NCT05443984已完成3 期
A Randomized, Double-blind, Parallel, Active-controlled, Non-inferiority, Phase III Multiple Center Clinical Trial to Compare the Efficacy and Safety of JP-1366 20 mg Versus Esomeprazole 40 mg 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
- 300
- 试验地点
- 1
- 主要终点
- The cumulative healing rate of mucosal break at 8-week after the investigational product administration (%)
研究概览
简要总结
To evaluate the efficacy and safety of JP-1366 20 mg compared to esomeprazole 40 mg in patients with erosive esophagitis
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must satisfy all the following criteria.
- •Male or female, ≥ 19 years of age at the time of obtaining consent
- •Subjects who had experienced heartburn and regurgitation within 7 days prior to the screening visit, those whose severity and frequency of symptoms fall under the following (1) or (2)
- •⑴ Subjects who have experienced mild or more severe heartburn or regurgitation at least twice a week
- •⑵ Subjects who have experienced moderate or more severe heartburn or regurgitation at least once a week
- •Endoscopically confirmed grade A or higher erosive esophagitis as defined by †LosAngeles classification within 15 days, prior to randomization
- •Subjects who fully understand this study and voluntarily signed on the informed consent form
排除标准
- •Subjects may not satisfy any of the following criteria.
- •Subjects who can't undergo endoscopy
- •Medical History
- •º Subjects who have warning symptoms of the malignant gastrointestinal tract such as odynophagia, severe dysphagia, bleeding, weight loss, anemia, or bloody stool. (except negative result for malignancy by endoscopy)
- •º Subjects with eosinophilic esophagitis (except negative result by esophageal biopsy)
- •º Subjects who have esophageal stenosis, gastroesophageal varices, Barrett's esophagus, active gastric ulcer, gastrointestinal bleeding, or malignant tumor confirmed by EGD
- •º Zollinger-Ellison syndrome patients
- •º Subjects diagnosed with primary esophageal motility disorder, irritable bowel syndrome (IBS), inflammatory bowel disease (IBD), or suspected with IBS in the last 3 months and with a current history of the disease including pancreatitis
- •º Subjects who have a history of gastric acid suppression surgery, gastrointestinal or esophageal surgery (except appendectomy, cholecystectomy, polypectomy)
- •º Subjects with a history of clinically significant hepatic, renal, cardiovascular, respiratory, endocrine, urinary, neuro-psychiatric, hemato-oncologic disorder
- •º Subjects who have a history of malignant tumor in 5 years at the time of screening. However, excluding subjects with malignant gastrointestinal cancer regardless of the period.
- •Laboratory Test
- •Screening laboratory test showing any of the following abnormal laboratory results:
- •º ALT or AST > 2.0 x ULN
- •º ALP or GGT > 2.0 x ULN
- •º Total bilirubin > 2.0 x ULN
- •º eGFR<70 mL/min/1.73 m2 (CKD-EPI formula)
- •º Positive result for Serological test (HBsAg, HCV Ab, HIV Ab, Syphilis reagin test)
- •º Clinically significant ECG abnormalities
- •Allergy and drug hypersensitivity
- •º Known hypersensitivity to the active ingredient or excipients of the investigational product
- •º Clinically significant allergies (except mild allergic rhinitis) or hypersensitivity history to drugs. (Aspirin, antibiotics, etc.)
- •Prohibited medication and therapy
- •º Subjects who take gastric acid suppressant like P-CAB, PPI within 2weeks prior to EGD of screening procedure
- •º Subjects who take medication (antacids, prokinetics, H2RA, etc.) related to reflux esophagitis more than 2times within 1week prior to EGD of screening procedure
- •º Subjects who need to take medication (aspirin, NSAIDs, etc.) that may cause an ulcer, during the study period
- •º Subjects who are on or need to be on the medications which categorized as contraindicated in this clinical trial.
- •However, subjects who are on the contraindicated medications can participate in the trial after the washout period of 2 weeks. If five times of the half-life of the contraindicated medications exceeds 2 weeks, the washout period will be set as five times of the half-life.
- •Pregnant and lactating women
- •Contraception Subjects who do not agree to use medically acceptable methods of contraception during the period study
- •Subjects with clinically significant psychiatric disorder and a history with a drug and alcohol abuse.
- •Subjects who are judged unsuitable to participate in the study in the opinion of the investigator
研究组 & 干预措施
Experimental Group
Experimental
JP-1366 20mg + Esomeprazole 40mg(placebo)
干预措施: JP-1366 20mg (Drug)
Active Comparative Group
Active Comparator
JP-1366 20mg(placebo) + Esomeprazole 40mg
干预措施: Esomeprazole 40mg (Drug)
结局指标
主要结局
The cumulative healing rate of mucosal break at 8-week after the investigational product administration (%)
时间窗: Week 8
The proportion of subjects with remission on endoscopy at 8-week
次要结局
- The cumulative Healing rate of mucosal break evaluated by an independent evaluator at the 8-week after the investigational product administration(Week 8)
- Gastro-esophageal symptoms assessment through subject diary at 4, 8 weeks(within 24hours after IP administration, during 7days after IP administration, Week 4 and 8)
- Symptom assessment according to the RDQ questionnaire(Week 4 and 8)
- Healing rate of mucosal break at the 4-week after the investigational product administration(Week 4)
- Healing rate of mucosal break evaluated by an independent evaluator at the 4-week after the investigational product administration(Week 4)
- Change from baseline in the total score of GERD-HRQL at 4, 8-week and cumulative changes in quality of life at 8week(Week 4 and 8)
研究者
研究点 (1)
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