Double Blinded, Randomized, Active Drug Comparative, Therapeutic Confirmatory Clinical Study to Evaluate the Efficacy and Safety of AGSPT201 in GERD Patients
Overview
- Phase
- Phase 3
- Intervention
- AGSPT201 Tab contains S-pantoprazole
- Conditions
- Gastroesophageal Reflux Disease
- Sponsor
- Ahn-Gook Pharmaceuticals Co.,Ltd
- Enrollment
- 154
- Locations
- 1
- Primary Endpoint
- Number of patients with healing of erosive esophagitis(The absence of esophageal lesions)
- Status
- Completed
- Last Updated
- 14 years ago
Overview
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.
Investigators
Eligibility Criteria
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.
Arms & Interventions
S-Pantoprazole
Experimental drug: AGSPT201 Tab. (contain S-Patoprazole) Active comparator: Pantoloc Tab. (contain pantoprazole)
Intervention: AGSPT201 Tab contains S-pantoprazole
Outcomes
Primary Outcomes
Number of patients with healing of erosive esophagitis(The absence of esophageal lesions)
Time Frame: 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 Outcomes
- Absence and/or improvement of typical reflux symptoms(4 week)