At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,046 enrolled
Drug / intervention
Vonoprazan +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3 Randomized Multicenter Study to Evaluate the Efficacy and Safety of Open-Label Dual Therapy With Oral Vonoprazan 20 mg or Double-Blind Triple Therapy With Oral Vonoprazan 20 mg Compared to Double-Blind Triple Therapy With Oral Lansoprazole 30 mg Daily in Patients With Helicobacter Pylori Infection
In Brief
A Phase 3 clinical trial evaluating Vonoprazan, Amoxicillin, and 2 other interventions for Helicobacter Pylori Infection. Completed, enrolled 1,046 participants across 153 sites in 6 countries.
Detailed Summary
To compare the efficacy of Helicobacter pylori (HP) eradication with vonoprazan dual and triple therapy regimens versus lansoprazole triple therapy regimen in participants with HP infection, excluding participants who had a clarithromycin or amoxicillin resistant strain of HP at baseline.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHelicobacter Pylori Infection
CountriesBulgaria, Czechia, Hungary, Poland, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2020202120222023202420252026
First PostedNov 2019
Enrollment StartDec 2019
Primary CompletionMar 2021
Study CompletionMar 2021
TodayJul 2026
First PostedNov 19, 2019
Enrollment StartDec 10, 2019
Primary CompletionMar 10, 2021
Study CompletionMar 18, 2021
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 6.6 years ago
Interventions
Vonoprazandrug
Over-encapsulated tablets administered orally.
Amoxicillindrug
Capsules administered orally.
Clarithromycindrug
Tablets administered orally.
Lansoprazoledrug
Over-encapsulated capsules administered orally.