JRCT ID: jRCTs031180412
Registered date:22/03/2019
The efficacy of H. pylori eradication therapy with sitafloxacin-metronidazole-vonaprazan regimen
Basic Information
Recruitment status | Recruiting |
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Health condition(s) or Problem(s) studied | Helicobacter pylori infection |
Date of first enrollment | 09/05/2016 |
Target sample size | 100 |
Countries of recruitment | |
Study type | Interventional |
Intervention(s) | vonaprazan 40mg, b.i.d., metronidazole 500mg b.i.d, sitafloxacin 200 mg, b.i.d. |
Outcome(s)
Primary Outcome | The efficacy of eradication treatment |
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Secondary Outcome | 1) adverse events 2) MIC of STFX,MNZ, gyrA mutation |
Key inclusion & exclusion criteria
Age minimum | >= 20age old |
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Age maximum | Not applicable |
Gender | Both |
Include criteria | H. pylori-positve patients after the 2nd line H. pylori eradication therapy or penicillin-allergic patients |
Exclude criteria | 1. Patients with allergy for quinolones 2. Patients with allergy for PPIs 3. Patients with severe liver injury and/or severe renal damage 4. Pregnancy or possible pregnancy 5. Patients who were recognized as inappropriate for entry |
Related Information
Primary Sponsor | Hirata Kenro |
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Secondary Sponsor | |
Source(s) of Monetary Support | |
Secondary ID(s) | UMIN000022236 |
Contact
Public contact | |
Name | Kenro Hirata |
Address | 35 Shinanomachi Shinjuku-ku Tokyo Tokyo Japan 160-8582 |
Telephone | +81-3-5363-3790 |
Kenro916@gmail.com | |
Affiliation | Keio University Hospital |
Scientific contact | |
Name | Kenro Hirata |
Address | 35 Shinanomachi Shinjuku-ku Tokyo Tokyo Japan 160-8582 |
Telephone | +81-3-5363-3790 |
Kenro916@gmail.com | |
Affiliation | Keio University Hospital |