Vonoprazan-Based Triple Therapy in Comparison With Extended Sequential Therapy
Study Details
Study Description
Brief Summary
This study aims to compare the efficacy of the current standard first-line anti-helicobacter pylori regimen, extended proton pump inhibitor-based sequential therapy, with that of vonoprazan-based triple therapy, through a randomized controlled trial.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Detailed Description
Helicobacter pylori infection is a well-established risk factor for peptic ulcer disease and gastric cancer. It's now a consensus of experts that H.pylori infection should be treated once it is recognized. Extended proton pump inhibitor (PPI)-based sequential therapy as one of the most commonly used first-line regimens provides a satisfactory eradication rate of 90.7% (95% CI, 87.4% - 94.0%). Nevertheless, its complexity of the "sequential" usage is sometimes confusing to the patients and may lead to treatment failure. The emerging new regimen - vonoprazan-based triple therapy, on the other hand, is another appealing choice with simplicity, short treatment duration, and low pill burden. However, there's still no evidence regarding the use of vonoprazan-based triple therapy with high-dose amoxicillin (1000mg twice daily) as the first-line regimen. This study aimed to compare the efficacy of the current standard first-line regimen, sequential therapy, with that of vonoprazan-based triple therapy with high-dose Amoxicillin.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Vonoprazan-based triple therapy group Including patients receiving vonoprazan-based triple therapy (vonoprazan 20mg + amoxicillin 1000 mg + clarithromycin 500 mg twice daily for seven days) |
Drug: Vonoprazan-based triple therapy
vonoprazan 20mg+amoxicillin 1000 mg + clarithromycin 500 mg twice daily for seven days
Other Names:
|
| Active Comparator: Extended sequential therapy group Including patients receiving extended sequential therapy (lansoprazole 30mg + amoxicillin 1000mg twice daily for 7 days, followed by lansoprazole 30mg + clarithromycin 500mg + metronidazole 500mg twice daily for 7 days) |
Drug: Extended sequential therapy
Lansoprazole 30mg + amoxicillin 1000mg twice daily for 7 days, followed by lansoprazole 30mg + clarithromycin 500mg + metronidazole 500mg twice daily for 7 days
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Eradication rate of helicobacter pylori [Assessed at least 6 weeks after the therapy]
Assessed by urea breath test
Secondary Outcome Measures
- Adverse effects of the drugs [After patients completed the therapy (For VAC-7 group: 1 week after the therapy; For S-14 group: 2 weeks after the therapy)]
Self-reported adverse effects by patients through a questionnaire.
- Compliance [After patients completed the therapy ((For VAC-7 group: 1 week after the therapy; For S-14 group: 2 weeks after the therapy)]
Self-reported compliance by patients through a questionnaire.
Eligibility Criteria
Criteria
Inclusion Criteria:
- Patients with H.pylori infection who was over 20 years old and agree to participate in the trial will be recruited.
Exclusion Criteria:
-
Who had received helicobacter pylori eradication before
-
Who are known to be allergic to any drug used in this trial
-
Pregnant women
-
Who are refuse to participate in the trial for any reason
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Fu Jen Catholic University Hospital | New Taipei City | Taiwan | 243 |
Sponsors and Collaborators
- Fu Jen Catholic University Hospital
Investigators
- Study Chair: Yu-tse Chiu, MD, Fu Jen Catholic University Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- FJUH110108