Efficacy Study of AGSPT201 Tablet to Treat Gastroesophageal Reflux Disease

Ahn-Gook Pharmaceuticals

Status and phase

Completed

Phase 3

Conditions

Gastroesophageal Reflux Disease

Treatments

Drug: AGSPT201 Tab contains S-pantoprazole

Study type

Interventional

Funder types

Industry

Identifiers

NCT01400945

AGSPT P3

Details and patient eligibility

About

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.

Full 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.

Enrollment

154 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.