Trial · NCT03214952
Drug Use Surveillance of Vonoprazan for "Gastric Ulcer, Duodenal Ulcer, and Reflux Esophagitis"
NCT03214952, Completed, Takeda; results first posted 2019-12-12
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Drug Use Surveillance of Vonoprazan for "Gastric Ulcer, Duodenal Ulcer, and Reflux Esophagitis". Trials, record NCT03214952. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03214952
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Drug Use Surveillance of Vonoprazan for "Gastric Ulcer, Duodenal Ulcer, and Reflux Esophagitis"
- NCT number
- NCT03214952
- Status
- Completed
- Enrollment
- 3,183 participants, actual
- Lead sponsor
- Takeda
- Conditions
- Gastric Ulcer, Duodenal Ulcer, and Reflux Esophagitis
- Interventions
- Vonoprazan
- First posted
- 2017-07-12
- Last updated
- 2019-12-12
- Results first posted
- 2019-12-12
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Gastric Ulcer Who Had One or More Adverse Drug Reactions | Up to 8 weeks | 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 the administered drug. |
| Primary | Percentage of Participants With Duodenal Ulcer Who Had One or More Adverse Drug Reactions | Up to 6 weeks | An 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 the administered drug. |
| Primary | Percentage of Participants With Reflux Esophagitis Who Had One or More Adverse Drug Reactions | Up to 8 weeks | An 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 the administered drug. |
| Secondary | Endoscopic Cure Rate in Participants With Gastric Ulcer | Up to 8 weeks | Endoscopic cure rate was defined as a percentage of participants treated for gastric ulcer who classified as Scarring stage at the end of survey per Sakita-Miwa Classification. Endoscopic findings of ulcer were classified per Sakita-Miwa Classification as follows; Active stage: A1 and A2, Healing stage: H1 and H2, Scarring stage: S1 and S2. |
| Secondary | Endoscopic Cure Rate in Participants With Duodenal Ulcer | Up to 6 weeks | Endoscopic cure rate was defined as a percentage of participants treated for duodenal ulcer who classified as Scarring stage at the end of survey per Sakita-Miwa Classification. Endoscopic findings of ulcer were classified per Sakita-Miwa Classification as follows; Active stage: A1 and A2, Healing stage: H1 and H2, Scarring stage: S1 and S2. |
| Secondary | Endoscopic Cure Rate in Participants With Reflux Esophagitis | Up to 8 weeks | Endoscopic cure rate was defined as a percentage of participants who treated for reflux esophagitis and met the criteria of Grade N or M in the modified Los Angeles (LA) classification at the end of survey. Grade N: normal mucosa; Grade M: minimal changes to the mucosa, such as erythema and/or whitish turbidity. |
| Secondary | Percentage of Participants With Gastric Ulcer Whose Subjective Symptoms Improved | Baseline and at the end of the survey (up to 8 weeks) | Percentage of participants who treated for gastric ulcer and whose subjective symptoms, including heartburn, acid reflux, postprandial fullness, early satiation, epigastric pain, epigastric burning, abdominal bloating, nausea/vomiting, belching and anorexia, were improved was reported. Presence or absence and severity of subjective symptoms were graded as asymptomatic, mild (occasionally or slightly symptomatic), moderate (considerably symptomatic), and severe (unendurably symptomatic). Participants with whose subjective symptom was improved by one grade or better were defined as "Improved". |
| Secondary | Percentage of Participants With Duodenal Ulcer Whose Subjective Symptoms Improved | Baseline and at the end of the survey (up to 6 weeks) | Percentage of participants who treated for duodenal ulcer and whose subjective symptoms, including heartburn, acid reflux, postprandial fullness, early satiation, epigastric pain, epigastric burning, abdominal bloating, nausea/vomiting, belching and anorexia, were improved was reported. Presence or absence and severity of subjective symptoms were graded as asymptomatic, mild (occasionally or slightly symptomatic), moderate (considerably symptomatic), and severe (unendurably symptomatic). Participants with whose subjective symptom was improved by one grade or better were defined as "Improved". |
| Secondary | Percentage of Participants With Reflux Esophagitis Whose Subjective Symptoms Improved | Baseline and at the end of the survey (up to 8 weeks) | Percentage of participants who treated for reflux esophagitis and whose subjective symptoms, including heartburn, acid reflux, postprandial fullness, early satiation, epigastric pain, epigastric burning, abdominal bloating, nausea/vomiting, belching and anorexia, were improved was reported. Presence or absence and severity of subjective symptoms were graded as asymptomatic, mild (occasionally or slightly symptomatic), moderate (considerably symptomatic), and severe (unendurably symptomatic). Participants with whose subjective symptom was improved by one grade or better were defined as "Improved". |
Source ClinicalTrials.gov
Outcomes9
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 Gastric Ulcer Who Had One or More Adverse Drug Reactions | Up to 8 weeks | Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey. Participants who treated for gastric ulcer within the Safety Analysis Set were analyzed for this outcome measure. | Percentage of Participants | NUMBER |
| PRIMARY | Percentage of Participants With Duodenal Ulcer Who Had One or More Adverse Drug Reactions | Up to 6 weeks | Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey. Participants who treated for duodenal ulcer within the Safety Analysis Set were analyzed for this outcome measure. | Percentage of Participants | NUMBER |
| PRIMARY | Percentage of Participants With Reflux Esophagitis Who Had One or More Adverse Drug Reactions | Up to 8 weeks | Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey. Participants who treated for reflux esophagitis within the Safety Analysis Set were analyzed for this outcome measure. | Percentage of Participants | NUMBER |
| SECONDARY | Endoscopic Cure Rate in Participants With Gastric Ulcer | Up to 8 weeks | Efficacy assessment population, participants who completed the survey and evaluable for efficacy; Participants who treated for gastric ulcer within Efficacy assessment population and evaluable for endoscopic cure rate were analyzed for this outcome measure. | Percentage of Participants | NUMBER |
| SECONDARY | Endoscopic Cure Rate in Participants With Duodenal Ulcer | Up to 6 weeks | Efficacy assessment population, participants who completed the survey and evaluable for efficacy; Participants who treated for duodenal ulcer within Efficacy assessment population and evaluable for endoscopic cure rate were analyzed for this outcome measure. | Percentage of Participants | NUMBER |
| SECONDARY | Endoscopic Cure Rate in Participants With Reflux Esophagitis | Up to 8 weeks | Efficacy assessment population, participants who completed the survey and evaluable for efficacy; Participants who treated for reflux esophagitis within Efficacy assessment population and evaluable for endoscopic cure rate were analyzed for this outcome measure. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With Gastric Ulcer Whose Subjective Symptoms Improved | Baseline and at the end of the survey (up to 8 weeks) | Efficacy assessment population, participants who completed the survey and evaluable for efficacy; Participants who treated for gastric ulcer within Efficacy assessment population and evaluable for subjective symptoms were analyzed for this outcome measure. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With Duodenal Ulcer Whose Subjective Symptoms Improved | Baseline and at the end of the survey (up to 6 weeks) | Efficacy assessment population, participants who completed the survey and evaluable for efficacy; Participants who treated for duodenal ulcer within Efficacy assessment population and evaluable for subjective symptoms were analyzed for this outcome measure. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With Reflux Esophagitis Whose Subjective Symptoms Improved | Baseline and at the end of the survey (up to 8 weeks) | Efficacy assessment population, participants who completed the survey and evaluable for efficacy; Participants who treated for reflux esophagitis within Efficacy assessment population and evaluable for subjective symptoms were analyzed for this outcome measure. | Percentage of Participants | NUMBER |
Source ClinicalTrials.gov
Results by group36
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Gastric Ulcer Who Had One or More Adverse Drug Reactions | Vonoprazan 20 mg | 1.00 | Percentage of Participants | ||
| Percentage of Participants With Duodenal Ulcer Who Had One or More Adverse Drug Reactions | Vonoprazan 20 mg | 1.21 | Percentage of Participants | ||
| Percentage of Participants With Reflux Esophagitis Who Had One or More Adverse Drug Reactions | Vonoprazan 20 mg | 0.78 | Percentage of Participants | ||
| Endoscopic Cure Rate in Participants With Gastric Ulcer | Vonoprazan 20 mg | 78.72 | 95% Confidence Interval 74.80 to 82.28 | Percentage of Participants | |
| Endoscopic Cure Rate in Participants With Duodenal Ulcer | Vonoprazan 20 mg | 88.46 | 95% Confidence Interval 83.66 to 92.26 | Percentage of Participants | |
| Endoscopic Cure Rate in Participants With Reflux Esophagitis | Vonoprazan 20 mg | 65.04 | 95% Confidence Interval 58.44 to 71.25 | Percentage of Participants | |
| Percentage of Participants With Gastric Ulcer Whose Subjective Symptoms Improved | Vonoprazan 20 mg | Heartburn | 96.68 | 95% Confidence Interval 93.28 to 98.66 | Percentage of Participants |
| Percentage of Participants With Gastric Ulcer Whose Subjective Symptoms Improved | Vonoprazan 20 mg | Acid Reflux | 96.86 | 95% Confidence Interval 92.81 to 98.97 | Percentage of Participants |
| Percentage of Participants With Gastric Ulcer Whose Subjective Symptoms Improved | Vonoprazan 20 mg | Postprandial Fullness | 96.09 | 95% Confidence Interval 93.27 to 97.96 | Percentage of Participants |
| Percentage of Participants With Gastric Ulcer Whose Subjective Symptoms Improved | Vonoprazan 20 mg | Early Satiation | 97.08 | 95% Confidence Interval 93.31 to 99.04 | Percentage of Participants |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Vonoprazan 20 mg | 3,183 | |
| Overall Study | COMPLETED | Vonoprazan 20 mg | 3,125 | |
| Overall Study | NOT COMPLETED | Vonoprazan 20 mg | 58 |
Source ClinicalTrials.gov
Adverse events18
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 | Nausea | Gastrointestinal disorders | Vonoprazan 20 mg | 3 | 3,125 | |
| other | Rash | Skin and subcutaneous tissue disorders | Vonoprazan 20 mg | 4 | 3,125 | |
| other | Urticaria | Skin and subcutaneous tissue disorders | Vonoprazan 20 mg | 3 | 3,125 | |
| serious | Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Vonoprazan 20 mg | 2 | 3,125 | |
| serious | Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Vonoprazan 20 mg | 4 | 3,125 | |
| serious | Lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Vonoprazan 20 mg | 1 | 3,125 | |
| serious | Oesophageal carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Vonoprazan 20 mg | 1 | 3,125 | |
| serious | Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Vonoprazan 20 mg | 1 | 3,125 | |
| serious | Rectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Vonoprazan 20 mg | 1 | 3,125 | |
| serious | Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Vonoprazan 20 mg | 2 | 3,125 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Vonoprazan 20 mg | 6 | 3,125 |
| Total, other adverse events | Vonoprazan 20 mg | 10 | 3,125 |
| Total, serious adverse events | Vonoprazan 20 mg | 20 | 3,125 |
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/NCT03214952
GET https://conductscience.org/api/trials/v1/NCT03214952/results?page=2