NCT02755753已完成4 期
A Multicenter, Randomized, Double-blinded, Placebo-controlled Pilot Study to Evaluate the Efficacy and Safety of Rebamipide as an Adjuvant Regimen to Heal erosIve Reflux Esophagitis (REPAIR)
YongChan Lee5 个研究点 分布在 2 个国家目标入组 143 人开始时间: 2014年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 143
- 试验地点
- 5
- 主要终点
- Endoscopic healing rate
研究概览
简要总结
The purpose of this study is to evaluate whether Rebamipide facilitate the healing of inflamed mucosa as an adjuvant regimen in erosive reflux esophagitis (ERE).
详细描述
- To evaluate whether Rebamipide facilitate the healing of inflamed mucosa as an adjuvant regimen in erosive reflux esophagitis patients
- To evaluate the safety of rebamipide as an adjuvant regimen in erosive reflux esophagitis (ERE)
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male/female patients aged 20 to 70 at the time of writing an informed consent.
- •Subjects who were diagnosed with Erosive Reflux Esophagitis (ERE) using Los Angeles (LA) classification grade A~D, confirmed by endoscopy.
- •The subjects regardless of presence of ERE symptom (i.e., symptomatic ERE or asymptomatic ERE).
- •For symptomatic ERE, the subject must have one or more symptoms of the followings: acid regurgitation, heartburn, epigastric pain, cough, hoarseness, globus pharyngis, atypical chest pain.
- •Subjects who have consented to participate in this clinical study by signing an informed consent form.
排除标准
- •Patients with known hypersensitivity to any component of Lanston® and/or Mucosta® formulations.
- •Other concurrent organic upper gastroesophageal disease in endoscopy (i.e., drug-induced esophagitis, viral esophagitis, Mallory-Weiss syndrome, peptic ulcer disease, malignancies) and patients who was diagnosed with Barrett's esophagus.
- •History of abdominal surgery that can affect gastrointestinal motility (except appendectomy and hysterectomy).
- •History of upper gastrointestinal bleeding or obstruction.
- •Patients administrated with any drugs that can affect the efficacy of study regimen (proton pump inhibitors, revaprazan, prokinetics, H2-blockers, etc.) within 2 weeks (however, 4 weeks for PPIs) prior to enrollment and/or those who are required of NSAIDs, anti-coagulants, anti-cholinergics, prostaglandin E, corticosteroids, and anti-depressants treatment during the study period.
- •History of pancreatobiliary disease (except asymptomatic gallbladder stone), inflammatory bowel disease, cirrhotic liver disease, chronic kidney disease.
- •Pregnant, nursing, and childbearing potential women who is unwilling to effective contraception; for example, oral contraceptives, hormonal methods, placement of an intrauterine device (IUD) or intrauterine system (IUS), barrier methods (i.e., condom or occlusive cap with spermicidal foam/gel/film/cream/suppository), male sterilization, and true abstinence.
- •History of psychological disorder, alcoholics, and drug abuser.
- •Blood test results of hemoglobin (Hb) ≤ 10.0 g/dL, platelets ≤ 50,000 /µL, total WBCs ≤ 4,000/µL or ≥ 10,000/µL, and with serum test results showing the levels of AST, ALT, ALP, BUN, and creatinine exceeding twice the normal range of respective institution.
- •Patients who previously underwent another clinical survey within 4 weeks.
- •History of major medical disease that can affect general condition and other patients deemed not eligible for this study by investigators.
研究组 & 干预措施
Study Group
Experimental
- Lanston® (lansoprazole) 30 mg, 1 capsule, PO, qd, 30 min before breakfast
- Mucosta® (rebamipide) 100 mg, 1 tablet, PO, tid, 30 minutes before breakfast, lunch and dinner
干预措施: Lansoprazole (Drug)
Study Group
Experimental
- Lanston® (lansoprazole) 30 mg, 1 capsule, PO, qd, 30 min before breakfast
- Mucosta® (rebamipide) 100 mg, 1 tablet, PO, tid, 30 minutes before breakfast, lunch and dinner
干预措施: Rebamipide (Drug)
Control Group
Placebo Comparator
- Lanston® (lansoprazole) 30 mg, 1 capsule, PO, qd, 30 min before breakfast
- Mucosta®-placebo (rebamipide-placebo), 1 tablet, PO, tid, 30 minutes before breakfast, lunch and dinner
干预措施: Lansoprazole (Drug)
Control Group
Placebo Comparator
- Lanston® (lansoprazole) 30 mg, 1 capsule, PO, qd, 30 min before breakfast
- Mucosta®-placebo (rebamipide-placebo), 1 tablet, PO, tid, 30 minutes before breakfast, lunch and dinner
干预措施: Rebamipide-placebo (Drug)
结局指标
主要结局
Endoscopic healing rate
时间窗: 4 weeks
The ratio of the endoscopically completely healed (normal or minimal change) patients per groups
次要结局
- Histologic change(4 weeks)
- Change in inflammatory cytokines(4 weeks)
- Time to complete symptom relief(every 2 week, up to 4 week)
- Overall symptom relief(every 2 week, up to 4 week)
- Adverse events profile(every 2 week, up to 4week)
研究者
YongChan Lee
Professor
Severance Hospital
研究点 (5)
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