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Gastroesophageal RefluxPhase 4REPAIRNCT02755753

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

A Phase 4 study testing Lansoprazole and Rebamipide in people with Gastroesophageal Reflux, run by YongChan Lee at 5 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 more about this study

Who is it for?
Ages 20 to 70 years
Conditions the study is for
Gastroesophageal Reflux
What is being tested?
Lansoprazole and Rebamipide
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
143 participants
Where
5 sitesin 2 countries
Study dates
Jan 2014to Apr 2016
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 11Show fewer
  • 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.

Trial locations and contacts

5 sites in 2 countries.

5 sites in 2 countries

South Korea4 sites

  • Soonchunhyang University Bucheon Hospital

    Bucheon-si

  • Kyungpook National University Medical Center

    Daegu

  • Konyang University Hospital

    Daejeon

  • Severance Hospital, Yonsei University Health System

    Seoul

Other trials in South Korea

China1 site

  • Yang Shiming

    Chongqing, Chongqing Municipality, 400037

Other trials in China

About this study

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)

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)
Being tested
Lansoprazole, Rebamipide, Rebamipide-placebo
Keywords
Rebamipide
Medical subject headings
Gastroesophageal Reflux

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LansoprazoleDrug

    Also called Lanston

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

  • RebamipideDrug

    Also called Mucosta

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

  • Rebamipide-placeboDrug

    Also called Mucosta-placebo

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

Study groups in NCT02755753
Study groupRoleWhat they receive
Study GroupExperimental1. 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
Receives: Drug: Lansoprazole; Drug: Rebamipide
Control GroupPlacebo comparator1. 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
Receives: Drug: Lansoprazole; Drug: Rebamipide-placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Endoscopic healing rate

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

    Measured: 4 weeks

Secondary outcomes (5)

  1. Histologic change

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

    Measured: 4 weeks

  2. Change in inflammatory cytokines

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

    Measured: 4 weeks

  3. Time to complete symptom relief

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

    Measured: every 2 week, up to 4 week

  4. Overall symptom relief

    The proportion of relieved subjects at the end of treatment

    Measured: every 2 week, up to 4 week

  5. Adverse events profile

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

    Measured: every 2 week, up to 4week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Apr 2016 (estimated)
  2. Study startJan 2014
  3. Primary completionJan 2016
  4. Study completionApr 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
143 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02755753
Sponsor's protocol ID
037-OTC-1201i
Acronym
REPAIR
Status last verified
Apr 2016
First submitted
2 Sep 2015
Last updated
29 Apr 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
No

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

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Lansoprazole and Rebamipide in people with Gastroesophageal Reflux, run by YongChan Lee at 5 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in South Korea, China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Endoscopic healing rate (time frame: 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02755753, which also lists 24 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2016; AzTrials last refreshed its copy on 3 Nov 2026.

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