A Phase 3 Study to Evaluate the Efficacy and Safety of Triple Therapy With CJ-12420 in H. Pylori Positive Patients
NCT ID: NCT03317223
Last Updated: 2021-10-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
350 participants
INTERVENTIONAL
2017-10-17
2019-01-24
Brief Summary
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Detailed Description
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After the treatment, UBT test will be conducted to confirm the Helicobacter pylori eradication.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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CJ-12420/Clarithromycin/Amoxicillin
CJ-12420 50mg /Clarithromycin 500mg /Amoxicillin 1g
CJ-12420/Clarithromycin/Amoxicillin
CJ-12420 or Lansoprazole +Clarithromycin/Amoxicillin will be administrated twice a day, for 7 days
Lansoprazole/Clarithromycin/Amoxicillin
Lansoprazole 30mg /Clarithromycin 500mg /Amoxicillin 1g
CJ-12420/Clarithromycin/Amoxicillin
CJ-12420 or Lansoprazole +Clarithromycin/Amoxicillin will be administrated twice a day, for 7 days
Interventions
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CJ-12420/Clarithromycin/Amoxicillin
CJ-12420 or Lansoprazole +Clarithromycin/Amoxicillin will be administrated twice a day, for 7 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Complain of gastric discomfort symptom
Exclusion Criteria
* Prior use of proton pump inhibitors (PPIs), H2 receptor blockers, at a full dosage within 14 days
* Prior use of H. pylori eradication effective antibiotics, bismuth within 14 days
20 Years
75 Years
ALL
No
Sponsors
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HK inno.N Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Yong Chan Lee
Role: PRINCIPAL_INVESTIGATOR
Severance Hospital
Locations
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Yonsei University Severance Hospital
Seoul, , South Korea
Countries
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References
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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.
Other Identifiers
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CJ_APA_306
Identifier Type: -
Identifier Source: org_study_id