JPRN-jRCT2080221947未知3 期
A Multicentre, Randomised, Double-blind, Parallel-group, Comparative Study to Compare the Efficacy and Safety of D961H 20 mg Twice Daily Oral Administration and D961H 20 mg Once Daily Oral Administration in Patients With Refractory Reflux Esophagitis
适应症
试验速览
- 阶段
- 3 期
- 发起方
- AstraZeneca
研究概览
简要总结
暂无简介。
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
- •Provision of informed consent prior to any study specific procedures.
- •-Patients with RE classified into LA classification Grade A, B, C or D by Endoscopy despite of at least 8-week treatment using standard doses of PPIs.
- •-Patients must fulfill at least one of the following criteria such as (i) RE with LA grade C/D at Endoscopy on visit 1 and/or history of RE with LA grade C/D, (ii) RE was diagnosed more than 1 year before visit 1.
- •-Patients who are able to complete the Patient Diary
排除标准
- •-Male or female aged less than 20 years at the time of informed consent.
- •-Patients with current evidence of the gastrointestinal diseases/conditions such as esophageal stricture to interfere with the evaluation of the study etc
- •-Gastric or duodenal ulcer verified by Endoscopy within 12 weeks before randomisation.
- •-Previous esophageal, gastric or duodenal surgery except simple closure of perforated ulcer, simple endoscopic treatment with simple operation etc
- •-Current or historical evidence (within 12 weeks prior to randomisation ) of the diseases/conditions as judged to interfere with the evaluation of the study.
研究者
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