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

Il-Yang Pharmaceutical

Status and phase

Completed

Phase 4

Conditions

Gastric Cancer

Treatments

Drug: Rabeprazole

Drug: Ilaprazole

Study type

Interventional

Funder types

Industry

Identifiers

NCT02638584

HUMC-ILA01

Details and patient eligibility

About

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.

Full description

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.

Enrollment

176 patients

Sex

All

Ages

19 to 85 years old

Volunteers

No Healthy Volunteers

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