Trial · NCT02388724
Efficacy and Safety of Oral Once-Daily Vonoprazan (TAK-438) in Participants With Erosive Esophagitis
NCT02388724, Phase 3, Completed, Takeda; results first posted 2019-06-03
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety of Oral Once-Daily Vonoprazan (TAK-438) in Participants With Erosive Esophagitis. Trials, record NCT02388724. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02388724
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Oral Once-Daily Vonoprazan (TAK-438) in Participants With Erosive Esophagitis
- NCT number
- NCT02388724
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 481 participants, actual
- Lead sponsor
- Takeda
- Conditions
- Erosive Esophagitis
- Interventions
- Vonoprazan, Lansoprazole, Vonoprazan Placebo, Lansoprazole Placebo
- First posted
- 2015-03-17
- Last updated
- 2019-06-03
- Results first posted
- 2019-06-03
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 Endoscopic Healing of Erosive Esophagitis During the 8-Week Treatment Phase | 8 weeks | Endoscopic healing is defined as participants endoscopically diagnosed as Los Angeles classification grade O during the treatment phase. Grade O indicates there are no mucosal breaks in the mucosa. |
| Secondary | Percentage of Participants With Endoscopic Healing of Erosive Esophagitis After 2 Weeks and 4 Weeks of Treatment | Week 2 and Week 4 | Endoscopic healing is defined as participants endoscopically diagnosed as Los Angeles classification grade O during the treatment phase. Grade O indicates there are no mucosal breaks in the mucosa. |
| Secondary | Number of Participants Reporting Who Had One or More Treatment-emergent Adverse Event (TEAE) | On or after the start of study drug (Day 1) to 14 days after the last dose of study medication (up to 10 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 Markedly Abnormal Clinical Laboratory Findings | From Day 1 to 14 days after the last dose of study medication (up to 10 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 Markedly Abnormal Electrocardiogram (ECG) Findings | From Day 1 to 14 days after the last dose of study medication (up to 10 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 Markedly Abnormal Vital Sign Measurements | From Day 1 to 14 days after the last dose of study medication (up to 10 weeks) | Number of participants with any markedly abnormal vital signs measurements is reported. Vital signs included body temperature (oral, tympanic, or infra-axillary measurement), sitting blood pressure (5 minutes), and pulse. °C = degrees Celsius, mmHg = millimeters of mercury, bpm = beats per minute. |
| Secondary | Change From Baseline in Serum Gastrin | Baseline and Weeks 2, 4, and 8 | The change between the serum gastrin values collected at Weeks 2, 4, and 8 relative to baseline. |
| Secondary | Change From Baseline in Serum Pepsinogen I | Baseline and Weeks 2, 4, and 8 | The change between the serum pepsinogen I values collected at Weeks 2, 4, and 8 relative to baseline. |
| Secondary | Change From Baseline in Serum Pepsinogen II | Baseline and Weeks 2, 4, and 8 | The change between the serum pepsinogen II values collected at Weeks 2, 4, and 8 relative to baseline. |
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 Endoscopic Healing of Erosive Esophagitis During the 8-Week Treatment Phase | 8 weeks | The full analysis set (FAS) included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline endoscopy. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Endoscopic Healing of Erosive Esophagitis After 2 Weeks and 4 Weeks of Treatment | Week 2 and Week 4 | The full analysis set (FAS) included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline endoscopy. Number analyzed is the number of participants with data available at the given time-point. | percentage of participants | NUMBER |
| SECONDARY | Number of Participants Reporting Who Had One or More Treatment-emergent Adverse Event (TEAE) | On or after the start of study drug (Day 1) to 14 days after the last dose of study medication (up to 10 weeks) | The safety analysis set (SAF) included all participants who took at least 1 dose of study medication. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Markedly Abnormal Clinical Laboratory Findings | From Day 1 to 14 days after the last dose of study medication (up to 10 weeks) | The safety analysis set (SAF) included all participants who took at least 1 dose of study medication. The number analyzed is the number of participants with data available for analysis. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Markedly Abnormal Electrocardiogram (ECG) Findings | From Day 1 to 14 days after the last dose of study medication (up to 10 weeks) | The safety analysis set (SAF) included all participants who took at least 1 dose of study medication. The number analyzed is the number of participants with data available for analysis. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Markedly Abnormal Vital Sign Measurements | From Day 1 to 14 days after the last dose of study medication (up to 10 weeks) | The safety analysis set (SAF) included all participants who took at least 1 dose of study medication. 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 2, 4, and 8 | The safety analysis set (SAF) included all participants who took at least 1 dose of study medication. 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 2, 4, and 8 | The safety analysis set (SAF) included all participants who took at least 1 dose of study medication. The number analyzed is the number of participants with data available for analysis. | micrograms per liter (ug/L) | MEAN |
| SECONDARY | Change From Baseline in Serum Pepsinogen II | Baseline and Weeks 2, 4, and 8 | The safety analysis set (SAF) included all participants who took at least 1 dose of study medication. The number analyzed is the number of participants with data available for analysis. | ug/L | MEAN |
Source ClinicalTrials.gov
Results by group74
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 Endoscopic Healing of Erosive Esophagitis During the 8-Week Treatment Phase | Vonoprazan 20 mg | 92.4 | 95% Confidence Interval 88.310 to 95.456 | percentage of participants | |
| Percentage of Participants With Endoscopic Healing of Erosive Esophagitis During the 8-Week Treatment Phase | Lansoprazole 30 mg | 91.3 | 95% Confidence Interval 86.890 to 94.607 | percentage of participants | |
| Percentage of Participants With Endoscopic Healing of Erosive Esophagitis After 2 Weeks and 4 Weeks of Treatment | Vonoprazan 20 mg | 2 Weeks | 75.0 | 95% Confidence Interval 68.970 to 80.391 | percentage of participants |
| Percentage of Participants With Endoscopic Healing of Erosive Esophagitis After 2 Weeks and 4 Weeks of Treatment | Lansoprazole 30 mg | 2 Weeks | 67.8 | 95% Confidence Interval 61.341 to 73.869 | percentage of participants |
| Percentage of Participants With Endoscopic Healing of Erosive Esophagitis After 2 Weeks and 4 Weeks of Treatment | Vonoprazan 20 mg | 4 Weeks | 85.3 | 95% Confidence Interval 80.146 to 89.538 | percentage of participants |
| Percentage of Participants With Endoscopic Healing of Erosive Esophagitis After 2 Weeks and 4 Weeks of Treatment | Lansoprazole 30 mg | 4 Weeks | 83.5 | 95% Confidence Interval 78.035 to 88.035 | percentage of participants |
| Number of Participants Reporting Who Had One or More Treatment-emergent Adverse Event (TEAE) | Vonoprazan 20 mg | 93 | Participants | ||
| Number of Participants Reporting Who Had One or More Treatment-emergent Adverse Event (TEAE) | Lansoprazole 30 mg | 86 | Participants | ||
| Number of Participants With Markedly Abnormal Clinical Laboratory Findings | Vonoprazan 20 mg | Hemoglobin (<0.8 x LLN g/L) | 0 | Participants | |
| Number of Participants With Markedly Abnormal Clinical Laboratory Findings | Lansoprazole 30 mg | Hemoglobin (<0.8 x LLN g/L) | 1 | Participants |
1 to 10 of 74Source ClinicalTrials.gov
See all 74 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Vonoprazan 20 mg | 244 | |
| Overall Study | STARTED | Lansoprazole 30 mg | 237 | |
| Overall Study | Safety Set: Randomized But Not Treated | Vonoprazan 20 mg | 0 | |
| Overall Study | Safety Set: Randomized But Not Treated | Lansoprazole 30 mg | 2 | |
| Overall Study | COMPLETED | Vonoprazan 20 mg | 232 | |
| Overall Study | COMPLETED | Lansoprazole 30 mg | 224 | |
| Overall Study | NOT COMPLETED | Vonoprazan 20 mg | 12 | |
| Overall Study | NOT COMPLETED | Lansoprazole 30 mg | 13 |
Source ClinicalTrials.gov
Adverse events14
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 | Blood gastrin increased | Investigations | Vonoprazan 20 mg | 13 | 244 | |
| other | Blood gastrin increased | Investigations | Lansoprazole 30 mg | 4 | 235 | |
| serious | Glaucoma | Eye disorders | Vonoprazan 20 mg | 0 | 244 | |
| serious | Glaucoma | Eye disorders | Lansoprazole 30 mg | 1 | 235 | |
| serious | Large intestine polyp | Gastrointestinal disorders | Vonoprazan 20 mg | 0 | 244 | |
| serious | Large intestine polyp | Gastrointestinal disorders | Lansoprazole 30 mg | 1 | 235 | |
| serious | Bile duct stone | Hepatobiliary disorders | Vonoprazan 20 mg | 1 | 244 | |
| serious | Bile duct stone | Hepatobiliary disorders | Lansoprazole 30 mg | 0 | 235 | |
| serious | Gastroenteritis | Infections and infestations | Vonoprazan 20 mg | 0 | 244 | |
| serious | Gastroenteritis | Infections and infestations | Lansoprazole 30 mg | 1 | 235 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Vonoprazan 20 mg | 0 | 244 |
| Total, all-cause mortality | Lansoprazole 30 mg | 0 | 235 |
| Total, other adverse events | Vonoprazan 20 mg | 13 | 244 |
| Total, other adverse events | Lansoprazole 30 mg | 4 | 235 |
| Total, serious adverse events | Vonoprazan 20 mg | 3 | 244 |
| Total, serious adverse events | Lansoprazole 30 mg | 3 | 235 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 31409606 | 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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Vonoprazan 20 mg vs Lansoprazole 30 mg: Number of Participants Reporting Who Had One or More Treatment-emergent Adverse Event (TEAE) | Trial comparisons |
| Vonoprazan 20 mg vs Lansoprazole 30 mg: deaths from any cause | Trial comparisons |
| Vonoprazan 20 mg vs Lansoprazole 30 mg: serious adverse events | Trial comparisons |
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/NCT02388724
GET https://conductscience.org/api/trials/v1/NCT02388724/results?page=2