Trial · NCT02388737
Efficacy and Safety of Vonoprazan Compared to Lansoprazole in the Maintenance Treatment of Erosive Esophagitis
NCT02388737, Phase 3, Completed, Takeda; results first posted 2020-02-21
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety of Vonoprazan Compared to Lansoprazole in the Maintenance Treatment of Erosive Esophagitis. Trials, record NCT02388737. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02388737
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Vonoprazan Compared to Lansoprazole in the Maintenance Treatment of Erosive Esophagitis
- NCT number
- NCT02388737
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 703 participants, actual
- Lead sponsor
- Takeda
- Conditions
- Erosive Esophagitis
- Interventions
- Vonoprazan, Lansoprazole, Vonoprazan Placebo, Lansoprazole Placebo
- First posted
- 2015-03-17
- Last updated
- 2020-02-21
- Results first posted
- 2020-02-21
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 Recurrence of Erosive Esophagitis as Confirmed on Endoscopy After the 24-week Maintenance Phase | 24 weeks | Erosive esophagitis recurrence is defined as participants endoscopically confirmed to have erosive esophagitis (Los Angeles \[LA\] classification grades A to D) during the Maintenance Phase (24 weeks). Grade A: \>/=1 mucosal breaks \</=5 mm, none of which extends between the tops of the mucosal folds; Grade B: \>/=1 mucosal breaks \>5 mm, none of which extends between the tops of two mucosal folds; Grade C: mucosal breaks that extend between the tops of two or more mucosal folds, but which involve \<75% of esophageal circumference; Grade D: mucosal breaks which involve \>/=75% of esophageal circumference. |
| Secondary | Percentage of Participants With Recurrence of Erosive Esophagitis After 12 Weeks of Treatment in the Maintenance Phase | 12 weeks | Erosive esophagitis recurrence is defined as endoscopically confirmed to have erosive esophagitis (LA classification grades A to D) during the Maintenance Phase (12 weeks). Grade A: \>/=1 mucosal breaks \</=5 mm, none of which extends between the tops of the mucosal folds; Grade B: \>/=1 mucosal breaks \>5 mm, none of which extends between the tops of two mucosal folds; Grade C: mucosal breaks that extend between the tops of two or more mucosal folds, but which involve \<75% of esophageal circumference; Grade D: mucosal breaks which involve \>/=75% of esophageal circumference. |
| Secondary | Number of Participants With Adverse Events (AEs) | From Day 1 to 14 days after the last dose of study medication (up to 26 weeks) | An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug whether or not it is considered related to the drug. |
| Secondary | Number of Participants With Abnormal Clinical Laboratory Findings | From Day 1 to 14 days after the last dose of study medication (up to 26 weeks) | Clinical laboratory safety tests included chemistry, hematology and urinalysis. Number of participants with any markedly abnormal values in laboratory tests collected throughout study is reported. ALT = alanine aminotransferase, AST = aspartate aminotransferase, GGT = gamma-glutamyl transferase, CPK = creatine phosphokinase, BUN = blood urea nitrogen, LLN = lower limit of normal or lower reference limit, ULN = upper limit of normal or upper reference limit, g/L = grams per liter, U/L = units per liter, mmol/L = millimoles per liter, pmol/L = picomoles per liter. |
| Secondary | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | From Day 1 to 14 days after the last dose of study medication (up to 26 weeks) | Number of participants with any markedly abnormal 12-lead ECG findings is reported. bpm = beats per minute, msec = milliseconds, CHG= change from baseline. |
| Secondary | Number of Participants With Abnormal Vital Sign Measurements | From Day 1 to 14 days after the last dose of study medication (up to 26 weeks) | The percentage of participants with any markedly abnormal vital sign measurements including (body temperature, blood pressure and pulse), mmHg = millimeters of mercury. |
| Secondary | Change From Baseline in Serum Gastrin | Baseline and Weeks 4, 12 and 24 | |
| Secondary | Change From Baseline in Serum Pepsinogen I | Baseline and Weeks 4, 12 and 24 | |
| Secondary | Change From Baseline in Serum Pepsinogen II | Baseline and Weeks 4, 12 and 24 |
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 Recurrence of Erosive Esophagitis as Confirmed on Endoscopy After the 24-week Maintenance Phase | 24 weeks | Full analysis set included all randomized participants who received at least 1 dose of the Maintenance Phase drug and had at least 1 post-baseline endoscopy, and was based on randomized treatment. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Recurrence of Erosive Esophagitis After 12 Weeks of Treatment in the Maintenance Phase | 12 weeks | Full analysis set included all randomized participants who received at least 1 dose of the Maintenance Phase drug and had at least 1 post-baseline endoscopy, and was based on randomized treatment. | percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Adverse Events (AEs) | From Day 1 to 14 days after the last dose of study medication (up to 26 weeks) | Safety analysis set included all participants who took at least 1 dose of the Maintenance Phase drug and was based on the treatment received in the Maintenance Phase. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Abnormal Clinical Laboratory Findings | From Day 1 to 14 days after the last dose of study medication (up to 26 weeks) | Safety analysis set included all participants who took at least 1 dose of the Maintenance Phase drug and was based on the treatment received in the Maintenance Phase. The number analyzed is the number of participants with data available for analysis. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | From Day 1 to 14 days after the last dose of study medication (up to 26 weeks) | Safety analysis set included all participants who took at least 1 dose of the Maintenance Phase drug and was based on the treatment received in the Maintenance Phase. The number analyzed is the number of participants with data available for analysis. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Abnormal Vital Sign Measurements | From Day 1 to 14 days after the last dose of study medication (up to 26 weeks) | Safety analysis set included all participants who took at least 1 dose of the Maintenance Phase drug and was based on the treatment received in the Maintenance Phase. The number analyzed is the number of participants with data available for analysis. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in Serum Gastrin | Baseline and Weeks 4, 12 and 24 | Safety analysis set included all participants who took at least 1 dose of the Maintenance Phase drug and was based on the treatment received in the Maintenance Phase. The number analyzed is the number of participants with data available for analysis. | pmol/L | MEAN |
| SECONDARY | Change From Baseline in Serum Pepsinogen I | Baseline and Weeks 4, 12 and 24 | Safety analysis set included all participants who took at least 1 dose of the Maintenance Phase drug and was based on the treatment received in the Maintenance Phase. The number analyzed is the number of participants with data available for analysis. | ug/L | MEAN |
| SECONDARY | Change From Baseline in Serum Pepsinogen II | Baseline and Weeks 4, 12 and 24 | Safety analysis set included all participants who took at least 1 dose of the Maintenance Phase drug and was based on the treatment received in the Maintenance Phase.The number analyzed is the number of participants with data available for analysis. | ug/L | MEAN |
Source ClinicalTrials.gov
Results by group147
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 Recurrence of Erosive Esophagitis as Confirmed on Endoscopy After the 24-week Maintenance Phase | Vonoprazan 10 mg | 13.3 | 95% Confidence Interval 8.684 to 19.084 | percentage of participants | |
| Percentage of Participants With Recurrence of Erosive Esophagitis as Confirmed on Endoscopy After the 24-week Maintenance Phase | Vonoprazan 20 mg | 12.3 | 95% Confidence Interval 7.765 to 18.158 | percentage of participants | |
| Percentage of Participants With Recurrence of Erosive Esophagitis as Confirmed on Endoscopy After the 24-week Maintenance Phase | Lansoprazole 15 mg | 25.5 | 95% Confidence Interval 19.412 to 32.481 | percentage of participants | |
| Percentage of Participants With Recurrence of Erosive Esophagitis After 12 Weeks of Treatment in the Maintenance Phase | Vonoprazan 10 mg | 27.8 | 95% Confidence Interval 9.695 to 53.480 | percentage of participants | |
| Percentage of Participants With Recurrence of Erosive Esophagitis After 12 Weeks of Treatment in the Maintenance Phase | Vonoprazan 20 mg | 10.0 | 95% Confidence Interval 1.235 to 31.698 | percentage of participants | |
| Percentage of Participants With Recurrence of Erosive Esophagitis After 12 Weeks of Treatment in the Maintenance Phase | Lansoprazole 15 mg | 35.0 | 95% Confidence Interval 15.391 to 59.219 | percentage of participants | |
| Number of Participants With Adverse Events (AEs) | Vonoprazan 10 mg | 157 | Participants | ||
| Number of Participants With Adverse Events (AEs) | Vonoprazan 20 mg | 156 | Participants | ||
| Number of Participants With Adverse Events (AEs) | Lansoprazole 15 mg | 158 | Participants | ||
| Number of Participants With Abnormal Clinical Laboratory Findings | Vonoprazan 10 mg | Hematology: Red Blood Cells (>1.2xULN) | 1 | Participants |
1 to 10 of 147Source ClinicalTrials.gov
See all 147 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Vonoprazan 10 mg | 235 | |
| Overall Study | STARTED | Vonoprazan 20 mg | 226 | |
| Overall Study | STARTED | Lansoprazole 15 mg | 242 | |
| Overall Study | COMPLETED | Vonoprazan 10 mg | 181 | |
| Overall Study | COMPLETED | Vonoprazan 20 mg | 166 | |
| Overall Study | COMPLETED | Lansoprazole 15 mg | 180 | |
| Overall Study | NOT COMPLETED | Vonoprazan 10 mg | 54 | |
| Overall Study | NOT COMPLETED | Vonoprazan 20 mg | 60 | |
| Overall Study | NOT COMPLETED | Lansoprazole 15 mg | 62 |
Source ClinicalTrials.gov
Adverse events126
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 | 15 | 235 | |
| other | Diarrhoea | Gastrointestinal disorders | Vonoprazan 20 mg | 21 | 226 | |
| other | Diarrhoea | Gastrointestinal disorders | Lansoprazole 15 mg | 17 | 242 | |
| other | Dyspepsia | Gastrointestinal disorders | Vonoprazan 10 mg | 18 | 235 | |
| other | Dyspepsia | Gastrointestinal disorders | Vonoprazan 20 mg | 10 | 226 | |
| other | Dyspepsia | Gastrointestinal disorders | Lansoprazole 15 mg | 12 | 242 | |
| other | Gastric polyps | Gastrointestinal disorders | Vonoprazan 10 mg | 11 | 235 | |
| other | Gastric polyps | Gastrointestinal disorders | Vonoprazan 20 mg | 12 | 226 | |
| other | Gastric polyps | Gastrointestinal disorders | Lansoprazole 15 mg | 8 | 242 | |
| other | Abdominal distension | Gastrointestinal disorders | Vonoprazan 10 mg | 5 | 235 |
1 to 10 of 126Source ClinicalTrials.gov
See all 126 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Vonoprazan 10 mg | 0 | 235 |
| Total, all-cause mortality | Vonoprazan 20 mg | 0 | 226 |
| Total, all-cause mortality | Lansoprazole 15 mg | 1 | 242 |
| Total, other adverse events | Vonoprazan 10 mg | 81 | 235 |
| Total, other adverse events | Vonoprazan 20 mg | 79 | 226 |
| Total, other adverse events | Lansoprazole 15 mg | 79 | 242 |
| Total, serious adverse events | Vonoprazan 10 mg | 10 | 235 |
| Total, serious adverse events | Vonoprazan 20 mg | 8 | 226 |
| Total, serious adverse events | Lansoprazole 15 mg | 12 | 242 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 38654422 | 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/NCT02388737
GET https://conductscience.org/api/trials/v1/NCT02388737/results?page=2