Gastric Cancer
Conditions
Keywords
Ilaprazole, Gastric Adenoma, Early Gastric Cancer, Endoscopic Submucosal Dissection
Brief 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.
Detailed 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.
Interventions
DRUGIlaprazole
Ilaprazole 10mg 2tablets once a day(1 times / day), before breakfast
DRUGRabeprazole
Rabeprazole 20mg 1tablets once a day(1 times / day), before breakfast
Sponsors
Il-Yang Pharm. Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Ulcer healing rate after endoscopic submucosal dissection | participants will be followed at 8 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The rate of Ulcer size reduction as assessed by measurements of ulcer size change. | at 8 weeks after treatment | The rate of Ulcer size reduction(Δ) : \[(Initial ulcer size) - (Ulcer size at 8 weeks)\] / (Initial ulcer size) |
| The quality of ulcer healing as evaluated by the observation of investigator at tracking endoscopy. | at 8 weeks after treatment | 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. |
| The evaluation of symptom score as assessed by the Korean Gastrointestinal Symptom Rating Scale questionnaire. | at 8 weeks after treatment | The Korean Gastrointestinal Symptom Rating Scale questionnaire measured the patient's symptom degree. |
Countries
South Korea
Outcome results
None listed