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Completed

NCT Number: NCT02755753

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

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).

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Key information

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Yang Shiming, Chongqing, Chongqing Municipality, China

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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

Exclusion criteria

  • Patients with known hypersensitivity to any component of Lanston® and/or Mucosta® formulations.
  • 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.
  • History of abdominal surgery that can affect gastrointestinal motility (except appendectomy and hysterectomy).
  • History of upper gastrointestinal bleeding or obstruction.
  • 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.
  • History of pancreatobiliary disease (except asymptomatic gallbladder stone), inflammatory bowel disease, cirrhotic liver disease, chronic kidney disease.
  • 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.
  • History of psychological disorder, alcoholics, and drug abuser.
  • 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.
  • Patients who previously underwent another clinical survey within 4 weeks.
  • History of major medical disease that can affect general condition and other patients deemed not eligible for this study by investigators.

Treatment and study plan

Lansoprazole

Drug

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

Other names: Lanston

rebamipide

Drug

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

Other names: Mucosta

Rebamipide-placebo

Drug

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

Other names: Mucosta-placebo

Primary outcomes

  1. Endoscopic healing rate

    Time frame: 4 weeks

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

Secondary outcomes

  1. Histologic change

    Time frame: 4 weeks

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

  2. Change in inflammatory cytokines

    Time frame: 4 weeks

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

  3. 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

  4. Overall symptom relief

    Time frame: every 2 week, up to 4 week

    The proportion of relieved subjects at the end of treatment

  5. Adverse events profile

    Time frame: every 2 week, up to 4week

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

Sponsors and collaborators

Lead sponsor

YongChan Lee

Other

Collaborators

  • Otsuka Pharmaceutical Co., Ltd.

Registry information

Official study 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)

Acronym: REPAIR

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Apr 29, 2016
Registry last updated
Apr 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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