JPRN-jRCT2080222489已完成3 期
A Double-blind Comparative Study of the Efficacy and Safety of E3810 10mg Once and Twice Daily in Maintenance Therapy for PPI Resistant Gastroesophageal Reflux Disease Patients
EA Pharma Co., Ltd., Eisai Co., Ltd.0 个研究点目标入组 517 人开始时间: 2014年5月22日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 517
研究概览
简要总结
In the maintenance treatment of PPI-resistant reflux esophagitis, after endoscopically healed with E3810 10 mg BID or 20 mg BID for 8 weeks, followed by maintenance therapy with E3810 for 52 weeks, E3810 10 mg BID exerted a stronger recurrence-preventing effect than 10 mg QD over 52 weeks. No particular safety issues were noted during 52-week administration.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1.Patients diagnosed with gastroesophageal reflux disease who are shown through endoscopic examination to have mucosal lesions (erosions, ulcers)
- •2.Patients over 20 years of age who have freely given their informed consent in writing to participation in the study.
- •3.Patients who, having received a full explanation of the matters that must be adhered to during the study, intend to adhere to their requirements, and are capable of doing so.
排除标准
- •1.Patients considered candidates for surgical treatment of the upper gastrointestinal tract due to perforation, esophageal stricture, pyloric stenosis, esophageal varices, etc.
- •2.Patients with Zollinger-Ellison syndrome.
- •3.Patients with gastrointestinal hemorrhage.
- •4.Patients with serious cardiovascular disease, cerebrovascular disease, hematological disorders, renal disease, liver disease, malignant tumors, etc.
- •5.Patients with long segment Barrett's esophagus.
- •6.Patients with open gastric or duodenal ulcers.
- •7.Patients with drug allergies or a past history of drug allergies to PPI.
- •8.Patients who are taking other drugs under development, or have done so within 12 weeks prior to enrollment.
- •9.Patients who are, or may be pregnant, patients who wish to become pregnant during the study period, patients who are breastfeeding, and patients or their partners who do not wish to use reliable contraceptive measures.
- •10.Patients with a history of dependence on or abuse of drugs or alcohol within the past two years.
- •11.Other patients deemed unsuitable for inclusion in the study by the principal investigator or sub-investigators.
研究者
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