Gastroesophageal Reflux Disease
Conditions
Keywords
GERD, endoscopy, LA grade, heartburn
Brief summary
The purpose of this study is to evaluate treatment in Gastroesophageal Reflux Disease (GERD) patients (aged 18\ 75) with endoscopically proven GERD treated with AGSPT201 Tablet.
Detailed description
This study is 4,8 weeks, outpatient, multicenter, randomized, double-blinded, active drug comparative, therapeutic confirmatory clinical study to evaluate the efficacy and safety of AGSPT201 in erosive esophagitis patients.
Interventions
DRUGAGSPT201 Tab contains S-pantoprazole
comparison of Pantoloc Tab 40mg
Sponsors
Ahn-Gook Pharmaceuticals Co.,Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* aged 18\ 75 years * Patients whose esophageal lesions graded over LA A grade (The severity of lesions is classified by LA classification) * Patients whose typical reflux symptoms such as heartburn, acid regurgitation, acid reflux and esophagus irritation during the past 3 month * Symptoms on at least 2 days of the past 7 days
Exclusion criteria
* PPI treatment within 4 weeks before dosing or treatment of H2 blocker, sucralfate, prokinase NSAID (except low dose aspirin) within 2 weeks before dosing. * Patients whose history of GI tract resection or vagotomy. * Barrett's oesophagus greater than 3cm in length and high-grade dysplasia. * Acid irrelevant Heartburn and regurgitation. * Zollinger Ellison syndrome * Hypersensitive and/or allergy to Pantoprazole and/or other PPI * Pregnancy and lactation * peptic ulcer * serious hepatic * any other renal, cardiac or haematological disease. * Patients participated any other clinical studies during the past 3 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with healing of erosive esophagitis(The absence of esophageal lesions) | 4 week | Endoscopy is performed at baseline and 4 week. All patients whose esophageal lesions are graded (LA Grade A, B, C and D). The study is completed for the patients whose esophageal lesions are healed. However patients whose esophageal lesions are not healed at 4 week were treated for an additional 4 week with endoscopy repeated at 8 week. At 8 week, the study is completed regardless healing of esophageal lesions. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Absence and/or improvement of typical reflux symptoms | 4 week | Patients recorded the improvement of typical reflux symptoms such as heartburn, acid regurgitation, acid reflux and esophagus irritation on diary card. The presence of symptoms are classified to absence (Score 0), mild (Score 1), moderate (Score 2), severe (Score 3) and very severe (Score 4). |
Countries
South Korea
Outcome results
None listed