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The current study is designed to demonstrate the non-inferiority of CJ-12420-based triple therapy (CJ-12420, amoxicillin and clarithromycin) versus lansoprazole-based triple therapy (lansoprazole, amoxicillin and clarithromycin) in H. pylori eradication rate and to evaluate the safety of CJ-12420 following oral administration of either triple therapy twice daily for 7 days in H. pylori positive patients.
This is a double blind, randomized, active controlled, phase 3 study. Subjects will be randomly assigned to one of the two treatment groups (CJ-12420 50mg, lansoprazole 30mg). All subjects will be asked to take 5 tablets include clarithromycin, amoxicillin twice a day for 7 days.
After the treatment, UBT test will be conducted to confirm the Helicobacter pylori eradication.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CJ-12420/Clarithromycin/Amoxicillin | Experimental | CJ-12420 50mg /Clarithromycin 500mg /Amoxicillin 1g |
|
| Lansoprazole/Clarithromycin/Amoxicillin | Active Comparator | Lansoprazole 30mg /Clarithromycin 500mg /Amoxicillin 1g |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CJ-12420/Clarithromycin/Amoxicillin | Drug | CJ-12420 or Lansoprazole +Clarithromycin/Amoxicillin will be administrated twice a day, for 7 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| H. pylori eradication rate | Subjects will be considered to succeed in achieving H. pylori eradication if subject's UBT test (Eradication Assessment) | twice a day |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yong Chan Lee | Severance Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yonsei University Severance Hospital | Seoul | 03722 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35791797 | Derived | Choi YJ, Lee YC, Kim JM, Kim JI, Moon JS, Lim YJ, Baik GH, Son BK, Lee HL, Kim KO, Kim N, Ko KH, Jung HK, Shim KN, Chun HJ, Kim BW, Lee H, Kim JH, Chung H, Kim SG, Jang JY. Triple Therapy-Based on Tegoprazan, a New Potassium-Competitive Acid Blocker, for First-Line Treatment of Helicobacter pylori Infection: A Randomized, Double-Blind, Phase III, Clinical Trial. Gut Liver. 2022 Jul 15;16(4):535-546. doi: 10.5009/gnl220055. Epub 2022 Jul 6. |
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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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|
| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |