Text Size

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:
Information provided by (Responsible Party):
Boryung Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier:
NCT01499368
First received: December 21, 2011
Last updated: January 23, 2013
Last verified: January 2013
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Healing rate of erosive esophagitis [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01499368

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

No publications provided

Responsible Party: Boryung Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier: NCT01499368     History of Changes
Other Study ID Numbers: LAF-BR-CT-302
Study First Received: December 21, 2011
Last Updated: January 23, 2013
Health Authority: Korea: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 19, 2013