Trial · NCT03050307
Comparison of TAK-438 (Vonoprazan) to Lansoprazole in the Treatment of Gastric Ulcer Participants With or Without Helicobacter Pylori Infection
NCT03050307, Phase 3, Completed, Takeda; results first posted 2021-06-18
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Comparison of TAK-438 (Vonoprazan) to Lansoprazole in the Treatment of Gastric Ulcer Participants With or Without Helicobacter Pylori Infection. Trials, record NCT03050307. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03050307
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Comparison of TAK-438 (Vonoprazan) to Lansoprazole in the Treatment of Gastric Ulcer Participants With or Without Helicobacter Pylori Infection
- NCT number
- NCT03050307
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 234 participants, actual
- Lead sponsor
- Takeda
- Conditions
- Gastric Ulcer
- Interventions
- TAK-438, Lansoprazole, TAK-438 Placebo, Lansoprazole Placebo, Bismuth-Containing Quadruple Therapy
- First posted
- 2017-02-10
- Last updated
- 2021-06-18
- Results first posted
- 2021-06-18
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Endoscopically Confirmed Healing of Gastric Ulcers (GUs) at Weeks 4 or 8 | Week 4 or 8 | Endoscopic healing was defined as the disappearance of all white coats associated with GUs confirmed endoscopically. |
| Secondary | Percentage of Helicobacter Pylori Infected (HP+) Participants With Successful HP Eradication After 4 or 8 Weeks of Treatment | 4 weeks post treatment (up to approximately 12 weeks) | HP infection status was determined by 13C-UBT. The urea breath test is used to detect infection with HP, a bacteria associated with stomach ulcers, by testing individual breath samples in a central laboratory. The data is provided only for HP+ participants. The participant could take 4 or 8 weeks of treatment for GU healing, then additional 4 weeks later, to have the urea breath test (UBT) test to detect HP. |
| Secondary | Percentage of Participants With Endoscopically Confirmed Healing of GU at Week 4 | Week 4 | Endoscopic healing was defined as the disappearance of all white coats associated with GUs confirmed endoscopically. |
| Secondary | Percentage of Participants With Post-treatment Resolution of Gastrointestinal Symptoms Associated With GU | Week 2 up to Week 8 | The gastrointestinal symptoms included epigastric pain \[postprandial, fasting, nocturnal\], abdominal bloating, nausea/vomiting, heartburn, lack of appetite. The severity of gastrointestinal symptoms associated with GU were recorded as: none = 0, mild = 1, moderate = 2 or severe = 3. The data is reported in categories for percentage of participants with resolution of gastrointestinal symptoms associated with GU. |
Source ClinicalTrials.gov
Outcomes4
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 Endoscopically Confirmed Healing of Gastric Ulcers (GUs) at Weeks 4 or 8 | Week 4 or 8 | Full Analysis Set (FAS) population included all randomized participants who received at least 1 dose of the study drug. Overall number of participants analyzed were participants with data available for analyses. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Helicobacter Pylori Infected (HP+) Participants With Successful HP Eradication After 4 or 8 Weeks of Treatment | 4 weeks post treatment (up to approximately 12 weeks) | FAS population included all randomized participants who received at least 1 dose of the study drug. Overall number of participants analyzed were participants with data available for analyses. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Endoscopically Confirmed Healing of GU at Week 4 | Week 4 | FAS population included all randomized participants who received at least 1 dose of the study drug. Overall number of participants analyzed were participants with data available for analyses. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Post-treatment Resolution of Gastrointestinal Symptoms Associated With GU | Week 2 up to Week 8 | FAS population included all randomized participants who received at least 1 dose of the study drug. Number analyzed is the number of participants with data available for analysis for the specific category. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group18
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 Endoscopically Confirmed Healing of Gastric Ulcers (GUs) at Weeks 4 or 8 | TAK-438 20 mg | 91.1 | 95% Confidence Interval 84.193 to 95.635 | percentage of participants | |
| Percentage of Participants With Endoscopically Confirmed Healing of Gastric Ulcers (GUs) at Weeks 4 or 8 | Lansoprazole 30 mg | 94.7 | 95% Confidence Interval 88.896 to 98.044 | percentage of participants | |
| Percentage of Helicobacter Pylori Infected (HP+) Participants With Successful HP Eradication After 4 or 8 Weeks of Treatment | TAK-438 20 mg | 88.0 | 95% Confidence Interval 78.439 to 94.363 | percentage of participants | |
| Percentage of Helicobacter Pylori Infected (HP+) Participants With Successful HP Eradication After 4 or 8 Weeks of Treatment | Lansoprazole 30 mg | 80.8 | 95% Confidence Interval 69.921 to 89.099 | percentage of participants | |
| Percentage of Participants With Endoscopically Confirmed Healing of GU at Week 4 | TAK-438 20 mg | 76.1 | 95% Confidence Interval 67.035 to 83.788 | percentage of participants | |
| Percentage of Participants With Endoscopically Confirmed Healing of GU at Week 4 | Lansoprazole 30 mg | 82.1 | 95% Confidence Interval 73.777 to 88.738 | percentage of participants | |
| Percentage of Participants With Post-treatment Resolution of Gastrointestinal Symptoms Associated With GU | TAK-438 20 mg | Epigastric Pain (Postprandial) | 78.9 | 95% Confidence Interval 54.435 to 93.948 | percentage of participants |
| Percentage of Participants With Post-treatment Resolution of Gastrointestinal Symptoms Associated With GU | Lansoprazole 30 mg | Epigastric Pain (Postprandial) | 80.0 | 95% Confidence Interval 59.296 to 93.169 | percentage of participants |
| Percentage of Participants With Post-treatment Resolution of Gastrointestinal Symptoms Associated With GU | TAK-438 20 mg | Epigastric Pain (Fasting/Nocturnal) | 85.0 | 95% Confidence Interval 70.165 to 94.290 | percentage of participants |
| Percentage of Participants With Post-treatment Resolution of Gastrointestinal Symptoms Associated With GU | Lansoprazole 30 mg | Epigastric Pain (Fasting/Nocturnal) | 80.5 | 95% Confidence Interval 65.133 to 91.179 | percentage of participants |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | TAK-438 20 mg | 115 | |
| Overall Study | STARTED | Lansoprazole 30 mg | 119 | |
| Overall Study | COMPLETED | TAK-438 20 mg | 107 | |
| Overall Study | COMPLETED | Lansoprazole 30 mg | 110 | |
| Overall Study | NOT COMPLETED | TAK-438 20 mg | 8 | |
| Overall Study | NOT COMPLETED | Lansoprazole 30 mg | 9 |
Source ClinicalTrials.gov
Adverse events20
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 | Pepsinogen test positive | Investigations | TAK-438 20 mg | 29 | 115 | |
| other | Pepsinogen test positive | Investigations | Lansoprazole 30 mg | 6 | 119 | |
| other | Pepsinogen I increased | Investigations | TAK-438 20 mg | 23 | 115 | |
| other | Pepsinogen I increased | Investigations | Lansoprazole 30 mg | 8 | 119 | |
| other | Blood gastrin increased | Investigations | TAK-438 20 mg | 24 | 115 | |
| other | Blood gastrin increased | Investigations | Lansoprazole 30 mg | 5 | 119 | |
| other | Alanine aminotransferase increased | Investigations | TAK-438 20 mg | 6 | 115 | |
| other | Alanine aminotransferase increased | Investigations | Lansoprazole 30 mg | 3 | 119 | |
| other | Dysgeusia | Nervous system disorders | TAK-438 20 mg | 2 | 115 | |
| other | Dysgeusia | Nervous system disorders | Lansoprazole 30 mg | 7 | 119 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | TAK-438 20 mg | 0 | 115 |
| Total, all-cause mortality | Lansoprazole 30 mg | 0 | 119 |
| Total, other adverse events | TAK-438 20 mg | 43 | 115 |
| Total, other adverse events | Lansoprazole 30 mg | 15 | 119 |
| Total, serious adverse events | TAK-438 20 mg | 3 | 115 |
| Total, serious adverse events | Lansoprazole 30 mg | 2 | 119 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 39085080 | 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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| TAK-438 20 mg vs Lansoprazole 30 mg: deaths from any cause | Trial comparisons |
| TAK-438 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/NCT03050307
GET https://conductscience.org/api/trials/v1/NCT03050307/registered