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CompletedNCT02755753REPAIRUpdated Apr 29, 2016

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

A Phase 4 interventional study of Lansoprazole and Rebamipide in Gastroesophageal Reflux, sponsored by YongChan Lee. Completed at 5 sites in 2 countries. Open to participants aged 20 Years to 70 Years. Per ClinicalTrials.gov, last updated 2016-04-29.

Sponsored by YongChan Lee · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
143
Allocation
Randomized
Ages
20 Years to 70 Years
Sex
All
01

Study 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).

Read the 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)
02

Conditions studied

  • Gastroesophageal Reflux

Keywords

  • Rebamipide
03

In context

Gastroesophageal Reflux

1,067 studies on the registry are indexed under Gastroesophageal Reflux; 188 are open to participants now.

This study's enrollment of 143 is above the median of 72 across 712 interventional studies indexed under Gastroesophageal Reflux.

Browse Gastroesophageal Reflux studies →

Lead sponsor

This is the only study on the registry with YongChan Lee as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 70 Years
Sexes eligible
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.

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

Exclusion criteria

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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
143 participants (actual)

Study arms

  • 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 · Drug: Rebamipide

  • 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 · Drug: Rebamipide-placebo

Interventions

  • DrugLansoprazole

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

    Also known as: Lanston

  • DrugRebamipide

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

    Also known as: Mucosta

  • DrugRebamipide-placebo

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

    Also known as: Mucosta-placebo

06

What researchers measure

Primary outcomes

  1. Endoscopic healing rate

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

    Time frame: 4 weeks

Secondary outcomes

  1. Histologic change

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

    Time frame: 4 weeks

  2. Change in inflammatory cytokines

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

    Time frame: 4 weeks

  3. Time to complete symptom relief

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

    Time frame: every 2 week, up to 4 week

  4. Overall symptom relief

    The proportion of relieved subjects at the end of treatment

    Time frame: every 2 week, up to 4 week

  5. Adverse events profile

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

    Time frame: every 2 week, up to 4week

07

Study locations

5 sites
  • Yang Shiming
    Chongqing, Chongqing 400037, China
  • Soonchunhyang University Bucheon Hospital
    Bucheon, Korea, Republic of
  • Kyungpook National University Medical Center
    Daegu, Korea, Republic of
  • Konyang University Hospital
    Daejeon, Korea, Republic of
  • Severance Hospital, Yonsei University Health System
    Seoul, Korea, Republic of
08

References and documents

Publications

  • Chai J, Jamal MM. Esophageal malignancy: a growing concern. World J Gastroenterol. 2012 Dec 7;18(45):6521-6. doi: 10.3748/wjg.v18.i45.6521. PubMed 23236223 ↗
  • Vakil N, van Zanten SV, Kahrilas P, Dent J, Jones R; Global Consensus Group. The Montreal definition and classification of gastroesophageal reflux disease: a global evidence-based consensus. Am J Gastroenterol. 2006 Aug;101(8):1900-20; quiz 1943. doi: 10.1111/j.1572-0241.2006.00630.x. PubMed 16928254 ↗
  • Peery AF, Dellon ES, Lund J, Crockett SD, McGowan CE, Bulsiewicz WJ, Gangarosa LM, Thiny MT, Stizenberg K, Morgan DR, Ringel Y, Kim HP, DiBonaventura MD, Carroll CF, Allen JK, Cook SF, Sandler RS, Kappelman MD, Shaheen NJ. Burden of gastrointestinal disease in the United States: 2012 update. Gastroenterology. 2012 Nov;143(5):1179-1187.e3. doi: 10.1053/j.gastro.2012.08.002. Epub 2012 Aug 8. PubMed 22885331 ↗
  • Wong RK, Yeoh KG, Gwee KA, Tay HW, Ho KY. Validation of structured scoring using the LA classification for esophagitis and endoscopically suspected Barrett's esophagus in a tertiary Asian endoscopy center. J Gastroenterol Hepatol. 2009 Jan;24(1):103-6. doi: 10.1111/j.1440-1746.2008.05680.x. Epub 2008 Dec 1. PubMed 19054260 ↗
  • Dent J, El-Serag HB, Wallander MA, Johansson S. Epidemiology of gastro-oesophageal reflux disease: a systematic review. Gut. 2005 May;54(5):710-7. doi: 10.1136/gut.2004.051821. PubMed 15831922 ↗
  • Kang JY. Systematic review: geographical and ethnic differences in gastro-oesophageal reflux disease. Aliment Pharmacol Ther. 2004 Oct 1;20(7):705-17. doi: 10.1111/j.1365-2036.2004.02165.x. PubMed 15379831 ↗
  • Kim KM, Cho YK, Bae SJ, Kim DS, Shim KN, Kim JH, Jung SW, Kim N. Prevalence of gastroesophageal reflux disease in Korea and associated health-care utilization: a national population-based study. J Gastroenterol Hepatol. 2012 Apr;27(4):741-5. doi: 10.1111/j.1440-1746.2011.06921.x. PubMed 21916988 ↗
  • Song JH, Chung SJ, Lee JH, Kim YH, Chang DK, Son HJ, Kim JJ, Rhee JC, Rhee PL. Relationship between gastroesophageal reflux symptoms and dietary factors in Korea. J Neurogastroenterol Motil. 2011 Jan;17(1):54-60. doi: 10.5056/jnm.2011.17.1.54. Epub 2011 Jan 26. PubMed 21369492 ↗
  • Lee SJ, Song CW, Jeen YT, Chun HJ, Lee HS, Um SH, Lee SW, Choi JH, Kim CD, Ryu HS, Hyun JH. Prevalence of endoscopic reflux esophagitis among Koreans. J Gastroenterol Hepatol. 2001 Apr;16(4):373-6. doi: 10.1046/j.1440-1746.2001.02464.x. PubMed 11354273 ↗
  • Hwang JK, Kim J, Hong SG, Jung SJ, Joo MK, Lee BJ, Park JJ, Kim JS, Bak YT. [A prospective multicenter study on the prevalence and symptoms of erosive reflux esophagitis in secondary and tertiary hospitals in Korea]. Korean J Gastroenterol. 2009 May;53(5):283-91. doi: 10.4166/kjg.2009.53.5.283. Korean. PubMed 19458464 ↗
  • Kim BJ, Cheon WS, Oh HC, Kim JW, Park JD, Kim JG. Prevalence and risk factor of erosive esophagitis observed in Korean National Cancer Screening Program. J Korean Med Sci. 2011 May;26(5):642-6. doi: 10.3346/jkms.2011.26.5.642. Epub 2011 Apr 21. PubMed 21532855 ↗
  • Li YM, Du J, Zhang H, Yu CH. Epidemiological investigation in outpatients with symptomatic gastroesophageal reflux from the Department of Medicine in Zhejiang Province, east China. J Gastroenterol Hepatol. 2008 Feb;23(2):283-9. doi: 10.1111/j.1440-1746.2007.05045.x. Epub 2007 Jul 20. PubMed 17645475 ↗
  • Shaw MJ, Crawley JA. Improving health-related quality of life in gastro-oesophageal reflux disease. Drugs. 2003;63(21):2307-16. doi: 10.2165/00003495-200363210-00003. PubMed 14524732 ↗
  • Kovacs TO, Freston JW, Haber MM, Atkinson S, Hunt B, Peura DA. Long-term quality of life improvement in subjects with healed erosive esophagitis: treatment with lansoprazole. Dig Dis Sci. 2010 May;55(5):1325-36. doi: 10.1007/s10620-009-0871-8. Epub 2009 Jul 7. PubMed 19582579 ↗
  • Howden CW, Chey WD. Gastroesophageal reflux disease. J Fam Pract. 2003 Mar;52(3):240-7. PubMed 12620183 ↗
  • Lee JH, Cho YK, Jeon SW, Kim JH, Kim NY, Lee JS, Bak YT; Korean Society of Neurogastroenterology and Motility. [Guidelines for the treatment of gastroesophageal reflux disease]. Korean J Gastroenterol. 2011 Feb;57(2):57-66. doi: 10.4166/kjg.2011.57.2.57. Korean. PubMed 21350318 ↗
  • Kovacs TO, Freston JW, Haber MM, Hunt B, Atkinson S, Peura DA. Long-term efficacy of lansoprazole in preventing relapse of erosive reflux esophagitis. Dig Dis Sci. 2009 Aug;54(8):1693-701. doi: 10.1007/s10620-009-0769-5. Epub 2009 Mar 7. PubMed 19267194 ↗
  • Yoshida N, Kamada K, Tomatsuri N, Suzuki T, Takagi T, Ichikawa H, Yoshikawa T. Management of recurrence of symptoms of gastroesophageal reflux disease: synergistic effect of rebamipide with 15 mg lansoprazole. Dig Dis Sci. 2010 Dec;55(12):3393-8. doi: 10.1007/s10620-010-1166-9. Epub 2010 Mar 3. PubMed 20198424 ↗
  • Hatlebakk JG, Berstad A. Lansoprazole 15 and 30 mg daily in maintaining healing and symptom relief in patients with reflux oesophagitis. Aliment Pharmacol Ther. 1997 Apr;11(2):365-72. doi: 10.1046/j.1365-2036.1997.144320000.x. PubMed 9146777 ↗
  • Lancaster GA, Dodd S, Williamson PR. Design and analysis of pilot studies: recommendations for good practice. J Eval Clin Pract. 2004 May;10(2):307-12. doi: 10.1111/j..2002.384.doc.x. PubMed 15189396 ↗
  • Hongo M. Minimal changes in reflux esophagitis: red ones and white ones. J Gastroenterol. 2006 Feb;41(2):95-9. doi: 10.1007/s00535-006-1775-4. PubMed 16568367 ↗
  • Kusano M, Ino K, Yamada T, Kawamura O, Toki M, Ohwada T, Kikuchi K, Shirota T, Kimura M, Miyazaki M, Nakamura K, Igarashi S, Tomizawa M, Tamura T, Sekiguchi T, Mori M. Interobserver and intraobserver variation in endoscopic assessment of GERD using the "Los Angeles" classification. Gastrointest Endosc. 1999 Jun;49(6):700-4. doi: 10.1016/s0016-5107(99)70285-3. PubMed 10343212 ↗
  • Fiocca R, Mastracci L, Milione M, Parente P, Savarino V; Gruppo Italiano Patologi Apparato Digerente (GIPAD); Societa Italiana di Anatomia Patologica e Citopatologia Diagnostica/International Academy of Pathology, Italian division (SIAPEC/IAP). Microscopic esophagitis and Barrett's esophagus: the histology report. Dig Liver Dis. 2011 Mar;43 Suppl 4:S319-30. doi: 10.1016/S1590-8658(11)60588-4. PubMed 21459338 ↗
  • Holzheimer RG, Mannick JA, editors. Surgical Treatment: Evidence-Based and Problem-Oriented. Munich: Zuckschwerdt; 2001. Available from http://www.ncbi.nlm.nih.gov/books/NBK6880/ PubMed 21028753 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 29, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02755753
Lead sponsor
YongChan Lee
Collaborators
Otsuka Pharmaceutical Co., Ltd.
Responsible party
YongChan Lee (Professor, Severance Hospital) — Sponsor-investigator
First posted
Apr 29, 2016
Start date
Jan 2014
Primary completion
Jan 2016
Completion
Apr 2016
Last update
Apr 29, 2016

Study contacts

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

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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