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To demonstrate non-inferiority of CJ-12420 to lansoprazole 30 mg capsule in terms of therapeutic efficacy, and to confirm safety of CJ-12420, after once daily oral administration of CJ-12420 50 mg, 100 mg or Lansoprazole 30 mg capsule in gastric ulcer patients.
This is a double blind, randomized, placebo-controlled, phase 3 study. Subjects will be randomly assigned to one of the three treatment groups (CJ-12420 50 mg, 100 mg or Lansoprazole 30 mg).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CJ-12420 50 mg QD | Experimental | CJ-12420 50 mg, tablet, once daily, oral administration for up to 8 weeks |
|
| CJ-12420 100 mg QD | Experimental | CJ-12420 100 mg, tablet, once daily, oral administration for up to 8 weeks |
|
| Lansoprazole 30 mg QD | Active Comparator | Lansoprazole 30 mg, capsule, once daily, oral administration for up to 8 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CJ-12420 50 mg QD | Drug | CJ-12420 50 mg tablets will be orally administered, once daily, for up to 8 weeks. For subjects whose gastric ulcer is not endoscopically healed(S1 or S2 stage) at Week 4, subjects will receive additional 4 weeks treatment of CJ-12420 50 mg. |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative healing rate of gastric ulcer at 8-week | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Healing rate of gastric ulcer at 4-week | 4 weeks | |
| Week 8 healing rates by H. pylori infection | 8 weeks |
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Inclusion Criteria:
1. Diagnosis of 1 or more active gastric ulcers (≥3 mm ~ ≤30 mm using open biopsy forceps) according to the Sakita-Miwa classification (A1 or A2 stage) from upper GI endoscopy at the same institution within 14 days prior to initiation of the investigational product administration.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Myung Gyu Choi, M.D., Ph.D | Catholic Univ. Seoul St. Mary Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Catholic Univ. Seoul St. Mary Hospita | Seoul | South Korea | ||||
| Kyung Hee University Medical Center |
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| ID | Term |
|---|---|
| D013276 | Stomach Ulcer |
| ID | Term |
|---|---|
| D010437 | Peptic Ulcer |
| D004378 | Duodenal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D064747 | Lansoprazole |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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|
| CJ-12420 100 mg QD | Drug | CJ-12420 100 mg tablets will be orally administered, once daily, for up to 8 weeks. For subjects whose gastric ulcer is not endoscopically healed(S1 or S2 stage) at Week 4, subjects will receive additional 4 weeks treatment of CJ-12420 100 mg. |
|
|
| Lansoprazole 30 mg QD | Drug | Lansoprazole 30 mg capsule will be orally administered, once daily, for up to 8 weeks. For subjects whose gastric ulcer is not endoscopically healed(S1 or S2 stage) at Week 4, subjects will receive additional 4 weeks treatment of Lansoprazole 30 mg. |
|
|
| Seoul |
| South Korea |
| D004066 |
| Digestive System Diseases |
| D013272 | Stomach Diseases |
| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |