NCT01471925撤回3 期
A Phase III, Randomized, Open-label, Superiority Study Comparing the Incremental Product Esomeprazole Associated With Sodium Bicarbonate Made by Eurofarma and Nexium® in the Treatment of Gastroesophageal Reflux Disease
Eurofarma Laboratorios S.A.6 个研究点 分布在 1 个国家开始时间: 2011年11月16日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 试验地点
- 6
- 主要终点
- Efficacy
研究概览
简要总结
A phase III, randomized, open-label, superiority study comparing the incremental product esomeprazole associated with sodium bicarbonate made by Eurofarma and Nexium® in the treatment of gastroesophageal reflux disease. The study will enroll 94 patients in each arm (total of 188 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ICF signing;
- •Age ≥ 18 years;
- •Gastroesophageal reflux disease diagnosis;
- •Grade 0 to grade III reflux esophagitis, assessed by means of upper gastrointestinal endoscopy;
- •Ability to have the endoscopy, pH-metry and esophageal manometry examinations performed;
- •Washout period of 1 week without using PPI, H2 antagonists and prokinetic agents and of at least 1 day without using antacids.
排除标准
- •Presence of esophagitis requiring intervention (grade IV), esophageal varices, Barrett's esophagus, systemic sclerosis or ulcers (gastric or duodenal ulcers);
- •Previous gastric or esophageal surgery;
- •Dietary sodium restriction, metabolic alkalosis, hypokalemia, Barter syndrome; Pregnancy or breastfeeding;
- •Concomitant diseases, such as kidney, liver and heart failure;
- •Suspected or confirmed cancer of any type;
- •Abusive drug or alcohol use;
- •Abnormal values for white blood cells, platelets or hemoglobin;
- •Significant changes in serum sodium, potassium, calcium or creatinine concentrations;
- •Treatment with PPI, H2 antagonists or prokinetic agents that may not be withheld during the washout period of 1 week or during the study;
- •Intolerance or allergy to any of the components in the drug products assessed in the study;
- •Use of nonsteroidal anti-inflammatory drugs (NSAIDs), antiemetic agents, macrolide antibiotics and systemic corticoids for a period equal to or greater than 2 weeks before the study or that is expected to require prolonged use during study treatment;
- •Concomitant use or requirement of a gastric pH-dependent medication for optimal absorption;
- •Scheduled use of other medications metabolized by cytochrome CYP during the study;
- •History of active peptic ulcer;
- •Rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltase insufficiency;
- •Recent participation (within the last 12 months) in another clinical study.
研究组 & 干预措施
Esomeprazole (40mg) + Sodium Bicarbonate (721mg)
Experimental
干预措施: Esomeprazol (40mg) + Sodium Bicarbonate (721mg) (Drug)
Nexium®
Active Comparator
干预措施: Nexium® (Drug)
结局指标
主要结局
Efficacy
时间窗: 1 month
Primary efficacy analysis the value for intragastric pH 10 centimeters distant from the lower esophageal sphincter and the pH value 1 hour after using study medication during randomization visit will be considered for primary study assessment.
次要结局
未报告次要终点
研究者
研究点 (6)
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