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临床试验/CTRI/2023/11/059403
CTRI/2023/11/059403已完成3 期

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 - NI

Dr. Reddy’s Laboratories Ltd.0 个研究点目标入组 0 人开始时间: 待定最近更新:
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试验速览

阶段
3 期
状态
已完成
发起方
研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

入选标准

  • •1. Subjects must be able to understand the requirements of the study and be willing to give written informed consent
  • •2. Males and females aged 18-65 years (both inclusive)
  • •3. 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.
  • •4. 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.
  • •5. Females of childbearing potential must have a negative serum pregnancy test at the Screening
  • •6. 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.
  • •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
  • •7. Subjects who have taken PPIs within 2 weeks prior to upper GI endoscopy
  • •8. 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.
  • •10. Participants who are receiving prohibited medications and are unable to discontinue these drugs for the study duration
  • •11. Pregnant or lactating women
  • •12. Abnormal laboratory results with clinical relevance at screening as follow
  • •AST = 2x upper limit of normal (ULN)
  • •ALT = 2x ULN
  • •ALP = 2x ULN
  • •?-GT= 2x ULN
  • •Total bilirubin = 2x ULN
  • •BUN = 1.5x ULN
  • •Creatinine = 1.5x ULN
  • •13. Abnormal ECG of clinical significance including major arrhythmia, multifocal PVC, second degree AV block
  • •14. History or Presence of Zollinger-Ellison syndrome.
  • •15. 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
  • •17. History of hypersensitivity to the active ingredient or excipients of the study drug including esomeprazole
  • •18. 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.
  • •20. Any clin

研究者

发起方
Dr. Reddy’s Laboratories Ltd.

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