NCT03006874已完成3 期
A Double Blind, Randomized, Active-controlled, Phase 3 Study to Confirm the Safety and Efficacy of CJ-12420 in Patients With Erosive Esophagitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 302
- 试验地点
- 1
- 主要终点
- Cumulative healing rate of erosive esophagitis at 8-week
研究概览
简要总结
The purpose of this study is to confirm the efficacy of CJ-12420, Once daily (QD), compared to esomeprazole in patients with erosive esophagitis classified as Los Angeles (LA) classification grades A to D at Week 8.
详细描述
This is a double blind, randomized, active controlled, phase 3 study. Subjects will be randomly assigned to one of the three treatment groups (CJ-12420 50mg, CJ-12420 100mg, esomeprazole 40mg).
All subjects will be asked to take three tablets at the same time each day throughout the study, and also all subjects will be asked to record daytime and nighttime symptom in a subject diary on a daily basis.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects aged between 20 and 75 years
- •Endoscopically confirmed erosive esophagitis as defined by LA Classification Grading System (A-D) within 14 days prior to randomization
- •Subjects who had experienced heartburn and regurgitation within 7 days before visit 1
- •Subjects who is able to understand and follow the instructions and is willing to participate throughout the entire study
- •Subjects who voluntarily signed written informed consent form
- •Subjects who agreed to use medically acceptable contraceptives during the period of study
排除标准
- •Subjects who cannot undergo EGD
- •Subjects who have esophageal stenosis, ulcer stenosis, gastroesophageal varices, Barrett's esophagus, active gastric ulcer, gastrointestinal bleeding or malignant tumor confirmed by EGD
- •Subjects who have warning symptoms of malignant gastrointestinal tract such as odynophagia, severe dysphagia, bleeding, weight loss, anemia, or bloody stool
- •Subjects with eosinophilic esophagitis
- •Subjects diagnosed with primary esophageal motility disorder, IBS, IBD, etc. or with suspected IBS in the last 3 months
- •Subjects who have a history of gastric acid suppression surgery or upper gastrointestinal, esophageal surgery
- •Subjects who have AIDS or Hepatitis
- •Subjects who take antipsychotic drugs, antidepressant drug, antianxiety drug
- •Subjects who take gastric acid suppression like PPI within 2 weeks to EGD
- •Subjects who take medications related to reflux esophagitis more than 2 times within 1 weeks to EGD
- •Requirement of persistent daily use of drugs that may cause an ulcer such as nonsteroidal anti-inflammatory drugs(NSAIDs) or aspirin during the course of the study
- •Pregnant or lactating women
- •Subjects with the following clinically significant laboratory abnormalities
- •Subjects with the following clinically significant ECG abnormalities
- •Sollinger-Ellison syndrome patients
- •Subjects with a history of malignant tumor
- •Subjects with a history of clinically significant hepatic, renal, cardiovascular, respiratory, endocrine and CNS system disorder
- •Subjects with a history of hypersensitivity to the active ingredient or excipients of the study drug, etc
- •Scheduled surgery requiring hospitalization or requirement of surgical treatment during study participation
- •Subjects who participated in the other clinical trial within 4 weeks prior to randomization
- •Subjects who are judged unsuitable to participate in the study in the opinion of the investigator
研究组 & 干预措施
CJ-12420 50mg QD
Experimental
CJ-12420 50mg tablet, once daily, oral administration for up to 8 weeks.
干预措施: CJ-12420 50mg QD (Drug)
CJ-12420 100mg QD
Experimental
CJ-12420 100mg tablet, once daily, oral administration for up to 8 weeks.
干预措施: CJ-12420 100mg QD (Drug)
Esomeprazole 40mg
Active Comparator
Esomeprazole 40mg, tablet. once daily, oral administration for up to 8 weeks.
干预措施: Esomeprazole 40mg (Drug)
结局指标
主要结局
Cumulative healing rate of erosive esophagitis at 8-week
时间窗: 8 week
次要结局
- Healing rate of erosive esophagitis at 4-week(4-week)
- Symptom assessment by questionnaire(4-week or 8-week)
- Symptom assessment by subject diary(4-week or 8-week)
研究者
研究点 (1)
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