Erosive Esophagitis Clinical Trial
Official title:
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 Koran Erosive Esophagitis Patients
Verified date | August 2020 |
Source | Boryung Pharmaceutical Co., Ltd |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To evaluate the healing rate and safety of Lafutidine in erosive esophagitis
Status | Completed |
Enrollment | 495 |
Est. completion date | November 2012 |
Est. primary completion date | November 2012 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 75 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Boryung Pharmaceutical Co., Ltd |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Recovery Rates of Reflux Esophagitis | Recovery rates of reflux esophagitis on the Esophago Gastro Duodenoscopy test after 8 week treatment-FAS | 8 weeks | |
Secondary | 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 | 4 or 8 week | |
Secondary | 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 | 4 or 8 week | |
Secondary | 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 | 4 or 8 week |
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