NCT01860482已完成4 期
An 8-weeks, Multicenter, Single Arm, Non-comparative, Phase 4 Clinical Trial to Assess the Efficacy and Safety of Newrabell® Tab. at 10mg b.i.d in Patients With Refractory Reflux Esophagitis(rGERD) to the Prior Standard PPIs Regimen
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- Time to onset of first 1Day Heartburn free, Days
研究概览
简要总结
The purpose of this study is to assess the efficacy and safety of Newrabell® Tab. in patients with refractory reflux esophagitis to the prior standard PPIs regimen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or Female aged ≥ 20 years
- •Reflux esophagitis with erosion or ulceration confirmed by endoscopic exam.
- •Refractory reflux esophagitis to PPIs standard treatment as follows
- •Ongoing heartburn symptom with or without these GERD-related symptoms : Regurgitation, Non-cardiac chest pain, Epigastric pain, Belching, Bloating, Satiety, Sore throat, Cough, Laryngitis, Hoarseness, Nausea, Vomiting, Dysphagia, Odynophagia, Weight loss
- •Ongoing heartburn symptom with or without erosion ≥ grade A according to LA Classification
- •Ongoing heartburn symptoms ≥ 2 days during 1week right before administering first dose of IP
- •Decided to participate and signed on an informed consent form willingly
排除标准
- •Existence of upper gastrointestinal bleeding or active gastroduodenal ulcer at screening
- •History of operation in esophagus, stomach or duodenum
- •The following medical history
- •Primary esophageal motility disease, Achalasia, Scleroderma, Esophageal/pyloric stricture, Primary esophageal spasm
- •Barrett's esophagus ≥ 3 cm
- •Zollinger-Ellison syndrome
- •Infectious or inflammatory bowel disease, Severe malabsorption
- •Severe chronic heart failure, cardiovascular disease, renal failure, COPD, asthma, liver cirrhosis
- •History of cancer within 5 years, except completely recovered skin cancer
- •ALT or AST ≥ Upper limit of normal range X 3
- •Need antibiotics due to severe infection
- •Severe medical disease that needs these prohibited medication
- •Anticoagulant(Heparin, Warfarin, etc.), High dose of aspirin(>325mg/d), Digitalis(Digoxin, etc.), Diuretics, Atazanavir, NSAIDs or Steroids
- •Use PPIs or H2RA medicine within 1 week before administering first dose of IP, or need other PPIs or H2RA medicine during trial period
- •Allergy or hypersensitivity to IP or similar chemical structure(Benzimidazol derivatives, etc.)
- •Pregnant or breast-feeding women
- •Conversation impairment because of alcohol, drug addiction or mental illness, etc.
- •Administration of other IP within 28 days
- •Inability to record heartburn diary card
- •In investigator's judgement
研究组 & 干预措施
Newrabell single arm
Experimental
Newrabell® Tablet 10mg b.i.d PO during 8 weeks
干预措施: Newrabell® Tablet 10mg (Drug)
结局指标
主要结局
Time to onset of first 1Day Heartburn free, Days
时间窗: up to 8 weeks
次要结局
- 1Day Heartburn free days, %(up to 8 weeks)
- Time in Daytime of first Heartburn free, Days(up to 8 weeks)
- Time in Nighttime of first Heartburn free, Days(up to 8 weeks)
- Weekly Heartburn Improvement Rate, %(up to 8 weeks)
- Average Daytime and Nighttime Heartburn Score Change at W4(up to 8 weeks)
- Average Daytime and Nighttime Heartburn Score Change at W8(up to 8 weeks)
- Time to onset of first 2Days Heartburn free, Days(up to 8 weeks)
研究者
研究点 (2)
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