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

Sponsor
YongChan Lee (Other)
Overall Status
Completed
CT.gov ID
NCT02755753
Collaborator
Otsuka Pharmaceutical Co., Ltd. (Industry)
143
Enrollment
5
Locations
2
Arms
27
Duration (Months)
28.6
Patients Per Site
1.1
Patients Per Site Per Month

Study Details

Study Description

Brief 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).

Condition or Disease Intervention/Treatment Phase
Phase 4

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 Design

Study Type:
Interventional
Actual Enrollment :
143 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
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)
Study Start Date :
Jan 1, 2014
Actual Primary Completion Date :
Jan 1, 2016
Actual Study Completion Date :
Apr 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: Study Group

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

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Endoscopic healing rate [4 weeks]

      The ratio of the endoscopically completely healed (normal or minimal change) patients per groups

    Secondary Outcome Measures

    1. Histologic change [4 weeks]

      Histologic change defined with Hematoxylin and eosin (H&E) stain

    2. Change in inflammatory cytokines [4 weeks]

      Change in the tissue level of Platelet activating factor (PAF) and Interleukin-8 (IL-8)

    3. Time to complete symptom relief [every 2 week, up to 4 week]

      Interval between inital medication and the first time of symptom relief judged by subject's diary

    4. Overall symptom relief [every 2 week, up to 4 week]

      The proportion of relieved subjects at the end of treatment

    5. Adverse events profile [every 2 week, up to 4week]

      patient's symptoms, physical findings, abnormal laboratory values, vital signs, and ECG findings

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    1. 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Yang Shiming Chongqing Chongqing China 400037
    2 Soonchunhyang University Bucheon Hospital Bucheon Korea, Republic of
    3 Kyungpook National University Medical Center Daegu Korea, Republic of
    4 Konyang University Hospital Daejeon Korea, Republic of
    5 Severance Hospital, Yonsei University Health System Seoul Korea, Republic of

    Sponsors and Collaborators

    • YongChan Lee
    • 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    YongChan Lee, Professor, Severance Hospital
    ClinicalTrials.gov Identifier:
    NCT02755753
    Other Study ID Numbers:
    • 037-OTC-1201i
    First Posted:
    Apr 29, 2016
    Last Update Posted:
    Apr 29, 2016
    Last Verified:
    Apr 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by YongChan Lee, Professor, Severance Hospital
    Rebamipide
    Additional relevant MeSH terms:
    Gastroesophageal Reflux
    Esophagitis
    Esophagitis, Peptic
    Lansoprazole
    Dexlansoprazole
    Rebamipide

    Study Results

    No Results Posted as of Apr 29, 2016