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
Not provided
Not provided
Not provided
Not provided
Not provided
To demonstrate the non-inferiority of Ilaprazole 10 mg to the active control in prevention of NSAIDs-associated peptic ulcer, as assessed by the proportion of subjects with peptic ulcer by Week 24
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ilaprazole 10 mg | Experimental | Take Ilaprazole 10 mg 1 tablet + Placebo of Lansoprazole 15 mg 1 capsule by mouth, with water, once daily. |
|
| Lansoprazole 15 mg | Active Comparator | Take Lansoprazole 15 mg 1 capsule + Placebo of Ilaprazole 10 mg 1 tablet by mouth, with water, once daily. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ilaprazole | Drug | Ilaprazole 10 mg |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Ilaprazole, Lansoprazole peptic ulcer | Proportion of subjects with newly developed peptic ulcer until Week 24 after the IP treatment | at 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Ilaprazole, Lansoprazole peptic ulcer | Proportion of subjects with newly developed peptic ulcer until Week 12 after the IP treatment | at 12 weeks |
| Ilaprazole, Lansoprazole GI bleeding | Proportion of subjects with upper GI bleeding by Week 12 and Week 24 after the IP treatment |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| JungHwa Hong, Master | Contact | +82.2.570.3777 | jhhong@ilyang.co.kr | |
| JeongSu Wi, bachelor | Contact | +82.2.570.3778 | jswi@ilyang.co.kr |
| Name | Affiliation | Role |
|---|---|---|
| JungSoo Song, M.D. | Chung-Ang University Hospital Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chung Ang University Hospital | Recruiting | Seoul | South Korea |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010437 | Peptic Ulcer |
| ID | Term |
|---|---|
| D004378 | Duodenal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C119615 | ilaprazole |
| D064747 | Lansoprazole |
| 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
| Lansoprazole | Drug | Lansoprazole 15 mg |
|
|
| Ilaprazole Placebo | Drug | Placebo of Ilaprazole 10 mg |
|
|
| Lansoprazole Placebo | Drug | Placebo of Lansoprazole 15 mg |
|
|
| at 12, 24 weeks |
| Chung-Ang University Hospital | Recruiting | Seoul | South Korea |
|
| 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 |