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

April 26, 2016 updated by: YongChan Lee

A Multicenter, Randomized, Double-blinded, Placebo-controlled Pilot Study to Evaluate the Efficacy and Safety of Rebamipide as an Adjuvant Regimen to Heal erosIve Reflux Esophagitis (REPAIR)

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

  1. To evaluate whether Rebamipide facilitate the healing of inflamed mucosa as an adjuvant regimen in erosive reflux esophagitis patients
  2. To evaluate the safety of rebamipide as an adjuvant regimen in erosive reflux esophagitis (ERE)

Study Type

Interventional

Enrollment (Actual)

143

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Chongqing
      • Chongqing, Chongqing, China, 400037
        • Yang Shiming
  • Korea, Republic of
      • Bucheon, Korea, Republic of
        • Soonchunhyang University Bucheon Hospital
      • Daegu, Korea, Republic of
        • Kyungpook National University Medical Center
      • Daejeon, Korea, Republic of
        • Konyang University Hospital
      • Seoul, Korea, Republic of
        • Severance Hospital, Yonsei University Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Male/female patients aged 20 to 70 at the time of writing an informed consent.
  2. Subjects who were diagnosed with Erosive Reflux Esophagitis (ERE) using Los Angeles (LA) classification grade A~D, confirmed by endoscopy.

  3. The subjects regardless of presence of ERE symptom (i.e., symptomatic ERE or asymptomatic ERE).

    For symptomatic ERE, the subject must have one or more symptoms of the followings: acid regurgitation, heartburn, epigastric pain, cough, hoarseness, globus pharyngis, atypical chest pain.

  4. Subjects who have consented to participate in this clinical study by signing an informed consent form.

Exclusion Criteria:

  1. Patients with known hypersensitivity to any component of Lanston® and/or Mucosta® formulations.
  2. Other concurrent organic upper gastroesophageal disease in endoscopy (i.e., drug-induced esophagitis, viral esophagitis, Mallory-Weiss syndrome, peptic ulcer disease, malignancies) and patients who was diagnosed with Barrett's esophagus.
  3. History of abdominal surgery that can affect gastrointestinal motility (except appendectomy and hysterectomy).
  4. History of upper gastrointestinal bleeding or obstruction.
  5. Patients administrated with any drugs that can affect the efficacy of study regimen (proton pump inhibitors, revaprazan, prokinetics, H2-blockers, etc.) within 2 weeks (however, 4 weeks for PPIs) prior to enrollment and/or those who are required of NSAIDs, anti-coagulants, anti-cholinergics, prostaglandin E, corticosteroids, and anti-depressants treatment during the study period.
  6. History of pancreatobiliary disease (except asymptomatic gallbladder stone), inflammatory bowel disease, cirrhotic liver disease, chronic kidney disease.
  7. Pregnant, nursing, and childbearing potential women who is unwilling to effective contraception; for example, oral contraceptives, hormonal methods, placement of an intrauterine device (IUD) or intrauterine system (IUS), barrier methods (i.e., condom or occlusive cap with spermicidal foam/gel/film/cream/suppository), male sterilization, and true abstinence.
  8. History of psychological disorder, alcoholics, and drug abuser.
  9. Blood test results of hemoglobin (Hb) ≤ 10.0 g/dL, platelets ≤ 50,000 /µL, total WBCs ≤ 4,000/µL or ≥ 10,000/µL, and with serum test results showing the levels of AST, ALT, ALP, BUN, and creatinine exceeding twice the normal range of respective institution.
  10. Patients who previously underwent another clinical survey within 4 weeks.
  11. History of major medical disease that can affect general condition and other patients deemed not eligible for this study by investigators.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study Group
  1. Lanston® (lansoprazole) 30 mg, 1 capsule, PO, qd, 30 min before breakfast
  2. Mucosta® (rebamipide) 100 mg, 1 tablet, PO, tid, 30 minutes before breakfast, lunch and dinner
Drug: Lansoprazole
Oral administration of Lanston® (lansoprazole) 30 mg, 1 capsule, PO, qd, 30 min before breakfast
Other Names:
  • Lanston
Drug: Rebamipide
Oral administration of Mucosta (rebamipide) 100 mg, 1 tablet, PO, tid, 30 minutes before breakfast, lunch, and dinner
Other Names:
  • Mucosta
Placebo Comparator: Control Group
  1. Lanston® (lansoprazole) 30 mg, 1 capsule, PO, qd, 30 min before breakfast
  2. Mucosta®-placebo (rebamipide-placebo), 1 tablet, PO, tid, 30 minutes before breakfast, lunch and dinner
Drug: Lansoprazole
Oral administration of Lanston® (lansoprazole) 30 mg, 1 capsule, PO, qd, 30 min before breakfast
Other Names:
  • Lanston
Drug: Rebamipide-placebo
Oral administration of Mucosta®-placebo, 1 tablet, PO, tid, 30 minutes before breakfast, lunch and dinner
Other Names:
  • Mucosta-placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Endoscopic healing rate
Time Frame: 4 weeks
The ratio of the endoscopically completely healed (normal or minimal change) patients per groups
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Histologic change
Time Frame: 4 weeks
Histologic change defined with Hematoxylin and eosin (H&E) stain
4 weeks
Change in inflammatory cytokines
Time Frame: 4 weeks
Change in the tissue level of Platelet activating factor (PAF) and Interleukin-8 (IL-8)
4 weeks
Time to complete symptom relief
Time Frame: every 2 week, up to 4 week
Interval between inital medication and the first time of symptom relief judged by subject's diary
every 2 week, up to 4 week
Overall symptom relief
Time Frame: every 2 week, up to 4 week
The proportion of relieved subjects at the end of treatment
every 2 week, up to 4 week
Adverse events profile
Time Frame: every 2 week, up to 4week
patient's symptoms, physical findings, abnormal laboratory values, vital signs, and ECG findings
every 2 week, up to 4week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

YongChan Lee

Collaborators

Otsuka Pharmaceutical Co., Ltd.

Investigators

  • Principal Investigator: Yong Chan Lee, MD, PhD, Severance Hospital, Yonsei University Health System
  • Principal Investigator: Seong Woo Jeon, MD, PhD, Kyungpook National University Medical Center
  • Principal Investigator: Su Jin Hong, MD, PhD, Soonchunhyang University Buchen Hospital
  • Principal Investigator: Kyung Ho Song, MD, Master, Konyang University Hospital
  • Principal Investigator: Shiming Yang, MD, PhD, Xinqiao Hospital of Chongqing

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

September 2, 2015

First Submitted That Met QC Criteria

April 26, 2016

First Posted (Estimate)

April 29, 2016

Study Record Updates

Last Update Posted (Estimate)

April 29, 2016

Last Update Submitted That Met QC Criteria

April 26, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 037-OTC-1201i

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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