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A Study to Evaluate REbamiPide as an Adjuvant Regimen to Heal erosIve Reflux Esophagitis

NCT02755753 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 143

Last updated 2016-04-29

No results posted yet for this study

Summary

The purpose of this study is to evaluate whether Rebamipide facilitate the healing of inflamed mucosa as an adjuvant regimen in erosive reflux esophagitis (ERE).

Conditions

  • Gastroesophageal Reflux

Interventions

DRUG

Lansoprazole

Oral administration of Lanston® (lansoprazole) 30 mg, 1 capsule, PO, qd, 30 min before breakfast

DRUG

Rebamipide

Oral administration of Mucosta (rebamipide) 100 mg, 1 tablet, PO, tid, 30 minutes before breakfast, lunch, and dinner

DRUG

Rebamipide-placebo

Oral administration of Mucosta®-placebo, 1 tablet, PO, tid, 30 minutes before breakfast, lunch and dinner

Sponsors & Collaborators

  • Otsuka Pharmaceutical Co., Ltd.

    collaborator INDUSTRY

  • YongChan Lee

    lead OTHER

Principal Investigators

  • Yong Chan Lee, MD, PhD · Severance Hospital, Yonsei University Health System

  • Seong Woo Jeon, MD, PhD · Kyungpook National University Medical Center

  • Su Jin Hong, MD, PhD · Soonchunhyang University Buchen Hospital

  • Kyung Ho Song, MD, Master · Konyang University Hospital

  • Shiming Yang, MD, PhD · Xinqiao Hospital of Chongqing

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2016-01-31
Completion
2016-04-30

Countries

  • China
  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02755753 on ClinicalTrials.gov