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

NCT01499368 | Completed Phase 3 Results DMC

• 1 other identifier: LAF-BR-CT-302
• Study Type: interventional
• Target: 495
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Erosive Esophagitis

Outcome Measures

Primary Outcomes (1)

• Recovery Rates of Reflux Esophagitis

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

  8 weeks

Secondary Outcomes (3)

• The Proportion of Days Without 'Cardinal Symptom'

  4 or 8 week

• The Proportion of Daytimes Without 'Cardinal Symptom'

  4 or 8 week

• The Proportion of Nighttimes Without 'Cardinal Symptom'

  4 or 8 week

Study Arms (3)

Lafutidine

EXPERIMENTAL

Lafutidine 20mg/day

Drug: Lafutidine

Famotidine

ACTIVE COMPARATOR

Famotidine 40mg/day

Drug: Famotidine

Omeprazole

OTHER

Omeprazole 20mg/day

Drug: Omeprazole

Interventions

Lafutidine DRUG

Lafutidine 20mg/day

Lafutidine

Famotidine DRUG

Famotidine 40mg/day

Famotidine

Omeprazole DRUG

Omeprazole 20mg/day

Omeprazole

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boryung Pharmaceutical Co., Ltd: lead

MeSH Terms

Interventions

lafutidine; Famotidine; Omeprazole

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Pyridines; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Manager of Clinical Research
• Organization: Boryung Pharmaceuticals

rainbowleo@boryung.co.kr

+82-2-708-8069

Study Officials

• Sang Woo Lee

  Korea University Ansan Hospital

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2011
• First Posted: December 26, 2011
• Study Start: November 1, 2011
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: January 15, 2025
• Results First Posted: September 16, 2020

Record last verified: 2025-01