Gastric/Duodenal Ulcer, Gastric MALT Lymphoma, Idiopathic Thrombocytopenic Purpura, or H. Pylori Gastritis, and Other Clinical Trial
Official title:
Drug Use Surveillance of Takecab Tablets "Supplement to Helicobacter Pylori Eradication"
The purpose of this study is to evaluate the safety and efficacy on participants receiving first-line eradication and second-line eradication including vonoprazan (Takecab) tablets (triple therapy) in the routine clinical setting.
The drug being tested in this study is called Vonoprazan (Takecab). Vonoprazan is being
tested to treat people who have gastric ulcer, duodenal ulcer, gastric mucosa-associated
lymphoid tissue (MALT) lymphoma, idiopathic thrombocytopenic purpura, stomach following
endoscopic treatment of early gastric cancer, or H. pylori gastritis. This study will look at
the presence or absence of new concerns regarding the safety of triple therapy with
Vonoprazan tablets, amoxicillin, and clarithromycin (first-line eradication) and triple
therapy with Vonoprazan tablets, amoxicillin, and metronidazole (second-line eradication) for
supplemental Helicobacter pylori (H. pylori) eradication in the routine clinical setting. The
study will enroll approximately 500 patients.
First-line eradication
- Vonoprazan 20 mg / Proton pump inhibitor
- Amoxicillin hydrate 750 mg
- Clarithromycin 200 mg
If H. pylori eradication with a three-drug regimen comprising vonoprazan or proton pump
inhibitor + amoxicillin hydrate + clarithromycin has been unsuccessful.
Second-line eradication
- Vonoprazan 20 mg
- Amoxicillin hydrate 750 mg
- metronidazole 250 mg
This multi-center trial will be conducted in Japan.
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