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This study compared Ulcer healing rate of Ilaprazole 20mg or Rabeprazole 20mg in the patients undergone Endoscopic Submucosal Dissection for Gastric Adenoma or Early Gastric Cancer and investigated Prevention of gastrointestinal bleeding.
This study is a Multicenter, Randomized, Parallel and Prospective study to compare Ulcer healing rate of Ilaprazole 20mg or Rabeprazole 20mg in the patients undergone Endoscopic Submucosal Dissection for Gastric Adenoma or Early Gastric Cancer and to investigate Prevention of gastrointestinal bleeding.
Participants are defined as persons who underwent a Endoscopic Submucosal Dissection for Gastric Adenoma or Early Gastric Cancer. For 8 weeks, Participants treated as Ilaprazole 20mg or Rabeprazole 20mg once a day. After treatment, The ulcer healing rate was evaluated by Endoscopy at 4, 8 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ilaprazole | Experimental | Ilaprazole tab 10mg, 2 tablets once daily for 8 weeks. |
|
| Rabeprazole | Active Comparator | Rabeprazole tab 20mg, 1 tablet once daily for 8 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ilaprazole | Drug | Ilaprazole 10mg 2tablets once a day(1 times / day), before breakfast |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Ulcer healing rate after endoscopic submucosal dissection | participants will be followed at 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The rate of Ulcer size reduction as assessed by measurements of ulcer size change. | The rate of Ulcer size reduction(Ī) : [(Initial ulcer size) - (Ulcer size at 8 weeks)] / (Initial ulcer size) | at 8 weeks after treatment |
| The quality of ulcer healing as evaluated by the observation of investigator at tracking endoscopy. |
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Inclusion Criteria:
Exclusion Criteria:
Known hypersensitivity to any component of ilaprazole
Subjects who are taking contraindicated medications(ex. atazanavir) for experimental and concomitant drug.
Subjects with abnormal levels in the laboratory tests
Subjects diagnosed with other cancer within 5 years other than stomach cancer.
Subjects with a history of Zollinger-Ellison syndrome, Barrett's esophagus, primary esophageal motility abnormality, esophageal strictures, pancreatitis, malabsorption, severe cardiovascular or pulmonary disease
Subjects with a history of major surgery that can affect gastric acid secretion.
Subjects should continue taking the following medicine during the study period : anticholinergics, promoting motility agents, prostaglandin analogs, sucralfate, aspirin, steroid, NSAIDs drug
Subjects with uncontrolled organ failure (liver dysfunction, renal dysfunction)
Pregnant and/or lactating women
Subjects participating in a clinical trial before another trial within 30 days
Inconsistency judged subject by researcher
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| Name | Affiliation | Role |
|---|---|---|
| ChangSeok Bang, MD, PhD | HALLYM UNIVERSITY MEDICAL CENTER, Chuncheon Sacred Heart Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HALLYM UNIVERSITY MEDICAL CENTER, Chuncheon Sacred Heart Hospital | Chuncheon | Gangwon-do | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30167954 | Derived | Bang CS, Shin WG, Seo SI, Choi MH, Jang HJ, Park SW, Kae SH, Yang YJ, Shin SP, Baik GH, Kim HY. Effect of ilaprazole on the healing of endoscopic submucosal dissection-induced gastric ulcer: randomized-controlled, multicenter study. Surg Endosc. 2019 May;33(5):1376-1385. doi: 10.1007/s00464-018-6412-9. Epub 2018 Aug 30. |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C119615 | ilaprazole |
| D064750 | Rabeprazole |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| Rabeprazole | Drug | Rabeprazole 20mg 1tablets once a day(1 times / day), before breakfast |
|
|
Apply 0.15% Indigo carmine to scarring of the ulcer and Describe the pattern of the scar as flat, nodular or intermediate at tracking endoscopy. |
| at 8 weeks after treatment |
| The evaluation of symptom score as assessed by the Korean Gastrointestinal Symptom Rating Scale questionnaire. | The Korean Gastrointestinal Symptom Rating Scale questionnaire measured the patient's symptom degree. | at 8 weeks after treatment |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |