Efficacy Study of AGSPT201 Tablet to Treat Gastroesophageal Reflux Disease

Ahn-Gook Pharmaceuticals Co.,Ltd154 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

154

Conditions

Gastroesophageal Reflux Disease

Interventions

AGSPT201 Tab contains S-pantoprazoleDRUG

comparison of Pantoloc Tab 40mg

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (1)

The Catholic University of Korea St. Mary's Hospital

Seoul, Seoul, South Korea

Outcomes

Primary Outcomes

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.

Time frame: 4 week

Secondary Outcomes

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).

Time frame: 4 week

Data from ClinicalTrials.gov

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