Triple Therapy With Tegoprazan in H. Pylori Positive Patients
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|ClinicalTrials.gov Identifier: NCT03498456|
Recruitment Status : Completed
First Posted : April 13, 2018
Last Update Posted : May 8, 2020
|Condition or disease||Intervention/treatment||Phase|
|Helicobacter Pylori Infection||Drug: Tegoprazan/Amoxicillin/Clarithromycin Drug: Lansoprazole/Amoxicillin/Clarithromycin||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||284 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Phase 3, Randomized, Double-blind, Active-controlled, Multicenter Study to Evaluate the Efficacy and Safety of a Triple Therapy With Tegoprazan, Amoxicillin, and Clarithromycin in H. Pylori Positive Patients|
|Actual Study Start Date :||June 28, 2018|
|Actual Primary Completion Date :||December 31, 2019|
|Actual Study Completion Date :||December 31, 2019|
Tegoprazan 50 mg / Amoxicillin 1000 mg / Clarithromycin 500 mg
Tegoprazan 50 mg + Amoxicillin 1000 mg + Clarithromycin 500 mg bid. This therapy will be administered for a total of 7 days, in fasting conditions in the morning and the evening.
Other Name: Tegoprazan triple therapy (TAC)
Active Comparator: Lansoprazole/Amoxicillin/Clarithromycin
Lansoprazole 30 mg / Amoxicillin 1000 mg / Clarithromycin 500 mg
Lansoprazole 30 mg + Amoxicillin 1000 mg + Clarithromycin 500 mg bid. This therapy will be administered for a total of 7 days, in fasting conditions in the morning and the evening.
Other Name: Lansoprazole triple therapy (LAC)
- H. pylori eradication rate [ Time Frame: 6 weeks ]Subjects will be considered to succeed in achieving H. pylori eradication if subjects's negative UBT test.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03498456
|Korea, Republic of|
|Asan Medical Center|
|Seoul, Korea, Republic of|
|Principal Investigator:||Hwoon Yong Jung, Professor||Asan Medical Center|