Clinical trial · Observational
Drug Use Surveillance of Takecab for "Supplement to Helicobacter Pylori Eradication"
Drug Use Surveillance of Takecab Tablets "Supplement to Helicobacter Pylori Eradication"
NCT03219723CI-TRIAL-00037745completedResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric/Duodenal Ulcer, Gastric MALT Lymphoma, Idiopathic Thrombocytopenic Purpura, or H. Pylori Gastritis, and Other | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Amoxicillin hydrate | Drug | — | UNRESOLVED |
| Clarithromycin | Drug | — | UNRESOLVED |
| Metronidazole | Drug | — | UNRESOLVED |
| Vonoprazan | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Vonoprazan 20 mg
- description
- For adults, the following three-drug regimen will be administered orally at the same time twice daily for 7 days: 20 mg dose of vonoprazan, 750 mg (potency) dose of amoxicillin hydrate, and 200 mg (potency) dose of clarithromycin. The dose of clarithromycin may be increased as clinically warranted. However, dosage should not exceed 400 mg (potency)/dose twice daily. If H. pylori eradication with a three-drug regimen comprising vonoprazan or proton pump inhibitor + amoxicillin hydrate + clarithromycin has been unsuccessful, as an alternative treatment, the following three drugs will be administered orally twice daily for 7 days to adults: 20 mg dose of vonoprazan, 750 mg (potency) dose of amoxicillin hydrate, and 250 mg dose of metronidazole. Participants will receive interventions as part of routine medical care.
- interventionNames
- Drug: Vonoprazan
- Drug: Amoxicillin hydrate
- Drug: Clarithromycin
- Drug: Metronidazole
Primary outcomes (1)
- measure
- Percentage of Participants Who Had One or More Adverse Drug Reactions
- timeFrame
- Up to 7 days and 2 months
- description
- 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).
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.