Trial · NCT04167670

Efficacy and Safety of Vonoprazan Compared to Lansoprazole in Participants With Helicobacter Pylori Infection

NCT04167670, Phase 3, Completed, Phathom Pharmaceuticals, Inc.; results first posted 2022-04-05

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Efficacy and Safety of Vonoprazan Compared to Lansoprazole in Participants With Helicobacter Pylori Infection. Trials, record NCT04167670. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04167670

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Trial

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

Title: Efficacy and Safety of Vonoprazan Compared to Lansoprazole in Participants With Helicobacter Pylori Infection
NCT number: NCT04167670
Status: Completed
Phases: Phase 3
Enrollment: 1,046 participants, actual
Lead sponsor: Phathom Pharmaceuticals, Inc.
Conditions: Helicobacter Pylori Infection
Interventions: Vonoprazan, Amoxicillin, Clarithromycin, Lansoprazole
First posted: 2019-11-19
Last updated: 2022-04-05
Other registries' IDs: eudract:2019-002668-28
Results first posted: 2022-04-05

Source ClinicalTrials.gov

Registered outcomes3

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

List	Outcome	Time frame	Description
Primary	Percentage of Participants With Successful Helicobacter Pylori (H Pylori) Eradication in Participants Without a Clarithromycin- or Amoxicillin-resistant Strain of H Pylori at Baseline	Baseline to 4 weeks after the last dose of study drugs (maximum duration of treatment was 2 weeks)	H pylori eradication was determined by the \^13C-UBT test.
Secondary	Percentage of Participants With Successful Helicobacter Pylori (H Pylori) Eradication in Participants With a Clarithromycin-resistant Strain of H Pylori at Baseline	Baseline to 4 weeks after the last dose of study drugs (maximum duration of treatment was 2 weeks)	H pylori eradication was determined by the \^13C-UBT test.
Secondary	Percentage of All Participants With Successful Helicobacter Pylori (H Pylori) Eradication	Baseline to 4 weeks after the last dose of study drugs (maximum duration of treatment was 2 weeks)	H pylori eradication was determined by the \^13C-UBT test.

Source ClinicalTrials.gov

Outcomes3

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Percentage of Participants With Successful Helicobacter Pylori (H Pylori) Eradication in Participants Without a Clarithromycin- or Amoxicillin-resistant Strain of H Pylori at Baseline	Baseline to 4 weeks after the last dose of study drugs (maximum duration of treatment was 2 weeks)	Modified Intent-to-Treat Primary (MITTp) Analysis Set - All participants randomized into the study who had a H pylori infection documented by \^13C-UBT and biopsy (ie, culture or histology) at baseline and did not have a clarithromycin- or amoxicillin-resistant strain of H pylori at baseline.	percentage of participants	NUMBER
SECONDARY	Percentage of Participants With Successful Helicobacter Pylori (H Pylori) Eradication in Participants With a Clarithromycin-resistant Strain of H Pylori at Baseline	Baseline to 4 weeks after the last dose of study drugs (maximum duration of treatment was 2 weeks)	All participants randomized into the study who had H pylori infection documented by \^13C-UBT and biopsy (ie, culture or histology) at baseline and had a clarithromycin-resistant strain of H pylori at baseline.	percentage of participants	NUMBER
SECONDARY	Percentage of All Participants With Successful Helicobacter Pylori (H Pylori) Eradication	Baseline to 4 weeks after the last dose of study drugs (maximum duration of treatment was 2 weeks)	Modified Intent-to-Treat (MITT) Analysis Set - All participants randomized into the study who had H pylori infection documented by \^13C-UBT and biopsy (ie, culture or histology) at baseline.	percentage of participants	NUMBER

Source ClinicalTrials.gov

Results by group9

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

Outcome	Group	Value	Units
Percentage of Participants With Successful Helicobacter Pylori (H Pylori) Eradication in Participants Without a Clarithromycin- or Amoxicillin-resistant Strain of H Pylori at Baseline	Vonoprazan Dual Therapy	78.5	percentage of participants
Percentage of Participants With Successful Helicobacter Pylori (H Pylori) Eradication in Participants Without a Clarithromycin- or Amoxicillin-resistant Strain of H Pylori at Baseline	Vonoprazan Triple Therapy	84.7	percentage of participants
Percentage of Participants With Successful Helicobacter Pylori (H Pylori) Eradication in Participants Without a Clarithromycin- or Amoxicillin-resistant Strain of H Pylori at Baseline	Lansoprazole Triple Therapy	78.8	percentage of participants
Percentage of Participants With Successful Helicobacter Pylori (H Pylori) Eradication in Participants With a Clarithromycin-resistant Strain of H Pylori at Baseline	Vonoprazan Dual Therapy	69.6	percentage of participants
Percentage of Participants With Successful Helicobacter Pylori (H Pylori) Eradication in Participants With a Clarithromycin-resistant Strain of H Pylori at Baseline	Vonoprazan Triple Therapy	65.8	percentage of participants
Percentage of Participants With Successful Helicobacter Pylori (H Pylori) Eradication in Participants With a Clarithromycin-resistant Strain of H Pylori at Baseline	Lansoprazole Triple Therapy	31.9	percentage of participants
Percentage of All Participants With Successful Helicobacter Pylori (H Pylori) Eradication	Vonoprazan Dual Therapy	77.2	percentage of participants
Percentage of All Participants With Successful Helicobacter Pylori (H Pylori) Eradication	Vonoprazan Triple Therapy	80.8	percentage of participants
Percentage of All Participants With Successful Helicobacter Pylori (H Pylori) Eradication	Lansoprazole Triple Therapy	68.5	percentage of participants

Source ClinicalTrials.gov

Participant flow12

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Vonoprazan Dual Therapy	349
Overall Study	STARTED	Vonoprazan Triple Therapy	349
Overall Study	STARTED	Lansoprazole Triple Therapy	348
Overall Study	Received Study Drugs	Vonoprazan Dual Therapy	348
Overall Study	Received Study Drugs	Vonoprazan Triple Therapy	346
Overall Study	Received Study Drugs	Lansoprazole Triple Therapy	345
Overall Study	COMPLETED	Vonoprazan Dual Therapy	334
Overall Study	COMPLETED	Vonoprazan Triple Therapy	331
Overall Study	COMPLETED	Lansoprazole Triple Therapy	334
Overall Study	NOT COMPLETED	Vonoprazan Dual Therapy	15

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events48

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
other	Diarrhoea	Gastrointestinal disorders	Vonoprazan Dual Therapy	18	348	18
other	Diarrhoea	Gastrointestinal disorders	Vonoprazan Triple Therapy	14	346	14
other	Diarrhoea	Gastrointestinal disorders	Lansoprazole Triple Therapy	33	345	33
other	Dysgeusia	Nervous system disorders	Vonoprazan Dual Therapy	2	348	2
other	Dysgeusia	Nervous system disorders	Vonoprazan Triple Therapy	15	346	15
other	Dysgeusia	Nervous system disorders	Lansoprazole Triple Therapy	21	345	21
serious	Atrial fibrillation	Cardiac disorders	Vonoprazan Dual Therapy	1	348	1
serious	Atrial fibrillation	Cardiac disorders	Vonoprazan Triple Therapy	0	346	0
serious	Atrial fibrillation	Cardiac disorders	Lansoprazole Triple Therapy	0	345	0
serious	Cardiac arrest	Cardiac disorders	Vonoprazan Dual Therapy	0	348	0

1 to 10 of 48Source ClinicalTrials.gov

See all 48 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Vonoprazan Dual Therapy	0	348
Total, all-cause mortality	Vonoprazan Triple Therapy	2	346
Total, all-cause mortality	Lansoprazole Triple Therapy	1	345
Total, other adverse events	Vonoprazan Dual Therapy	20	348
Total, other adverse events	Vonoprazan Triple Therapy	27	346
Total, other adverse events	Lansoprazole Triple Therapy	48	345
Total, serious adverse events	Vonoprazan Dual Therapy	5	348
Total, serious adverse events	Vonoprazan Triple Therapy	6	346
Total, serious adverse events	Lansoprazole Triple Therapy	3	345

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
35679950	DERIVED	PubMed
36191284	DERIVED	PubMed

Grants0

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.

None in this release.

Trial comparisons0

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

None in this release.

Tests0

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

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.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.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT04167670

GET https://conductscience.org/api/trials/v1/NCT04167670/events?page=2

API reference For AI assistants