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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03219723 |
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Date of registration:
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09/07/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Drug Use Surveillance of Takecab for "Supplement to Helicobacter Pylori Eradication"
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Scientific title:
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Drug Use Surveillance of Takecab Tablets "Supplement to Helicobacter Pylori Eradication" |
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Date of first enrolment:
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September 1, 2015 |
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Target sample size:
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560 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03219723 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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Japan
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Contacts
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Name:
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Study Director |
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Address:
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Telephone:
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Email:
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Affiliation:
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Takeda |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Participants receiving H. pylori eradication treatment for the first time
- Participants for whom H. pylori eradication with Takecab tablets or proton pump
inhibitor + amoxicillin + clarithromycin was found unsuccessful and who will receive
eradication treatment with amoxicillin and metronidazole
Exclusion Criteria:
- Participants with previous history of hypersensitivity to ingredients in Takecab
tablets
- Participants taking atazanavir sulfate or rilpivirine hydrochloride
Age minimum:
N/A
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Gastric/Duodenal Ulcer, Gastric MALT Lymphoma, Idiopathic Thrombocytopenic Purpura, or H. Pylori Gastritis, and Other
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Intervention(s)
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Drug: Vonoprazan
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Drug: Metronidazole
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Drug: Amoxicillin hydrate
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Drug: Clarithromycin
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Primary Outcome(s)
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Percentage of Participants Who Had One or More Adverse Drug Reactions
[Time Frame: Up to 7 days and 2 months]
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Secondary Outcome(s)
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H. Pylori Eradication Rate
[Time Frame: 7 days + 2 months]
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Secondary ID(s)
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Vonoprazan-5002
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JapicCTI-153003
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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