Comparison of Nexium Versus Secretol in the Healing and Controlling of Symptoms in Gastroesophageal Reflux Disease(GERD)Patients With Severe Erosive Esophagitis(EE).
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Primary objective is to evaluate the relationship between healing and study drug allotment.
研究概览
简要总结
To compare the complete healing of erosive esophagitis(EE) after 3 weeks of treatment with Secretol 80/80 versus Nexium 40 mg daily.
详细描述
We hypothesize that Secretol 80/80 daily will demonstrate better efficacy than Nexium 40 mg daily in healing erosive esophagitis(EE)and controlling gastroesophageal reflux disease(GERD)related symptoms after 3 weeks of treatment.In addition, Secretol 80/80 daily will have a faster effect on the aforementioned clinical parameters but a similar safety profile.
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 (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or Female
- •Ages 18-75
- •EE Los Angeles grades C or D
- •Heartburn and/or regurgitation at least 3 times a week during the 7 day run- in period prior to randomization.
- •Able to read, understand, and complete study questionnaires and record
- •Able to understand the study procedures and sign informed consent
- •Able to comply with all study requirements
排除标准
- •Subjects with Barrett's esophagus, non-erosive reflux disease,EE grades A or B, or peptic stricture on endoscopy
- •Subjects with previous upper gastrointestinal surgery
- •Subjects with clinically significant underlying comorbidity
- •Helicobacter pylori positive
- •Clinically significant GI bleed within the last 3 months
- •Esophagitis not related to acid reflux
- •Bleeding disorder
- •Zollinger-Ellison, achalasia,esophageal varices, duodenal/gastric ulcer, upper gastrointestinal malignancy
- •Women pregnant or lactating
- •History of allergic reaction to any Proton Pump Inhibitor (PPI)
- •Patients can't be treated concurrently with warfarin or other anticoagulants,salicylates,steroids,NSAIDS > 3 times/week
- •Any medication dependant on gastric acid for optimal absorption
研究组 & 干预措施
Nexium
Comparing 40 mg.once daily in healing erosive esophagitis.
干预措施: Nexium (Drug)
Secretol
Comparing the efficacy of 80/80 Secretol once daily in healing erosive esophagitis.
干预措施: Secretol (Drug)
结局指标
主要结局
Primary objective is to evaluate the relationship between healing and study drug allotment.
时间窗: 3 weeks of treatment
The primary objective is to evaluate the relationship between healing and study drug allotment. The variables to be used are erosive esophagitis healing status after 3 weeks of treatment as assessed by EGD (upper endoscopy) comparing to base line EGD.
次要结局
未报告次要终点