Multi-National, Multi-Centric, Prospective, Randomized, Double-Blind, Active-controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Tegoprazan in Patients with Erosive Gastroesophageal Reflux Disease
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 254
- 试验地点
- 14
- 主要终点
- 2. Subjects who will be having the complete endoscopic healing following 4 weeks of treatment
研究概览
简要总结
Gastroesophagealreflux disease (GERD) is a disease characterized by typical heartburn orseveral symptoms caused by the reflux of gastric acid or food into theesophagus.
Non-erosive refluxdisease (NERD) is characterized by the presence of the typical symptoms of GERDwithout visible erosive esophagitis on endoscopy and erosive esophagitis (EE)is characterized by injury to the esophageal mucosa on endoscopy.
The global pooledprevalence of GERD is 13.98% and varies greatly according to region from a rangeof 12.88% -22.40%.
The prevalence ofGERD in India ranges from 7.6% to 30%, in Russia is 13.3%. According to a studyconducted in Nigeria, a typical African population, the overall prevalence ofGERD was estimated to be 7.6%.
Tegoprazan is abenzimidazole derivative potassium-competitive acid blockers (P-CABs) that wasdeveloped by HK inno.N Corp in Korea; for treatment of GERD and peptic ulcer
The introduction ofthe potassium-competitive acid blockers (P-CABs) has been a significant advancein the pharmacological control of gastric acid secretion.
P-CABs offer a morerapid elevation of intragastric pH than DR-PPIs, while maintaining the samedegree of antisecretory effect. Compared with PPIs, tegoprazan does not needactivation in an acidic environment; therefore, tegoprazan exhibits a fasteronset than PPIs and has highly selective and reversible inhibitory propertiesagainst H+/K+-ATPase in parietal cells.
Compared toconventional PPIs, tegoprazan has a longer half-life and reversible bindingproperties, thus exhibiting a higher inhibition rate for nocturnal acidbreakthrough.
Tegoprazan has the advantage of being less affected by CYP2C19-mediateddrug interactions than PPIs such as omeprazole, esomeprazole, and lansoprazole
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified block randomization
- 盲法
- Double Blind Double Dummy
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects must be able to understand the requirements of the study and be willing to give written informed consent
- •Males and females aged 18-65 years (both inclusive)
- •Subjects Diagnosed with LA Grade A-D erosive esophagitis on an upper gastrointestinal endoscopy within 14 days prior to randomization.
- •Los Angeles (LA) Classification System for erosive esophagitis: Grade Findings A One or more mucosal break, no longer than 5 mm, that does not extend between the tops of 2 mucosal folds B One or more mucosal break, more than 5 mm long, that does not extend between the tops of two mucosal folds C One or more mucosal break, that is continuous between the tops of two or more mucosal folds, but which involve less than 75% of the circumference D One or more mucosal breaks involving 75% or more of the esophageal circumference.
- •Subjects who have experienced both heartburn (burning feeling behind breastbone, pain behind breastbone) and regurgitation for at least 2 days if symptoms are mild or for at least 1 day for moderate to severe symptoms within 7 days prior to visit 1 severity will be defined as mentioned below Point scales for symptom assessment 0 None No symptom 1 Mild There is symptom but no interference with routine activity including sleep 2 Moderate Slight discomfort and interference with routine activity including sleep 3 Severe Symptoms exist for most of the times and interfere with routine activity including sleep frequently.
- •4 Very Severe Symptoms exist consistently and interfere with routine activity including sleep substantially.
- •Females of childbearing potential must have a negative serum pregnancy test at the Screening
- •Consent to use medically appropriate method of birth control or complete abstinence from sexual contacts throughout the study •medically appropriate method of birth control included intrauterine devices, physical barrier (cervical caps with spermicide, diaphragms with spermicide, condoms with spermicides), sustained release injections of birth control, oral contraceptives, tubal ligation, and vasectomy; it is recommended to use dual contraceptive methods in order not to become pregnant during the study.
- •â€¢women under medically sterile condition are allowed to participate in this study as follows; post menopause (amenorrhea for longer than 24 months), hysterectomy, tubectomy and bilateral oophorectomy.
排除标准
- •Patients will not be entered into the study only if they meet any of the following criteria.
- •1.Subjects who are unable to undergo upper GI endoscopy.
- •2.Presence of oesophageal stricture, ulcer stricture, gastroesophageal varices, Barretts oesophagus, active gastric ulcer, gastrointestinal bleeding, or malignant tumour confirmed on an upper GI endoscopy 3.Subjects having symptoms suggestive of malignant gastrointestinal disorder such as odynophagia, severe dysphagia, bleeding, weight loss, anemia, or bloody stool.
- •4.Subjects diagnosed with eosinophilic esophagitis 5.Diagnosed with primary esophageal motility disorder, irritable bowel syndrome (IBS) or inflammatory bowel disease (IBD) within recent 3 months or suspected of IBS.
- •A patient who was suspected of IBS based on physical examination including abdominal discomfort, stool consistency, and frequency by the investigator will be excluded 6.History of gastric acid suppression surgery, oesophageal or gastric surgery except for simple fenestration, appendectomy, cholecystectomy, or endoscopic excision of benign tumour
- •Subjects who have taken PPIs within 2 weeks prior to upper GI endoscopy
- •Having taken two or more commercial doses of reflux esophagitis related medications (including H2 blockers, prostaglandins, mucosal protective agents) within 1 week prior to upper GI endoscopy 9.Requirement of persistent daily use of drugs during the study or treatment within one week of randomization that may cause an ulcer such as nonsteroidal anti-inflammatory drugs (NSAIDs) except for low dose aspirin (≤100 mg/day) taking prior to study participation for prophylactic use persistent use is defined as requirement of chronic use (>12 doses per month) of non-steroidal anti-inflammatory drugs (NSAIDs) including cyclooxygenase-2 (COX-2) NSAIDs within 30 days prior to the Screening Period and throughout the study.
- •Participants who are receiving prohibited medications and are unable to discontinue these drugs for the study duration
- •Pregnant or lactating women
- •Abnormal laboratory results with clinical relevance at screening as follow AST ≥ 2x upper limit of normal (ULN) ALT ≥ 2x ULN ALP ≥ 2x ULN γ-GT≥ 2x ULN Total bilirubin ≥ 2x ULN BUN ≥ 1.5x ULN Creatinine ≥ 1.5x ULN
- •Abnormal ECG of clinical significance including major arrhythmia, multifocal PVC, second degree AV block
- •History or Presence of Zollinger-Ellison syndrome.
- •History of malignancy or any ongoing malignancy at the time of screening 16.Clinically significant hepatic, renal, cardiovascular, respiratory, endocrine or central nervous system (CNS) disorder
- •History of hypersensitivity to the active ingredient or excipients of the study drug including esomeprazole
- •Participation in the other clinical trial within 4 weeks prior to randomization or received any investigational agent prior to randomization within 5 half-lives of the investigational agent as per Investigator discretion.
- •19.The subject has a history of alcohol abuse, illegal drug use, or drug addiction within the 12 months prior to screening, or regularly consumes >21 units of alcohol (1 unit 12 oz/300 mL beer, 1.5 oz/25 mL hard liquor/spirits, or 5 oz/100 mL wine) per week based on self-report.
- •Any clinically significant condition or situation other than the condition being studied that, in the opinion of the investigator, would interfere with the study evaluations or optimal participation in the study.
- •Subjects positive for H.
- •Pylori at screening.
结局指标
主要结局
2. Subjects who will be having the complete endoscopic healing following 4 weeks of treatment
时间窗: 14 days, 28, & 56 days
Evaluation of efficacy of Tegoprazan 50 mg tablet as compared to Esomeprazole 40 mg tablet in patients with erosive gastroesophageal reflux disease.
时间窗: 14 days, 28, & 56 days
1. Mean Cumulative endoscopic healing rate of erosive esophagitis by 8 week based on
时间窗: 14 days, 28, & 56 days
the upper GI endoscopy.
时间窗: 14 days, 28, & 56 days
completion of the study and the result at week 4 will be used as the primary endpoint.
时间窗: 14 days, 28, & 56 days
次要结局
- Evaluation of safety & tolerability of Tegoprazan 50 mg tablet as compared to Esomeprazole 40 mg tablet in patients with erosive gastroesophageal reflux dis-ease.(Healing rate of erosive esophagitis at 4 week based on the upper GI endoscopy following)