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

Phase 3

Completed

• Conditions: Erosive Esophagitis
• Interventions: Drug: Omeprazole; Drug: Lafutidine; Drug: Famotidine

• Registration Number: NCT01499368
• Lead Sponsor: Boryung Pharmaceutical Co., Ltd

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2011-12-21
• Study First Submitted QC: 2011-12-22
• Study First Posted: 2011-12-26
• Primary Completion: 2012-11
• Study Completion: 2012-11
• Results First Submitted: 2018-01-16
• Results First Submitted QC: 2020-08-28
• Results First Posted: 2020-09-16
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-06
• Last Update Posted: 2025-01-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 495

Inclusion Criteria

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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Omeprazole	Omeprazole	Omeprazole 20mg/day
Lafutidine	Lafutidine	Lafutidine 20mg/day
Famotidine	Famotidine	Famotidine 40mg/day

Primary Outcome Measures

Name	Time	Method
Recovery Rates of Reflux Esophagitis	8 weeks	Recovery rates of reflux esophagitis on the Esophago Gastro Duodenoscopy test after 8 week treatment-FAS

Secondary Outcome Measures

Name	Time	Method
The Proportion of Nighttimes Without 'Cardinal Symptom'	4 or 8 week	The proportion of Nighttimes without 'Cardinal symptom' after 4 or 8 treatment-FAS 'Cardinal symptom': Burning sensation in the chest, Acid reflux, Heartburn including chest pain
The Proportion of Days Without 'Cardinal Symptom'	4 or 8 week	The proportion of days without 'Cardinal symptom' after 4 or 8 week treatment-FAS 'Cardinal symptom': Burning sesation in the chest, Acid reflux, Heartburn including chest pain
The Proportion of Daytimes Without 'Cardinal Symptom'	4 or 8 week	The proportion of daytimes without 'Cardinal symptom' after 4 or 8 week treatment-FAS 'Cardinal symptom': Burning sensation in the chest, Acid reflux, Heartburn including chest pain