placebo in subjects with symptomatic gastro-esophageal reflux disease
研究概览
简要总结
This clinical study hypothesized that S-pantoprazole 10mg would be effective to treat Non erosive Reflux Disease than 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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 19 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults between the ages of 19 and 75 inclusive
- •Patient with a history of heartburn or acid regurgitation for at least 3 months.
- •Those with episodes of heartburn for 2 days or more during the last 7 days prior to baseline
- •Patients negative for erosive esophagitis confirmed by esophagogastroduodenoscopy(EGD) performed within 7 days of screening
- •Capable of providing written informed consent, willing and able to a comply with all procedures of the study
排除标准
- •History of endoscopic erosive esophagitis(EE) at screening EGD.
- •Historical evidence of the following disease/conditions : symptom of Irritable bowel syndrome
- •More tha 3cm endoscopic Barrett's esophagus or significant dysplastic changes in the esophagus
- •Proton Pump Inhibitor(PPI) within 4 weeks prior to the baseline visit
- •H2-receptor antagonist, sucralfate, prokinetics, Non Steroidal Antiinflammatory Drugs(NSAIDs) (except low dose aspirin) during the 2 weeks prior to the screening
- •Historical evidence of the following disease/conditions during 3 months: Zollinger-Ellison syndrome, the primary esophageal motility disorders achalasia, esophageal stricture, pancreatitis, gastric ulcer, evidence of upper G.I. malignancy, pancreatitis, malabsorption, severe cardiovascular or pulmonary disease, severe liver disease, severe renal disease, cerebral vascular disease,
- •Known hypersensitivity to any component of drug
- •pregnancy or lactation (F only)
研究组 & 干预措施
S-pantoprazole 10mg
Experimental
S-pantoprazole 10mg Tablet once daily for 4 weeks
干预措施: S-pantoprazole 10mg (Drug)
Placebo
Placebo Comparator
Placebo tablet for the test drug
干预措施: Placebo (Drug)
结局指标
主要结局
To assess the efficacy , as defined by complete resolution of heartburn (HB) per Questionnaire, of 4 weeks of treatment of S-pantoprazole 10mg qd compared to Placebo in subjects with symptomatic gastro-esophageal reflux disease
时间窗: 4 weeks
次要结局
未报告次要终点
研究者
研究点 (10)
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