Short-term efficacy of tegoprazan in patients with non-erosive reflux disease with nocturnal heartburn symptom
- Conditions
- Diseases of the digestive system
- Registration Number
- KCT0004833
- Lead Sponsor
- Inje University Haeundae Paik Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 160
1) Only adult men and women over 19 years old
2) Those who have complained of heartburn at least 6 months prior to Visit 1
3) No mucosal break was observed according to LA classification in the upper gastrointestinal endoscopy performed by the institution within 28 days before the start of investigational drug administration.
4) Those who have a GERD-Q questionnaire score of 8 or higher in the screening test
5) Those who complain of nighttime heartburn more than 3 times a week
1) Those who cannot receive an upper gastrointestinal endoscopy
2) Upper gastrointestinal endoscopy shows esophageal stricture, gastrointestinal varices, Barrett's esophagus, active peptic ucler, GI bleeding, or eosinophilic esophagitis
3) Those who received surgery on esophagus, stomach or duodenum
4) Those who have hypersensitivity reactions to medicines for clinical trials
5) Pregnant women, lactating women
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of days without nocturnal heartburn symptom
- Secondary Outcome Measures
Name Time Method Percentage of subjects whose nocturnal heartburn symptoms are subsided