Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Janssen Korea, Ltd., Korea | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is:
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| rabeprazole | Experimental | rabeprazole |
|
| placebo | Experimental | placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rabeprazole | Drug | The rabeprazole group will receive oral rabeprazole 20mg twice day (morning and evening) 30 minutes before meals from 5 days before EMR (D-5) to 1 day before EMR (D-1). |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of bleeding after EMR is performed | 4weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number (No./cm2) of visible vessels on the fundus of ulcer on endoscopy performed within 24 hours after EMR | day 1 | |
| Percentage of a pH change with intragastric pH greater than 6 in 24 hours after EMR | day 0 |
Not provided
Inclusion Criteria:
Patients who have EMR planned as well as meet the criteria described below will be selected as study subjects
Patients in whom EMR is indicated:
Gastric adenoma
Early gastric adenocarcinoma
EMR to be performed for other diagnostic purposes
Women of child-bearing potential should avoid pregnancy
Subjects who consented to a EMR procedure in writing
Exclusion Criteria:
Patients who meet the criteria described below should be excluded from study subjects:
Patients with bleeding tendency
Patients with esophageal varices
Patients with esophageal ulcer, stricture, or obstruction
Patients who have pacemaker or implantable cardiac defibrillator in place
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| MyungKu Choi, MD | The Catholic University of Korea | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Catholic University, Gangnam St. Mary's Hospital | Seoul | Ban-po Dong 505 | 137-040 | South Korea |
Not provided
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D006471 | Gastrointestinal Hemorrhage |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D064750 | Rabeprazole |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| placebo | Drug | The placebo group will receive a placebo by mouth twice a day (morning and evening) 30 minutes before meals from 5 days before EMR (D-5) to 1 day before EMR (D-1). |
|
| Measurement of a change in the size of ulcer | 4weeks |
| D005767 |
| Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |