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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

Primary Purpose

Erosive Esophagitis

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Lafutidine
Famotidine
Omeprazole
Sponsored by
Boryung Pharmaceutical Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Erosive Esophagitis

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Active Comparator

    Other

    Arm Label

    Lafutidine

    Famotidine

    Omeprazole

    Arm Description

    Lafutidine 20mg/day

    Famotidine 40mg/day

    Omeprazole 20mg/day

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    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
    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
    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

    Full Information

    First Posted
    December 21, 2011
    Last Updated
    August 28, 2020
    Sponsor
    Boryung Pharmaceutical Co., Ltd
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01499368
    Brief 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 Korean Erosive Esophagitis Patients
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2011 (undefined)
    Primary Completion Date
    November 2012 (Actual)
    Study Completion Date
    November 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Boryung Pharmaceutical Co., Ltd

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Erosive Esophagitis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    495 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Lafutidine
    Arm Type
    Experimental
    Arm Description
    Lafutidine 20mg/day
    Arm Title
    Famotidine
    Arm Type
    Active Comparator
    Arm Description
    Famotidine 40mg/day
    Arm Title
    Omeprazole
    Arm Type
    Other
    Arm Description
    Omeprazole 20mg/day
    Intervention Type
    Drug
    Intervention Name(s)
    Lafutidine
    Intervention Description
    Lafutidine 20mg/day
    Intervention Type
    Drug
    Intervention Name(s)
    Famotidine
    Intervention Description
    Famotidine 40mg/day
    Intervention Type
    Drug
    Intervention Name(s)
    Omeprazole
    Intervention Description
    Omeprazole 20mg/day
    Primary Outcome Measure Information:
    Title
    Recovery Rates of Reflux Esophagitis
    Description
    Recovery rates of reflux esophagitis on the Esophago Gastro Duodenoscopy test after 8 week treatment-FAS
    Time Frame
    8 weeks
    Secondary Outcome Measure Information:
    Title
    The Proportion of Days Without 'Cardinal Symptom'
    Description
    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
    Time Frame
    4 or 8 week
    Title
    The Proportion of Daytimes Without 'Cardinal Symptom'
    Description
    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
    Time Frame
    4 or 8 week
    Title
    The Proportion of Nighttimes Without 'Cardinal Symptom'
    Description
    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
    Time Frame
    4 or 8 week

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Sang Woo Lee
    Organizational Affiliation
    Korea University
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this 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

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