Effects of Ilaprazole on Ulcer Healing Rate and Prevention of Gastrointestinal Bleeding in the Patients Undergone ESD.

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effects of Ilaprazole 20mg on Ulcer Healing Rate and Prevention of Gastrointestinal Bleeding in the Patients Undergone Endoscopic Submucosal Dissection(ESD) for Gastric Adenoma or Early Gastric Cancer.

Conditions
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Gastric Cancer

Intervention / Treatment
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* Drug: Ilaprazole
* Drug: Rabeprazole


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 19 year old ≤ Male or female < 85 year old Subject who underwent Endoscopic Submucosal Dissection for Gastric Adenoma or Early Gastric Cancer Subject who agrees to participate and spontaneously sign the Informed consent form(ICF). 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 Total Bilirubin, Creatinine> 1.5 times upper limit of normal Alanine transaminase(ALT), Aspartate transaminase(AST), Alkaline phosphatase, Blood urea nitrogen(BUN)> 2 times upper limit of normal 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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ilaprazole<br>Ilaprazole tab 10mg, 2 tablets once daily for 8 weeks. | Drug: Ilaprazole<br>* Ilaprazole 10mg 2tablets once a day(1 times / day), before breakfast<br>* Other names: Ilaprazole(Noltec®);|
| Active Comparator: Rabeprazole<br>Rabeprazole tab 20mg, 1 tablet once daily for 8 weeks. | Drug: Rabeprazole<br>* Rabeprazole 20mg 1tablets once a day(1 times / day), before breakfast<br>* Other names: Pariet®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Ulcer healing rate after endoscopic submucosal dissection |  | participants will be followed at 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of Ulcer size reduction as assessed by measurements of ulcer size change. | The rate of Ulcer size reduction(Δ) : [(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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ilaprazole, Gastric Adenoma, Early Gastric Cancer, Endoscopic Submucosal Dissection