Trial · NCT03214081
Special Drug Use Surveillance of Vonoprazan for "Maintenance Therapy of Reflux Esophagitis: Long-term Use"
NCT03214081, Completed, Takeda; results first posted 2019-10-23
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Special Drug Use Surveillance of Vonoprazan for "Maintenance Therapy of Reflux Esophagitis: Long-term Use". Trials, record NCT03214081. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03214081
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 "Maintenance Therapy of Reflux Esophagitis: Long-term Use"
- NCT number
- NCT03214081
- Status
- Completed
- Enrollment
- 1,237 participants, actual
- Lead sponsor
- Takeda
- Conditions
- Reflux Esophagitis
- Interventions
- Vonoprazan
- First posted
- 2017-07-11
- Last updated
- 2025-06-10
- Results first posted
- 2019-10-23
Source ClinicalTrials.gov
Registered outcomes12
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 | Endoscopic Relapse Rate | From the initiation of the maintenance therapy to Month 12 (or discontinuation of the therapy), up to 12 months | Endoscopic relapse rate was defined as a percentage of participants who met the criteria of Grade A to D in the modified Los Angeles (LA) classification. The modified LA classification graded endoscopic findings as follows- Grade N: normal mucosa; Grade M: minimal changes to the mucosa, such as erythema and/or whitish turbidity; Grade A: non-confluent mucosal breaks \<5 mm in length; Grade B: nonconfluent mucosal breaks ≥ 5 mm in length; Grade C: confluent mucosal breaks \<75% circumferential; Grade D: confluent mucosal breaks \>=75% circumferential. |
| Secondary | Number of Participants With Recorded Severity of Subjective Symptoms of Heartburn | Baseline, Month 6 and at Month 12 | Presence or absence and severity of subjective symptoms were collected from participants during medical interviews of each visit as none (asymptomatic), mild (occasionally or slightly symptomatic), moderate (considerably symptomatic), severe (unendurably symptomatic), and unknown. Number of participants who had mild, moderate, or severe heartburn at each time points were reported. |
| Secondary | Number of Participants With Recorded Severity of Subjective Symptoms of Acid Reflux | Baseline, Month 6 and at Month 12 | Presence or absence and severity of subjective symptoms were collected from participants during medical interviews of each visit as none (asymptomatic), mild (occasionally or slightly symptomatic), moderate (considerably symptomatic), severe (unendurably symptomatic), and unknown. Number of participants who had mild, moderate, or severe acid reflux at each time points were reported. |
| Secondary | Number of Participants With Recorded Severity of Subjective Symptoms of Postprandial Fullness | Baseline, Month 6 and at Month 12 | Presence or absence and severity of subjective symptoms were collected from participants during medical interviews of each visit as none (asymptomatic), mild (occasionally or slightly symptomatic), moderate (considerably symptomatic), severe (unendurably symptomatic), and unknown. Number of participants who had mild, moderate, or severe postprandial fullness at each time points were reported. |
| Secondary | Number of Participants With Recorded Severity of Subjective Symptoms of Early Satiation | Baseline, Month 6 and at Month 12 | Presence or absence and severity of subjective symptoms were collected from participants during medical interviews of each visit as none (asymptomatic), mild (occasionally or slightly symptomatic), moderate (considerably symptomatic), severe (unendurably symptomatic), and unknown. Number of participants who had mild, moderate, or severe early satiation at each time points were reported. |
| Secondary | Number of Participants With Recorded Severity of Subjective Symptoms of Epigastric Pain | Baseline, Month 6 and at Month 12 | Presence or absence and severity of subjective symptoms were collected from participants during medical interviews of each visit as none (asymptomatic), mild (occasionally or slightly symptomatic), moderate (considerably symptomatic), severe (unendurably symptomatic), and unknown. Number of participants who had mild, moderate, or severe epigastric pain at each time points were reported. |
| Secondary | Number of Participants With Recorded Severity of Subjective Symptoms of Epigastric Burning | Baseline, Month 6 and at Month 12 | Presence or absence and severity of subjective symptoms were collected from participants during medical interviews of each visit as none (asymptomatic), mild (occasionally or slightly symptomatic), moderate (considerably symptomatic), severe (unendurably symptomatic), and unknown. Number of participants who had mild, moderate, or severe epigastric burning at each time points were reported. |
| Secondary | Number of Participants With Recorded Severity of Subjective Symptoms of Abdominal Bloating | Baseline, Month 6 and at Month 12 | Presence or absence and severity of subjective symptoms were collected from participants during medical interviews of each visit as none (asymptomatic), mild (occasionally or slightly symptomatic), moderate (considerably symptomatic), severe (unendurably symptomatic), and unknown. Number of participants who had mild, moderate, or severe abdominal bloating at each time points were reported. |
| Secondary | Number of Participants With Recorded Severity of Subjective Symptoms of Nausea/Vomiting | Baseline, Month 6 and at Month 12 | Presence or absence and severity of subjective symptoms were collected from participants during medical interviews of each visit as none (asymptomatic), mild (occasionally or slightly symptomatic), moderate (considerably symptomatic), severe (unendurably symptomatic), and unknown. Number of participants who had mild, moderate, or severe nausea/vomiting at each time points were reported. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
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 | Endoscopic Relapse Rate | From the initiation of the maintenance therapy to Month 12 (or discontinuation of the therapy), 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 | Number of Participants With Recorded Severity of Subjective Symptoms of Heartburn | Baseline, Month 6 and at Month 12 | 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. Number analyzed is the number of participants who were evaluable at each time point. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Recorded Severity of Subjective Symptoms of Acid Reflux | Baseline, Month 6 and at Month 12 | 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. Number analyzed is the number of participants who were evaluable at each time point. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Recorded Severity of Subjective Symptoms of Postprandial Fullness | Baseline, Month 6 and at Month 12 | 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. Number analyzed is the number of participants who were evaluable at each time point. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Recorded Severity of Subjective Symptoms of Early Satiation | Baseline, Month 6 and at Month 12 | 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. Number analyzed is the number of participants who were evaluable at each time point. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Recorded Severity of Subjective Symptoms of Epigastric Pain | Baseline, Month 6 and at Month 12 | 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. Number analyzed is the number of participants who were evaluable at each time point. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Recorded Severity of Subjective Symptoms of Epigastric Burning | Baseline, Month 6 and at Month 12 | 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. Number analyzed is the number of participants who were evaluable at each time point. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Recorded Severity of Subjective Symptoms of Abdominal Bloating | Baseline, Month 6 and at Month 12 | 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. Number analyzed is the number of participants who were evaluable at each time point. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Recorded Severity of Subjective Symptoms of Nausea/Vomiting | Baseline, Month 6 and at Month 12 | 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. Number analyzed is the number of participants who were evaluable at each time point. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group92
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 or 20 mg | 2.30 | Percentage of Participants | ||
| Endoscopic Relapse Rate | Vonoprazan 10 mg or 20 mg | 4.00 | 95% Confidence Interval 2.35 to 6.33 | Percentage of Participants | |
| Number of Participants With Recorded Severity of Subjective Symptoms of Heartburn | Vonoprazan 10 mg or 20 mg | Baseline / Mild | 368 | Participants | |
| Number of Participants With Recorded Severity of Subjective Symptoms of Heartburn | Vonoprazan 10 mg or 20 mg | Baseline / Moderate | 270 | Participants | |
| Number of Participants With Recorded Severity of Subjective Symptoms of Heartburn | Vonoprazan 10 mg or 20 mg | Baseline / Severe | 26 | Participants | |
| Number of Participants With Recorded Severity of Subjective Symptoms of Heartburn | Vonoprazan 10 mg or 20 mg | Month 6 / Mild | 136 | Participants | |
| Number of Participants With Recorded Severity of Subjective Symptoms of Heartburn | Vonoprazan 10 mg or 20 mg | Month 6 / Moderate | 17 | Participants | |
| Number of Participants With Recorded Severity of Subjective Symptoms of Heartburn | Vonoprazan 10 mg or 20 mg | Month 6 / Severe | 2 | Participants | |
| Number of Participants With Recorded Severity of Subjective Symptoms of Heartburn | Vonoprazan 10 mg or 20 mg | Month 12 / Mild | 84 | Participants | |
| Number of Participants With Recorded Severity of Subjective Symptoms of Heartburn | Vonoprazan 10 mg or 20 mg | Month 12 / Moderate | 7 | Participants |
1 to 10 of 92Source ClinicalTrials.gov
See all 92 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 10 mg or 20 mg | 1,237 | |
| Overall Study | COMPLETED | Vonoprazan 10 mg or 20 mg | 1,174 | |
| Overall Study | NOT COMPLETED | Vonoprazan 10 mg or 20 mg | 63 |
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 | Diarrhoea | Gastrointestinal disorders | Vonoprazan 10 mg or 20 mg | 11 | 1,174 | |
| serious | Pneumonia | Infections and infestations | Vonoprazan 10 mg or 20 mg | 2 | 1,174 | |
| serious | Peritonitis bacterial | Infections and infestations | Vonoprazan 10 mg or 20 mg | 1 | 1,174 | |
| serious | Acute Leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Vonoprazan 10 mg or 20 mg | 1 | 1,174 | |
| serious | Lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Vonoprazan 10 mg or 20 mg | 1 | 1,174 | |
| serious | Myelodysplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Vonoprazan 10 mg or 20 mg | 1 | 1,174 | |
| serious | Hepatic cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Vonoprazan 10 mg or 20 mg | 1 | 1,174 | |
| serious | Myelopathy | Nervous system disorders | Vonoprazan 10 mg or 20 mg | 1 | 1,174 | |
| serious | Subarachnoid haemorrhage | Nervous system disorders | Vonoprazan 10 mg or 20 mg | 1 | 1,174 | |
| serious | Angina unstable | Cardiac disorders | Vonoprazan 10 mg or 20 mg | 1 | 1,174 |
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 10 mg or 20 mg | 7 | 1,174 |
| Total, other adverse events | Vonoprazan 10 mg or 20 mg | 11 | 1,174 |
| Total, serious adverse events | Vonoprazan 10 mg or 20 mg | 15 | 1,174 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 41982134 | 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 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/NCT03214081
GET https://conductscience.org/api/trials/v1/NCT03214081/results?page=2