A Pilot Study Comparing Clinical Efficacy of One-Week Dual Delayed-Release Dexlansoprazole 60 mg and Esomeprazole 40 mg for Gastroesophageal Reflux Disease Grade A and B
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 175
- 主要终点
- Rate of complete symptom resolution (CSR)
研究概览
简要总结
Rapid onset of proton-pump inhibitors to achieve a fast symptom is an unmet need in treating gastroesophageal reflux disease (GERD) but there was no report on the short-term clinical effects and timing to symptom relief comparing dexlansoprazole 60 mg to esomeprazole 40 mg. This pilot study aims to compare the one-week clinical effects of single doses of the two drugs in treating GERD patients.
详细描述
A comparative study to different PPIs in pharmacokinetic change showing that after 12-24 hours post dose, mean percentage of time with pH > 4 and average of mean pH were greater for dexlansoprazole than esomeprazole . However, the study did not report the clinical effect after tablets used. There was no report on the short-term clinical effects and timing to symptom relief of gastroesophageal reflux disease (GERD) between dexlansoprazole 60 mg and esomeprazole 40 mg. Therefore, we conducted a randomized controlled, open-label, study to compare the 7-day clinical effects of single doses of dexlansoprazole 60 mg and esomeprazole 40 mg in for GERD.
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
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with clinical symptoms of acid regurgitation, heart burn, or feeling of acidity in the stomach, who have Los Angeles Grade A and B erosive esophagitis proven by endoscopy were recruited
排除标准
- •taking antisecretory agents, such as PPIs and histamine-2 receptor antagonists within 2 week prior to the endoscopy
- •coexistence of peptic ulcer or gastrointestinal malignancies
- •pregnancy
- •coexistence of serious concomitant illness (for example, decompensated liver cirrhosis and uremia),
- •previous gastric surgery
- •allergy to dexlansoprazole or esomeprazole
- •symptom score of a validated questionnaire (Chinese GERDQ) less than 12
研究组 & 干预措施
dexlansoprazole group
dexlansoprazole 60mg
干预措施: Dexlansoprazole group (Drug)
esomeprazole group
esomeprazole 40mg
干预措施: Esomeprazole group (Drug)
结局指标
主要结局
Rate of complete symptom resolution (CSR)
时间窗: 1 week after finishing study drug
Evaluate the complete symptom resolution by questionnaire
次要结局
- Rate of symptom relapse(12 weeks after finishing study drug)