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Completed

NCT Number: NCT01499368

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

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

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Key information

Conditions

Erosive Esophagitis

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lafutidine

Drug

Lafutidine 20mg/day

Famotidine

Drug

Famotidine 40mg/day

Omeprazole

Drug

Omeprazole 20mg/day

Primary outcomes

  1. Recovery Rates of Reflux Esophagitis

    Time frame: 8 weeks

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

Secondary outcomes

  1. The Proportion of Days Without 'Cardinal Symptom'

    Time frame: 4 or 8 week

    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

  2. The Proportion of Daytimes Without 'Cardinal Symptom'

    Time frame: 4 or 8 week

    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

  3. The Proportion of Nighttimes Without 'Cardinal Symptom'

    Time frame: 4 or 8 week

    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

Sponsors and collaborators

Lead sponsor

Boryung Pharmaceutical Co., Ltd

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Dec 26, 2011
Registry last updated
Jan 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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