Trial · NCT03219723

Drug Use Surveillance of Takecab for "Supplement to Helicobacter Pylori Eradication"

NCT03219723, Completed, Takeda; results first posted 2019-03-22

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Drug Use Surveillance of Takecab for "Supplement to Helicobacter Pylori Eradication". Trials, record NCT03219723. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03219723

On this page

Trial

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

Title: Drug Use Surveillance of Takecab for "Supplement to Helicobacter Pylori Eradication"
NCT number: NCT03219723
Status: Completed
Enrollment: 560 participants, actual
Lead sponsor: Takeda
Conditions: Gastric/Duodenal Ulcer, Gastric MALT Lymphoma, Idiopathic Thrombocytopenic Purpura, or H. Pylori Gastritis, and Other
Interventions: Vonoprazan, Amoxicillin hydrate, Clarithromycin, Metronidazole
First posted: 2017-07-17
Last updated: 2019-03-22
Results first posted: 2019-03-22

Source ClinicalTrials.gov

Registered outcomes2

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

List	Outcome	Time frame	Description
Primary	Percentage of Participants Who Had One or More Adverse Drug Reactions	Up to 7 days and 2 months	Adverse drug reaction refers to adverse events related to administered drug. Timeframe was defined as duration of triple therapy (7 days) and up to the time of determination of H. pylori eradication after triple therapy (approximately 2 months as maximum duration).
Secondary	H. Pylori Eradication Rate	7 days + 2 months	In participants who were determined as achieving H. pylori eradication, the percentage of participants negative for H. pylori (eradication rates) was tabulated by first-line eradication and second-line eradication. Timeframe was defined as duration of triple therapy (7 days) and up to the time of determination of H. pylori eradication after triple therapy (approximately 2 months as maximum duration).

Source ClinicalTrials.gov

Outcomes2

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Percentage of Participants Who Had One or More Adverse Drug Reactions	Up to 7 days and 2 months	Safety Analysis Set; The safety analysis set was defined as all participants who completed the study.	Percentage of Participants	NUMBER
SECONDARY	H. Pylori Eradication Rate	7 days + 2 months	Efficacy assessment population; The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available.	Percent	NUMBER

Source ClinicalTrials.gov

Results by group3

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

Outcome	Group	Category	Value	Spread	Units
Percentage of Participants Who Had One or More Adverse Drug Reactions	Vonoprazan 20 mg		3.09		Percentage of Participants
H. Pylori Eradication Rate	Vonoprazan 20 mg	First-Line Eradication	91.24	95% Confidence Interval 88.30 to 93.64	Percent
H. Pylori Eradication Rate	Vonoprazan 20 mg	Second-Line Eradication	95.45	95% Confidence Interval 84.53 to 99.44	Percent

Source ClinicalTrials.gov

Participant flow3

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Vonoprazan 20 mg	560
Overall Study	COMPLETED	Vonoprazan 20 mg	550
Overall Study	NOT COMPLETED	Vonoprazan 20 mg	10

Source ClinicalTrials.gov

Adverse events20

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	Influenza	Infections and infestations	Vonoprazan 20 mg	1	550
other	Dizziness	Nervous system disorders	Vonoprazan 20 mg	1	550
other	Dysgeusia	Nervous system disorders	Vonoprazan 20 mg	3	550
other	Hypogeusia	Nervous system disorders	Vonoprazan 20 mg	1	550
other	Abdominal discomfort	Gastrointestinal disorders	Vonoprazan 20 mg	1	550
other	Abdominal distension	Gastrointestinal disorders	Vonoprazan 20 mg	1	550
other	Constipation	Gastrointestinal disorders	Vonoprazan 20 mg	1	550
other	Diarrhoea	Gastrointestinal disorders	Vonoprazan 20 mg	4	550
other	Faeces hard	Gastrointestinal disorders	Vonoprazan 20 mg	1	550
other	Ileus	Gastrointestinal disorders	Vonoprazan 20 mg	1	550

1 to 10 of 20Source ClinicalTrials.gov

See all 20 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Vonoprazan 20 mg	0	550
Total, other adverse events	Vonoprazan 20 mg	22	550
Total, serious adverse events	Vonoprazan 20 mg	0	550

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

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/NCT03219723

GET https://conductscience.org/api/trials/v1/NCT03219723/registered

API reference For AI assistants