A Clinical Trial to Assess the effect of Tegoprazan in patients with Erosive Gastroesophageal Reflux Disease
- Conditions
- Health Condition 1: K210- Gastro-esophageal reflux disease with esophagitis
- Registration Number
- CTRI/2023/11/059403
- Lead Sponsor
- Dr. Reddy’s Laboratories Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 0
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.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Evaluation of efficacy of Tegoprazan 50 mg tablet as compared to Esomeprazole 40 mg tablet in patients with erosive gastroesophageal reflux disease. <br/ ><br> <br/ ><br>1. Mean Cumulative endoscopic healing rate of erosive esophagitis by 8 week based on <br/ ><br>the upper GI endoscopy. <br/ ><br> <br/ ><br>2. Subjects who will be having the complete endoscopic healing following 4 weeks of treatment <br/ ><br>completion of the study and the result at week 4 will be used as the primary endpoint. <br/ ><br>Timepoint: 14 days, 28, & 56 days
- Secondary Outcome Measures
Name Time Method Evaluation of safety & tolerability of Tegoprazan 50 mg tablet as compared to Esomeprazole 40 mg tablet in patients with erosive gastroesophageal reflux dis-ease. <br/ ><br> <br/ ><br>Healing rate of erosive esophagitis at 4 week based on the upper GI endoscopy following <br/ ><br>2. weeks of study treatment. <br/ ><br>3. Mean change in GERD-HRQL (GERD-Health related quality life) score from baseline <br/ ><br>4.to week 2, 4 & 8. <br/ ><br>5.Symptom assessment based on subject diary at 1, 2, 4 & 8 weeks <br/ ><br>Timepoint: 14 days, 28, & 56 days