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This exploratory study is designed to compare safety and efficacy between a Tegoprazan dose-specific standard triple therapy and Lansoprazole standard triple therapy in H. pylori positive patients.
A Randomized, Double-Blind, Active-controlled, Multicenter, Therapeutic Exploratory Study to to Evaluate the Safety and Efficacy of a Standard Triple Therapy with Tegoprazan and Lansoprazole standard triple therapy in H. pylori Positive Patients, twice a day for 14 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tegoprazan 50 mg | Experimental | Tegoprazan 50 mg/Clarithromycin/ Amoxicillin BID peroral, 14 days |
|
| Tegoprazan 100 mg | Experimental | Tegoprazan 100 mg/Clarithromycin/ Amoxicillin BID peroral, 14 days |
|
| Lansoprazole | Active Comparator | Lansoprazolee/Clarithromycin/ Amoxicillin BID peroral, 14 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tegoprazan 50 mg Triple Therapy | Drug | Tegoprazan 50 mg/Clarithromycin/ Amoxicillin BID peroral, 14 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| H. pylori eradication rate | Assess H. pylori eradication rate by UBT | 42 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eun Ji Kim | Contact | 82-2-6477-0290 | eunji.kim24@inno-n.com | |
| Hee Hyun Kim | Contact | 82-2-6477-0258 | heehyun.kim@inno-n.com |
| Name | Affiliation | Role |
|---|---|---|
| Jae Gyu Kim | Chung-Ang University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chung-Ang University Hosptial | Recruiting | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41531249 | Derived | Park JY, Hong SJ, Choi IJ, Baik GH, Kim SM, Park JJ, Jeon SW, Kim KO, Lee SK, Jung HY, Oh JH, Park CH, Kim SW, Shim KN, Jee SR, Moon HS, Moon JS, Choi CW, Lee WS, Kim JG. Tegoprazan-Based Triple Therapy for Helicobacter pylori Eradication: A Phase III Multicenter Randomized Clinical Trial. Helicobacter. 2026 Jan-Feb;31(1):e70106. doi: 10.1111/hel.70106. |
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| ID | Term |
|---|---|
| C000631239 | tegoprazan |
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| Tegoprazan 100 mg Triple Therapy | Drug | Tegoprazan 100 mg/Clarithromycin/ Amoxicillin BID peroral, 14 days |
|
| Lansoprazole Triple Therapy | Drug | Lansoprazole/Clarithromycin/ Amoxicillin BID peroral, 14 days |
|