Status:
COMPLETED
Efficacy Study of AGSPT201 Tablet to Treat Gastroesophageal Reflux Disease
Lead Sponsor:
Ahn-Gook Pharmaceuticals Co.,Ltd
Conditions:
Gastroesophageal Reflux Disease
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
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 erosiv...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
154 Patients enrolled
Trial Details
Trial ID
NCT01400945
Start Date
December 1 2009
End Date
September 1 2011
Last Update
September 21 2011
Active Locations (1)
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1
The Catholic University of Korea St. Mary's Hospital
Seoul, Seoul, South Korea, 137040