Study to Evaluate the Efficacy and Safety of Tegoprazan in ERD Patients With Nighttime Heartburn and Sleep Disturbance
- Registration Number
- NCT04309916
- Lead Sponsor
- HK inno.N Corporation
- Brief Summary
This study aims to compare the nighttime heartburn and sleep disturbance improvement effect of Tegoprazan 50mg and Eomeprazole 40mg in patients with ERD patients.
- Detailed Description
This is a multi-center, double-blind, randomized, active-controlled phase 4 (pilot) study. Subjects will be randomly assigned to one of the two treatment groups (tegoprazan 50mg, esomeprazole 40mg)
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 46
Inclusion Criteria
- Subjects aged between 19 and 75 years
- Subjects who have erosive reflux disease
Exclusion Criteria
- Unable to undergo upper GI endoscopy
- Symptoms of primary or secondary esophageal movement disorders
- Planning or Perform surgery that can affect gastric acid secretion (e.g., upper gastrectomy, Vagotomy, etc.)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Esomeprazole 40mg Esomeprazole Esomeprazole 40mg tablet, once daily, oral administration Tegoprazan 50mg Tegoprazan Tegoprazan 50mg tablet, once daily, oral administration
- Primary Outcome Measures
Name Time Method Time to first nighttime heartburn-free interval (days)) 2 week Number of days to reach the without symptoms of nighttime heartburn after the start of drug administration for clinical trials.
- Secondary Outcome Measures
Name Time Method Percentage of days without nighttime heartburn during the 2-week dosing period 2 week Percentage of days without nighttime heartburn = Number of days without nighttime heartburn symptoms during the dosing period / Number of days when nighttime heartburn was assessed x 100
Trial Locations
- Locations (1)
Severance Hospital
🇰🇷Seoul, Korea, Republic of