Trial · NCT04198363

A Study to Evaluate the Efficacy and Safety of Bismuth-Containing Quadruple Therapy With Oral Vonoprazan (TAK-438) 20 mg Compared to Esomeprazole 20 mg Twice Daily in Paticipants With Helicobacter Pylori Infection

NCT04198363, Phase 3, Completed, Takeda; results first posted 2023-09-07

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study to Evaluate the Efficacy and Safety of Bismuth-Containing Quadruple Therapy With Oral Vonoprazan (TAK-438) 20 mg Compared to Esomeprazole 20 mg Twice Daily in Paticipants With Helicobacter Pylori Infection. Trials, record NCT04198363. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04198363

On this page

Trial

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

Title: A Study to Evaluate the Efficacy and Safety of Bismuth-Containing Quadruple Therapy With Oral Vonoprazan (TAK-438) 20 mg Compared to Esomeprazole 20 mg Twice Daily in Paticipants With Helicobacter Pylori Infection
NCT number: NCT04198363
Status: Completed
Phases: Phase 3
Enrollment: 510 participants, actual
Lead sponsor: Takeda
Conditions: Helicobacter Pylori
Interventions: Vonoprazan, Amoxicillin, Clarithromycin, Bismuth Potassium citrate, Esomeprazole
First posted: 2019-12-13
Last updated: 2023-09-07
Results first posted: 2023-09-07

Source ClinicalTrials.gov

Registered outcomes1

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

List	Outcome	Time frame	Description
Primary	Percentage of Helicobacter Pylori Positive (HP+) Participants With Successful HP Eradication at Week 4 Post-Treatment	Week 4 post-treatment	HP infection status was determined by \^13C Urea Breath Test (\^13C-UBT). The urea breath test is used to detect infection with HP, a bacteria associated with stomach ulcers, by testing individual breath samples in a central laboratory. The percentages are rounded off to report the nearest ten.

Source ClinicalTrials.gov

Outcomes1

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Percentage of Helicobacter Pylori Positive (HP+) Participants With Successful HP Eradication at Week 4 Post-Treatment	Week 4 post-treatment	FAS included all randomized participants who received at least 1 dose of the study drug. Overall number analyzed are the number of participants who had available HP eradication status determined by \^13C-UBT at Week 4 post-treatment.	percentage of participants	NUMBER

Source ClinicalTrials.gov

Results by group2

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

Outcome	Group	Category	Value	Spread	Units
Percentage of Helicobacter Pylori Positive (HP+) Participants With Successful HP Eradication at Week 4 Post-Treatment	Vonoprazan 20 mg		86.8		percentage of participants
Percentage of Helicobacter Pylori Positive (HP+) Participants With Successful HP Eradication at Week 4 Post-Treatment	Esomeprazole 20 mg		86.7		percentage of participants

Source ClinicalTrials.gov

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Vonoprazan 20 mg	256
Overall Study	STARTED	Esomeprazole 20 mg	254
Overall Study	COMPLETED	Vonoprazan 20 mg	254
Overall Study	COMPLETED	Esomeprazole 20 mg	252
Overall Study	NOT COMPLETED	Vonoprazan 20 mg	2
Overall Study	NOT COMPLETED	Esomeprazole 20 mg	2

Source ClinicalTrials.gov

Adverse events26

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
other	Faeces discoloured	Gastrointestinal disorders	Vonoprazan 20 mg	13	256
other	Faeces discoloured	Gastrointestinal disorders	Esomeprazole 20 mg	8	254
other	Hepatic function abnormal	Hepatobiliary disorders	Vonoprazan 20 mg	17	256
other	Hepatic function abnormal	Hepatobiliary disorders	Esomeprazole 20 mg	9	254
other	Protein urine present	Investigations	Vonoprazan 20 mg	18	256
other	Protein urine present	Investigations	Esomeprazole 20 mg	15	254
other	Dysgeusia	Nervous system disorders	Vonoprazan 20 mg	83	256
other	Dysgeusia	Nervous system disorders	Esomeprazole 20 mg	74	254
serious	Arrhythmia supraventricular	Cardiac disorders	Vonoprazan 20 mg	1	256
serious	Arrhythmia supraventricular	Cardiac disorders	Esomeprazole 20 mg	0	254

1 to 10 of 26Source ClinicalTrials.gov

See all 26 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Vonoprazan 20 mg	0	256
Total, all-cause mortality	Esomeprazole 20 mg	0	254
Total, other adverse events	Vonoprazan 20 mg	110	256
Total, other adverse events	Esomeprazole 20 mg	91	254
Total, serious adverse events	Vonoprazan 20 mg	3	256
Total, serious adverse events	Esomeprazole 20 mg	5	254

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
39965795	DERIVED

Source 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 comparisons2

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

Comparison	Source
Vonoprazan 20 mg vs Esomeprazole 20 mg: deaths from any cause	Trial comparisons
Vonoprazan 20 mg vs Esomeprazole 20 mg: serious adverse events	Trial comparisons

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/NCT04198363

GET https://conductscience.org/api/trials/v1/NCT04198363/events?page=2

API reference For AI assistants