Status:

COMPLETED

A Multi-center, Randomized, Double-blind Phase III Clinical Trial to Assess and Compare to the Efficacy and Safety of Lafutidine, Famotidine and Omeprazole-referenced in Korean Erosive Esophagitis Patients

Lead Sponsor:

Boryung Pharmaceutical Co., Ltd

Conditions:

Erosive Esophagitis

Eligibility:

All Genders

20-75 years

Phase:

PHASE3

Brief Summary

To evaluate the healing rate and safety of Lafutidine in erosive esophagitis

Eligibility Criteria

Inclusion

  • Patients who had symptoms of heartburn with a diagnosis of grade A to D reflux esophagitis according to the Los Angeles classification

Exclusion

  • Gastric or duodenal ulcers (excluding ulcer scars)
  • Concurrent presence of Barrett's esophagus
  • A history of a poor response to H2RA or PPI given in the recommended dose for 8 weeks
  • Other conditions considered by the attending physician to potentially affect the assessment of efficacy and safety

Key Trial Info

Start Date :

November 1 2011

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

November 1 2012

Estimated Enrollment :

495 Patients enrolled

Trial Details

Trial ID

NCT01499368

Start Date

November 1 2011

End Date

November 1 2012

Last Update

January 15 2025

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A Multi-center, Randomized, Double-blind Phase III Clinical Trial to Assess and Compare to the Efficacy and Safety of Lafutidine, Famotidine and Omeprazole-referenced in Korean Erosive Esophagitis Patients | DecenTrialz