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| Name | Class |
|---|---|
| Otsuka Pharmaceutical Co., Ltd. | INDUSTRY |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Group | Experimental |
|
|
| Control Group | Placebo Comparator |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lansoprazole | Drug | Oral administration of Lanston® (lansoprazole) 30 mg, 1 capsule, PO, qd, 30 min before breakfast |
|
| Measure | Description | Time Frame |
|---|---|---|
| Endoscopic healing rate | The ratio of the endoscopically completely healed (normal or minimal change) patients per groups | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Histologic change | Histologic change defined with Hematoxylin and eosin (H&E) stain | 4 weeks |
| Change in inflammatory cytokines | Change in the tissue level of Platelet activating factor (PAF) and Interleukin-8 (IL-8) |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yang Shiming | Chongqing | Chongqing Municipality | 400037 | China | ||
| Soonchunhyang University Bucheon Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23236223 | Background | 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. | |
| 16928254 | Background | 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. |
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| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D064747 | Lansoprazole |
| C052785 | rebamipide |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| Rebamipide | Drug | Oral administration of Mucosta (rebamipide) 100 mg, 1 tablet, PO, tid, 30 minutes before breakfast, lunch, and dinner |
|
|
| Rebamipide-placebo | Drug | Oral administration of Mucosta®-placebo, 1 tablet, PO, tid, 30 minutes before breakfast, lunch and dinner |
|
|
| 4 weeks |
| Time to complete symptom relief | Interval between inital medication and the first time of symptom relief judged by subject's diary | every 2 week, up to 4 week |
| Overall symptom relief | The proportion of relieved subjects at the end of treatment | every 2 week, up to 4 week |
| Adverse events profile | patient's symptoms, physical findings, abnormal laboratory values, vital signs, and ECG findings | every 2 week, up to 4week |
| 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 |
| 22885331 | Background | 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. |
| 19054260 | Background | 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. |
| 15831922 | Background | 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. |
| 15379831 | Background | 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. |
| 21916988 | Background | 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. |
| 21369492 | Background | 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. |
| 11354273 | Background | 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. |
| 19458464 | Background | 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. |
| 21532855 | Background | 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. |
| 17645475 | Background | 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. |
| 14524732 | Background | 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. |
| 19582579 | Background | 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. |
| 12620183 | Background | Howden CW, Chey WD. Gastroesophageal reflux disease. J Fam Pract. 2003 Mar;52(3):240-7. |
| 21350318 | Background | 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. |
| 19267194 | Background | 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. |
| 20198424 | Background | 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. |
| 9146777 | Background | 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. |
| 15189396 | Background | 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. |
| 16568367 | Background | 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. |
| 10343212 | Background | 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. |
| 21459338 | Background | 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. |
| 21028753 | Result | 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/ |
| D004066 | Digestive System Diseases |
| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |