JPRN-jRCTs031200417招募中4 期
Multicenter prospective randomized controlled trial of Vonoprazan and Esomeprazole in initial treatment for reflux esophagitis: Focusing on recurrence during maintenance therapy - VERET study
Matsumura Tomoaki0 个研究点目标入组 120 人开始时间: 2021年3月12日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 120
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
- •Patients who meet all of the following criteria will
- •be included:
- •1) Patients with reflux esophagitis: patients with erosive esophagitis of Los Angeles classification grade A-D with endoscopic examination.
- •2) Patients with hearburn symptoms
- •3) Age of 20 years or older (any gender).
- •4) Patients who have been fully informed of and have obtained written consent of their own free will
- •to participate in the study
排除标准
- •Applicants who meet any of the following conditions are not eligible
- •1) Highly obese patients with a body mass index (BMI) of 35 or higher
- •2) Patients with hiatus hernia (3cm or more)
- •3) Patients taking other antacids, including PPIs (e.g. histamine H2 receptor antagonists) within 14 days prior to obtaining consent
- •4) Patients who have taken regular NSAIDs, including glucocorticosteroids and COX-2 inhibitors, on at least 3 consecutive days per week within the past 28 days; exception: regular intake of up to 150 mg/day of acetylsalicylic acid.
- •5) Patients with a history of esophageal, gastric or duodenal surgery.
- •6) Patients with esophageal stenosis
- •7) Patients with scleroderma
- •8) Patients who may have an allergic reaction to the study drug
- •9) Patients with substance abuse or health, psychological, or social conditions that interfere with participation in the study and the evaluation of results
- •10) Pregnant women, lactating women, and patients who may or will become pregnant (a pregnancy test should be performed if pregnancy is suspected)
- •11) Patients who are deemed unsuitable for inclusion by the principal investigator or sub-physician.
研究者
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