Trial · NCT03214094
Special Drug Use Surveillance of Vonoprazan for "Prevention of Recurrence of Gastric/Duodenal Ulcer in Patients Receiving Low-dose Aspirin: Long-term Use"
NCT03214094, Completed, Takeda; results first posted 2020-03-11
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Special Drug Use Surveillance of Vonoprazan for "Prevention of Recurrence of Gastric/Duodenal Ulcer in Patients Receiving Low-dose Aspirin: Long-term Use". Trials, record NCT03214094. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03214094
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Special Drug Use Surveillance of Vonoprazan for "Prevention of Recurrence of Gastric/Duodenal Ulcer in Patients Receiving Low-dose Aspirin: Long-term Use"
- NCT number
- NCT03214094
- Status
- Completed
- Enrollment
- 1,119 participants, actual
- Lead sponsor
- Takeda
- Conditions
- Gastric or Duodenal Ulcers
- Interventions
- Vonoprazan
- First posted
- 2017-07-11
- Last updated
- 2020-03-11
- Results first posted
- 2020-03-11
Source ClinicalTrials.gov
Registered outcomes5
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 12 months | An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Adverse drug reaction refers to AE related to administered drug. |
| Secondary | Percentage of Participants With Gastric Ulcers After the Start of Administration of Vonoprazan Tablets | Up to 12 months | Reported data were percentage of participants who experienced an onset of gastric ulcers after the start of administration of vonoprazan tablets. |
| Secondary | Percentage of Participants With Duodenal Ulcers After the Start of Administration of Vonoprazan Tablets | Up to 12 months | Reported data were percentage of participants who experienced an onset of duodenal ulcers after the start of administration of vonoprazan tablets. |
| Secondary | Percentage of Participants With Hemorrhagic Lesions on Stomach After the Start of Administration of Vonoprazan Tablets | Up to 12 months | Reported data were percentage of participants who had hemorrhagic lesions on stomach after the start of administration of vonoprazan tablets. |
| Secondary | Percentage of Participants With Hemorrhagic Lesions on Duodenum After the Start of Administration of Vonoprazan Tablets | Up to 12 months | Reported data were percentage of participants who had hemorrhagic lesions on duodenum after the start of administration of vonoprazan tablets. |
Source ClinicalTrials.gov
Outcomes5
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 12 months | Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With Gastric Ulcers After the Start of Administration of Vonoprazan Tablets | Up to 12 months | Efficacy assessment population, The efficacy assessment population was defined as participants who completed the survey and had efficacy data at baseline and post-baseline time points available. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With Duodenal Ulcers After the Start of Administration of Vonoprazan Tablets | Up to 12 months | Efficacy assessment population, The efficacy assessment population was defined as participants who completed the survey and had efficacy data at baseline and post-baseline time points available. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With Hemorrhagic Lesions on Stomach After the Start of Administration of Vonoprazan Tablets | Up to 12 months | Efficacy assessment population, The efficacy assessment population was defined as participants who completed the survey and had efficacy data at baseline and post-baseline time points available. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With Hemorrhagic Lesions on Duodenum After the Start of Administration of Vonoprazan Tablets | Up to 12 months | Efficacy assessment population, The efficacy assessment population was defined as participants who completed the survey and had efficacy data at baseline and post-baseline time points available. | Percentage of Participants | NUMBER |
Source ClinicalTrials.gov
Results by group5
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 10 mg | 1.79 | Percentage of Participants | ||
| Percentage of Participants With Gastric Ulcers After the Start of Administration of Vonoprazan Tablets | Vonoprazan 10 mg | 0.67 | Percentage of Participants | ||
| Percentage of Participants With Duodenal Ulcers After the Start of Administration of Vonoprazan Tablets | Vonoprazan 10 mg | 0.19 | Percentage of Participants | ||
| Percentage of Participants With Hemorrhagic Lesions on Stomach After the Start of Administration of Vonoprazan Tablets | Vonoprazan 10 mg | 0.19 | Percentage of Participants | ||
| Percentage of Participants With Hemorrhagic Lesions on Duodenum After the Start of Administration of Vonoprazan Tablets | Vonoprazan 10 mg | 0.00 | Percentage of Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Vonoprazan 10 mg | 1,119 | |
| Overall Study | COMPLETED | Vonoprazan 10 mg | 1,059 | |
| Overall Study | NOT COMPLETED | Vonoprazan 10 mg | 60 |
Source ClinicalTrials.gov
Adverse events45
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 | Drug eruption | Skin and subcutaneous tissue disorders | Vonoprazan 10 mg | 4 | 1,059 | |
| serious | Endocarditis | Infections and infestations | Vonoprazan 10 mg | 1 | 1,059 | |
| serious | Gangrene | Infections and infestations | Vonoprazan 10 mg | 1 | 1,059 | |
| serious | Pneumonia | Infections and infestations | Vonoprazan 10 mg | 3 | 1,059 | |
| serious | Sepsis | Infections and infestations | Vonoprazan 10 mg | 2 | 1,059 | |
| serious | Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Vonoprazan 10 mg | 1 | 1,059 | |
| serious | Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Vonoprazan 10 mg | 2 | 1,059 | |
| serious | Lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Vonoprazan 10 mg | 1 | 1,059 | |
| serious | Rectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Vonoprazan 10 mg | 1 | 1,059 | |
| serious | Renal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Vonoprazan 10 mg | 1 | 1,059 |
1 to 10 of 45Source ClinicalTrials.gov
See all 45 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Vonoprazan 10 mg | 9 | 1,059 |
| Total, other adverse events | Vonoprazan 10 mg | 4 | 1,059 |
| Total, serious adverse events | Vonoprazan 10 mg | 50 | 1,059 |
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.
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/NCT03214094
GET https://conductscience.org/api/trials/v1/NCT03214094/events?page=2