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

NCT02755753 | Completed Phase 4

• 1 other identifier: 037-OTC-1201i
• Study Type: interventional
• Target: 143
• Locations: 2 countries
• Sites: 5

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).

Conditions

Gastroesophageal Reflux

Keywords

Rebamipide

Outcome Measures

Primary Outcomes (1)

• Endoscopic healing rate

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

  4 weeks

Secondary Outcomes (5)

• Histologic change

  4 weeks

• Change in inflammatory cytokines

  4 weeks

• Time to complete symptom relief

  every 2 week, up to 4 week

• Overall symptom relief

  every 2 week, up to 4 week

• Adverse events profile

  every 2 week, up to 4week

Study Arms (2)

Study Group

EXPERIMENTAL

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; Drug: Rebamipide

Control Group

PLACEBO COMPARATOR

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; Drug: Rebamipide-placebo

Interventions

Lansoprazole DRUG

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

Also known as: Lanston

Control Group; Study Group

Rebamipide DRUG

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

Also known as: Mucosta

Study Group

Rebamipide-placebo DRUG

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

Also known as: Mucosta-placebo

Control Group

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• YongChan Lee: lead
• Otsuka Pharmaceutical Co., Ltd.: collaborator

Study Sites (5)

Yang Shiming

Chongqing, Chongqing Municipality, 400037, China

Location

Soonchunhyang University Bucheon Hospital

Bucheon-si, South Korea

Location

Kyungpook National University Medical Center

Daegu, South Korea

Location

Konyang University Hospital

Daejeon, South Korea

Location

Severance Hospital, Yonsei University Health System

Seoul, South Korea

Location

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  PMID: 21028753 RESULT

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

Lansoprazole; rebamipide

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 2, 2015
• First Posted: April 29, 2016
• Study Start: January 1, 2014
• Primary Completion: January 1, 2016
• Study Completion: April 1, 2016
• Last Updated: April 29, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1); KR (4)