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

• Status: Completed
• Trial end date: 2018-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Il-Yang Pharm. Co., Ltd.
• Treatments: Rabeprazole

Criteria

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