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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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01499368
First Posted: December 26, 2011
Last Update Posted: January 24, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Boryung Pharmaceutical Co., Ltd
  Purpose
To evaluate the healing rate and safety of Lafutidine in erosive esophagitis

Condition Intervention Phase
Erosive Esophagitis Drug: Lafutidine Drug: Famotidine Drug: Omeprazole Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Boryung Pharmaceutical Co., Ltd:

Primary Outcome Measures:
  • Healing rate of erosive esophagitis [ Time Frame: 8 weeks ]
    Healing rate of erosive esophagitis after 8 weeks based on the baseline


Enrollment: 495
Study Start Date: November 2011
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lafutidine
Lafutidine 20mg/day
Drug: Lafutidine
Lafutidine 20mg/day
Active Comparator: Famotidine
Famotidine 40mg/day
Drug: Famotidine
Famotidine 40mg/day
Omeprazole
Omeprazole 20mg/day
Drug: Omeprazole
Omeprazole 20mg/day

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01499368


Sponsors and Collaborators
Boryung Pharmaceutical Co., Ltd
Investigators
Study Chair: Sang Woo Lee Korea University
  More Information

Responsible Party: Boryung Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier: NCT01499368     History of Changes
Other Study ID Numbers: LAF-BR-CT-302
First Submitted: December 21, 2011
First Posted: December 26, 2011
Last Update Posted: January 24, 2013
Last Verified: January 2013

Additional relevant MeSH terms:
Esophagitis
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Omeprazole
Famotidine
Lafutidine
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Histamine H2 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Physiological Effects of Drugs