Drug Use Surveillance of Takecab for "Supplement to Helicobacter Pylori Eradication"

N/ACompletedNCT03219723

Takeda560 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

560

Conditions

Gastric/Duodenal Ulcer, Gastric MALT Lymphoma, Idiopathic Thrombocytopenic Purpura, or H. Pylori Gastritis, and Other

Interventions

VonoprazanDRUG

Vonoprazan tablets

Amoxicillin hydrateDRUG

Amoxicillin hydrate (potency)

ClarithromycinDRUG

Clarithromycin (potency)

Metronidazole

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (1)

Takeda Selected Site

Tokyo, Japan

Outcomes

Primary Outcomes

Percentage of Participants Who Had One or More Adverse Drug Reactions

Adverse drug reaction refers to adverse events related to administered drug. Timeframe was defined as duration of triple therapy (7 days) and up to the time of determination of H. pylori eradication after triple therapy (approximately 2 months as maximum duration).

Time frame: Up to 7 days and 2 months

Secondary Outcomes

H. Pylori Eradication Rate

In participants who were determined as achieving H. pylori eradication, the percentage of participants negative for H. pylori (eradication rates) was tabulated by first-line eradication and second-line eradication. Timeframe was defined as duration of triple therapy (7 days) and up to the time of determination of H. pylori eradication after triple therapy (approximately 2 months as maximum duration).

Time frame: 7 days + 2 months

Data from ClinicalTrials.gov

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