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NCT01499368 Clinical Trial

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

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01499368
Other study ID # LAF-BR-CT-302
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date November 2011
Est. completion date November 2012

Study information
Verified date August 2020
Source Boryung Pharmaceutical Co., Ltd
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Lafutidine
Lafutidine 20mg/day
• Famotidine
Famotidine 40mg/day
• Omeprazole
Omeprazole 20mg/day

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Boryung Pharmaceutical Co., Ltd

Outcome
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
See also
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Completed NCT00206180 - NEXIUM® in the Treatment of Moderate and Severe Erosive Esophagitis Phase 4
Completed NCT01630746 - A Randomized, Double-Blind, Multicenter Study to Evaluate the Acid-inhibitory and Dose-response Efficacy of TAK-438 (20 mg, 40 mg) in Patients With Proton Pump Inhibitor (PPI) - Resistant Erosive Esophagitis Phase 3
Completed NCT01642615 - Safety and Efficacy of Dexlansoprazole Delayed-Release Capsules for Healing of Erosive Esophagitis and Maintenance of Healed Erosive Esophagitis and Relief of Heartburn in Adolescents Phase 2
Completed NCT01509261 - Efficacy Study of Ilaprazole to Treat Erosive Esophgitis Phase 3