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

Boryung

Status and phase: Completed; Phase 3

Conditions: Erosive Esophagitis

Treatments: Drug: Famotidine; Drug: Lafutidine; Drug: Omeprazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT01499368

LAF-BR-CT-302

Details and patient eligibility

About

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

Enrollment: 495 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

495 participants in 3 patient groups

Lafutidine

Experimental group

Description:

Lafutidine 20mg/day

Treatment:

Drug: Lafutidine

Famotidine

Active Comparator group

Description:

Famotidine 40mg/day

Treatment:

Drug: Famotidine

Omeprazole

Other group

Description:

Omeprazole 20mg/day

Treatment:

Drug: Omeprazole