Clinical trial NCT03219723: Drug Use Surveillance of Takecab for "Supplement to Helicobacter Pylori Eradication"
Official title: Drug Use Surveillance of Takecab Tablets "Supplement to Helicobacter Pylori Eradication"
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastric/Duodenal Ulcer, Gastric MALT Lymphoma, Idiopathic Thrombocytopenic Purpura, or H. Pylori Gastritis, and Other
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2017-07-17
Enrollment: 560
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population will consist of participants receiving first-line eradication and second-line eradication including Takecab tablets (triple therapy) in the routine medical care.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants Who Had One or More Adverse Drug Reactions
timeFrame: Up to 7 days and 2 months
Secondary outcomes:
measure: H. Pylori Eradication Rate
timeFrame: 7 days + 2 months
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Takeda Selected Site
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: