The following diseases in patients for whom H. pylori will be eradicated with triple therapy: 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
Conditions
Interventions
investigational material(s)
Generic name etc : Takecab tablets + amoxicillin + clarithromycin (first-line eradication) Takecab tablets + amoxicillin + metronidazole (second-line eradication)
INN of in
Sponsors
TAKEDA PHARMACEUTICAL COMPANY LTD.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Participants who meet the following criteria will be included. 1.Participants receiving H. pylori eradication treatment for the first time 2.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
Exclusion criteria: Participants who meet any of the following criteria will not be included. Refer to the Contraindications and Precautions section of the package insert of antimicrobials used in triple therapy. 1.Participants with previous history of hypersensitivity to ingredients in Takecab tablets 2.Participants taking atazanavir sulfate or rilpivirine hydrochloride
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of participants who had one or more adverse drug reactions Adverse drug reaction refers to adverse events related to administered drug. Timeframe is 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). Timeframe; Up to 7days and 2 months | — |
Secondary
| Measure | Time frame |
|---|---|
| H. pylori eradication rate In patients who are determined as achieving H. pylori eradication, the proportion of patients negative for H. pylori (eradication rates) will be tabulated by first-line eradication and second-line eradication. Timeframe is 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). Timeframe; 7days + 2 months | — |
Outcome results
None listed