Efficacy Study of AGSPT201 Tablet to Treat Gastroesophageal Reflux Disease

Study Overview
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Brief Summary
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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
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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.

Official Title
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Double Blinded, Randomized, Active Drug Comparative, Therapeutic Confirmatory Clinical Study to Evaluate the Efficacy and Safety of AGSPT201 in GERD Patients

Conditions
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Gastroesophageal Reflux Disease

Intervention / Treatment
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* Drug: AGSPT201 Tab contains S-pantoprazole


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: S-Pantoprazole<br>Experimental drug: AGSPT201 Tab. (contain S-Patoprazole) Active comparator: Pantoloc Tab. (contain pantoprazole) | Drug: AGSPT201 Tab contains S-pantoprazole<br>* comparison of Pantoloc Tab 40mg<br>* Other names: AGSPT201 Tab. (Brand name Deflux tab);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with healing of erosive esophagitis(The absence of esophageal lesions) | 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. | 4 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absence and/or improvement of typical reflux symptoms | 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). | 4 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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GERD, endoscopy, LA grade, heartburn