A Study to Evaluate REbamiPide as an Adjuvant Regimen to Heal erosIve Reflux Esophagitis
NCT ID: NCT02755753
Last Updated: 2016-04-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
143 participants
INTERVENTIONAL
2014-01-31
2016-04-30
Brief Summary
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Detailed Description
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2. To evaluate the safety of rebamipide as an adjuvant regimen in erosive reflux esophagitis (ERE)
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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
Lansoprazole
Oral administration of Lanston® (lansoprazole) 30 mg, 1 capsule, PO, qd, 30 min before breakfast
Rebamipide
Oral administration of Mucosta (rebamipide) 100 mg, 1 tablet, PO, tid, 30 minutes before breakfast, lunch, and dinner
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
Lansoprazole
Oral administration of Lanston® (lansoprazole) 30 mg, 1 capsule, PO, qd, 30 min before breakfast
Rebamipide-placebo
Oral administration of Mucosta®-placebo, 1 tablet, PO, tid, 30 minutes before breakfast, lunch and dinner
Interventions
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Lansoprazole
Oral administration of Lanston® (lansoprazole) 30 mg, 1 capsule, PO, qd, 30 min before breakfast
Rebamipide
Oral administration of Mucosta (rebamipide) 100 mg, 1 tablet, PO, tid, 30 minutes before breakfast, lunch, and dinner
Rebamipide-placebo
Oral administration of Mucosta®-placebo, 1 tablet, PO, tid, 30 minutes before breakfast, lunch and dinner
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
20 Years
70 Years
ALL
No
Sponsors
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Otsuka Pharmaceutical Co., Ltd.
INDUSTRY
YongChan Lee
OTHER
Responsible Party
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YongChan Lee
Professor
Principal Investigators
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Yong Chan Lee, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Severance Hospital, Yonsei University Health System
Seong Woo Jeon, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Kyungpook National University Medical Center
Su Jin Hong, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Soonchunhyang University Buchen Hospital
Kyung Ho Song, MD, Master
Role: PRINCIPAL_INVESTIGATOR
Konyang University Hospital
Shiming Yang, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Xinqiao Hospital of Chongqing
Locations
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Yang Shiming
Chongqing, Chongqing Municipality, China
Soonchunhyang University Bucheon Hospital
Bucheon-si, , South Korea
Kyungpook National University Medical Center
Daegu, , South Korea
Konyang University Hospital
Daejeon, , South Korea
Severance Hospital, Yonsei University Health System
Seoul, , South Korea
Countries
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References
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Other Identifiers
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037-OTC-1201i
Identifier Type: -
Identifier Source: org_study_id