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

NCT ID: NCT01499368

Last Updated: 2025-01-15

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

495 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2012-11-30

Brief Summary

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

Detailed Description

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Conditions

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Erosive Esophagitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Lafutidine

Lafutidine 20mg/day

Group Type EXPERIMENTAL

Lafutidine

Intervention Type DRUG

Lafutidine 20mg/day

Famotidine

Famotidine 40mg/day

Group Type ACTIVE_COMPARATOR

Famotidine

Intervention Type DRUG

Famotidine 40mg/day

Omeprazole

Omeprazole 20mg/day

Group Type OTHER

Omeprazole

Intervention Type DRUG

Omeprazole 20mg/day

Interventions

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Lafutidine

Lafutidine 20mg/day

Intervention Type DRUG

Famotidine

Famotidine 40mg/day

Intervention Type DRUG

Omeprazole

Omeprazole 20mg/day

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boryung Pharmaceutical Co., Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sang Woo Lee

Role: STUDY_CHAIR

Korea University Ansan Hospital

Other Identifiers

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LAF-BR-CT-302

Identifier Type: -

Identifier Source: org_study_id

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