Comparison of esomeprazole and fexuprazan in gastroesophageal reflux disease
- Conditions
- Diseases of the digestive system
- Registration Number
- KCT0008531
- Lead Sponsor
- Dongguk University Ilsan Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 40
1) Adults between the ages of 19 and 80
2) Patients with erosive reflux esophagitis confirmed by gastroscopy
3) Patients who have repeatedly had nocturnal acid secretion symptoms within the previous 3 months
4) Patients who have improved symptoms with PPI or gastric acid secretion inhibitor
5) Those who can understand and follow instructions and participate in the clinical trial
1) Those with swallowing disorder or diagnosed with esophageal motility disease
2) Those who have been diagnosed with peptic ulcer and gastric cancer by gastroscopy within 3 months
3) Patients with gastroesophageal reflux disease who are refractory to PPI treatment
4) Patients who have undergone previous total gastrectomy
5) Patients who have participated in other clinical trials within 30 days from the date of screening and are taking investigational drugs
6) Those who fall under the contraindications in the precautions for use of investigational drugs
7) Patients who are pregnant or plan to become pregnant
8) Others judged by the researcher to be unfit to participate in this test
Study & Design
- Study Type
- Observational Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1) Intensity of nighttime acid secretion symptoms (heart-burn, epigastric soreness, acid regurgitation, etc.) [VAS score (0-10)] 2) Frequency of nocturnal gastric acid secretion symptoms 3) Frequency of awakening from sleep due to symptoms of nocturnal gastric acid secretion
- Secondary Outcome Measures
Name Time Method Adverse reactions and safety 1) Collect all symptoms such as headache, dizziness, upper abdominal discomfort and hospital visit records 2) Check the association between this adverse reaction and fexuprazan and omeprazole