None listed
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: -Patients aged 18 to 75 years who are scheduled to undergo endoscopic submucosal dissection for early gastric cancer or gastric adenoma measuring =15 mm. -Patients who voluntarily provide written informed consent to participate in this study.
Exclusion criteria
Exclusion criteria: -Patients with a history of hypersensitivity or allergy to the investigational drug (Noltec®) or other proton pump inhibitors (PPIs). -Patients in whom the use of the investigational drug is contraindicated because of potential drug interactions. -Patients who require continuous treatment with medications that may induce or aggravate gastric ulcers, including nonsteroidal anti-inflammatory drugs (NSAIDs), antiplatelet agents (including aspirin), or anticoagulants. -Patients with significant cardiovascular disease (New York Heart Association [NYHA] class III or IV) or significant respiratory disease. -Patients with clinically significant abnormal laboratory findings at screening, including: -Aspartate aminotransferase (AST), alanine aminotransferase (ALT), or total bilirubin =2 times the upper limit of normal (ULN) at the study site; -Blood urea nitrogen (BUN) or serum creatinine =2 times the upper limit of normal (ULN) at the study site. -Patients with clinically significant abnormal electrocardiographic (ECG) findings. -Pregnant or breastfeeding women. -Patients with dementia, cognitive impairment, or impaired consciousness. -Patients who do not provide written informed consent to participate in this study. -Patients who have participated in another clinical trial within 30 days before enrollment in this study. -Patients whom the principal investigator or sub-investigator considers unsuitable for participation in this study for any other reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ulcer reduction rate at 4 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Scar-stage healing rate | — |
Countries
Korea, Republic of
Contacts
Pusan National University Yangsan Hospital