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 3CompletedNCT01499368

Boryung Pharmaceutical Co., Ltd495 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

495

Conditions

Erosive Esophagitis

Interventions

LafutidineDRUG

Lafutidine 20mg/day

FamotidineDRUG

Famotidine 40mg/day

OmeprazoleDRUG

Omeprazole 20mg/day

Eligibility

Sex: ALLMin age: 20 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Recovery Rates of Reflux Esophagitis

Recovery rates of reflux esophagitis on the Esophago Gastro Duodenoscopy test after 8 week treatment-FAS

Time frame: 8 weeks

Secondary Outcomes

The Proportion of Days Without 'Cardinal Symptom'

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

Time frame: 4 or 8 week

The Proportion of Daytimes Without 'Cardinal Symptom'

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

Time frame: 4 or 8 week

The Proportion of Nighttimes Without 'Cardinal Symptom'

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

Time frame: 4 or 8 week

Data from ClinicalTrials.gov

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