Efficacy Study of AGSPT201 Tablet to Treat Gastroesophageal Reflux Disease

Last updated: September 19, 2011
Sponsor: Ahn-Gook Pharmaceuticals Co.,Ltd
Overall Status: Completed

Phase

3

Condition

Gastroesophageal Reflux Disease (Gerd)

Esophageal Disorders

Heartburn (Pediatric)

Treatment

N/A

Clinical Study ID

NCT01400945
AGSPT P3
  • Ages 18-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • aged 18~75 years

  • Patients whose esophageal lesions graded over LA A grade (The severity of lesions isclassified by LA classification)

  • Patients whose typical reflux symptoms such as heartburn, acid regurgitation, acidreflux and esophagus irritation during the past 3 month

  • Symptoms on at least 2 days of the past 7 days

Exclusion

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.

Study Design

Total Participants: 154
Study Start date:
December 01, 2009
Estimated Completion Date:
September 30, 2011

Study 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.

Connect with a study center

  • The Catholic University of Korea St. Mary's Hospital

    Seoul, 137040
    Korea, Republic of

    Site Not Available

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