Safety of Vonoprazan-Amoxicillin Dual Therapy Versus Concomitant Quadruple Therapy for H. Pylori Eradication

NCT07924098, Phase 4, Recruiting, Ignacio Moratorio

Trial 10

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Field	Value	Source
Title	Safety of Vonoprazan-Amoxicillin Dual Therapy Versus Concomitant Quadruple Therapy for H. Pylori Eradication	ClinicalTrials.gov
NCT number	NCT07924098	ClinicalTrials.gov
Status	Recruiting	ClinicalTrials.gov
Phases	Phase 4	ClinicalTrials.gov
Enrollment	100 participants, estimated	ClinicalTrials.gov
Lead sponsor	Ignacio Moratorio	ClinicalTrials.gov
Conditions	HELICOBACTER PYLORI INFECTIONS	ClinicalTrials.gov
Interventions	Vonoprazan (Reference), Amoxicillin, Metronidazole, Clarithromycin 500 mg, Omeprazole	ClinicalTrials.gov
First posted	2026-11-09	ClinicalTrials.gov
Last updated	2026-11-09	ClinicalTrials.gov

Registered outcomes 8

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description	Source
Primary	Maximum severity of adverse events per participant	From first dose of study medication through the end of the 14-day treatment course	Highest severity grade reached by each participant across all solicited symptoms (nausea, vomiting, diarrhoea, abdominal pain, dysgeusia, dyspepsia, reflux, anorexia, asthenia, skin rash and other), recorded as a four-category ordinal variable: absent; mild (does not affect quality of life and requires no treatment); moderate (requires pharmacological treatment); severe (requires hospital consultation). Severity grading follows the logic of CTCAE v5.0. Data are collected with a self-administered Adherence and Adverse Events Questionnaire completed by the participant at the end of the treatment course and returned to the treating physician at the post-treatment visit. Each participant contributes a single observation; when more than one symptom is reported, the highest severity category reached in any of them is assigned. Arms are compared by ordinal logistic regression with proportional-odds assumption testing.	ClinicalTrials.gov
Secondary	Proportion of participants with at least one adverse event	From first dose of study medication through the end of the 14-day treatment course	Proportion of participants reporting at least one adverse event of any severity on the self-administered Adherence and Adverse Events Questionnaire. Reported as a risk difference with Newcombe 95% confidence interval and as a relative risk.	ClinicalTrials.gov
Secondary	Helicobacter pylori eradication rate	At least 45 days after first dose of study medication	Proportion of participants with a negative post-treatment test, performed at least 45 days after the first dose of study medication. Accepted confirmation methods are monoclonal stool antigen test, gastric histology, rapid urease test or urea breath test, as available at each centre; serology is not accepted for post-treatment confirmation. Participants are asked to withhold proton pump inhibitors and potassium-competitive acid blockers until the test is performed. Reported as a percentage with 95% confidence interval. The intention-to-treat analysis is primary for this outcome, with participants lacking a post-treatment test counted as treatment failures; the per-protocol analysis is reported as a sensitivity analysis.	ClinicalTrials.gov
Secondary	Treatment adherence	From first dose of study medication through the end of the 14-day treatment course	Proportion of participants with good adherence, defined as completion of 80% or more of the assigned 14-day regimen (11 days or more) at the prescribed dose and frequency, assessed by self-administered questionnaire. Reported as a risk difference and relative risk with 95% confidence intervals.	ClinicalTrials.gov
Secondary	Number of distinct adverse symptoms per participant	From first dose of study medication through the end of the 14-day treatment course	Count of distinct symptoms reported by each participant on the Adherence and Adverse Events Questionnaire, analysed with a Poisson or negative binomial model according to the observed dispersion.	ClinicalTrials.gov
Secondary	Total duration of adverse events	From first dose of study medication through the end of the 14-day treatment course	Total number of days with adverse events reported by each participant on the Adherence and Adverse Events Questionnaire.	ClinicalTrials.gov
Secondary	Treatment discontinuation attributed to an adverse event	From first dose of study medication through the end of the 14-day treatment course	Proportion of participants who discontinued the assigned regimen before completing 14 days for a reason attributed to an adverse event. The reason recorded in free text by the treating physician is classified by a non-investigator, blinded to arm allocation, into one of four mutually exclusive categories (discontinuation attributed to an adverse event; participant decision not attributed to an adverse event; forgetfulness or difficulty complying; reason not recorded). Reported as a risk difference with 95% confidence interval, disaggregated by arm.	ClinicalTrials.gov
Other	Incidence of each individual adverse event	From first dose of study medication through the end of the 14-day treatment course	Proportion of participants reporting each individual symptom (nausea, vomiting, diarrhoea, abdominal pain, dysgeusia, dyspepsia, reflux, anorexia, asthenia, skin rash and other), reported by arm with 95% confidence intervals and without adjustment for multiple comparisons. These analyses are exploratory and do not support confirmatory inference.	ClinicalTrials.gov

Outcomes 0

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as	Source

Results by group 0

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units	Source

Participant flow 0

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants	Units counted	Source

Adverse events 0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events	Source

Adverse event totals 0

The totals the trial posted for each group.

Total	Group	Affected	At risk	Source

Papers 0

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source

Grants 0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years	Source

Trial comparisons 0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source

Tests 0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

Test	Named as	Source

Source 5

Field	Value	Source
Release	trials-2026-11-12-0.4.0	ClinicalTrials.gov
Release manifest SHA-256	0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4	ClinicalTrials.gov
Registry capture	2026-11-12	ClinicalTrials.gov
Results copy, AACT	2026-03-23	ClinicalTrials.gov
NIH clinical studies file	2026-11-13	ClinicalTrials.gov

The same record as JSON

Release trials-2026-11-12-0.4.0

ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)