Trial · NCT03050359
Comparison of TAK-438 (Vonoprazan) to Lansoprazole in the Treatment of Duodenal Ulcer Participants With or Without Helicobacter Pylori Infection
NCT03050359, Phase 3, Completed, Takeda; results first posted 2020-06-12
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Comparison of TAK-438 (Vonoprazan) to Lansoprazole in the Treatment of Duodenal Ulcer Participants With or Without Helicobacter Pylori Infection. Trials, record NCT03050359. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03050359
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 Duodenal Ulcer Participants With or Without Helicobacter Pylori Infection
- NCT number
- NCT03050359
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 533 participants, actual
- Lead sponsor
- Takeda
- Conditions
- Duodenal Ulcer
- Interventions
- TAK-438, Lansoprazole, TAK-438 Placebo, Lansoprazole Placebo, Bismuth-Containing Quadruple Therapy
- First posted
- 2017-02-10
- Last updated
- 2020-06-12
- Results first posted
- 2020-06-12
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 Duodenal Ulcers | Week 4 or Week 6 | Endoscopic healing was defined as the disappearance of all white coats associated with duodenal ulcers as confirmed endoscopically. |
| Secondary | Percentage of Helicobacter Pylori Infected (HP+) Participants With Successful HP Eradication After 4 or 6 Weeks of Treatment | 4 weeks post treatment (Up to 10 weeks) | HP infection status was determined by \^13C Urea Breath Test (\^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. |
| Secondary | Percentage of Participants With Endoscopically Confirmed Healing of Duodenal Ulcer at Week 4 | Week 4 | Endoscopic healing is defined as the disappearance of all white coats associated with duodenal ulcers as confirmed endoscopically. |
| Secondary | Percentage of Participants With Posttreatment Resolution of Gastrointestinal Symptoms Associated With Duodenal Ulcer at Weeks 2 Through 6 | Week 2 up to Week 6 | The percentage of participants with resolution of various gastrointestinal symptoms are reported as categories. Gastrointestinal symptoms included epigastric pain (postprandial, fasting, nocturnal), abdominal bloating, nausea/vomiting, heartburn and lack of appetite. The severity of subjective symptoms of erosive esophagitis were recorded as: none = 0, mild = 1, moderate = 2 or severe = 3. |
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 Duodenal Ulcers | Week 4 or Week 6 | Full Analysis Set (FAS) included all participants who were randomized and 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 6 Weeks of Treatment | 4 weeks post treatment (Up to 10 weeks) | Participants from FAS, included all participants who were randomized and received at least 1 dose of the study drug with H pylori positive status at Baseline with data available for analyses. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Endoscopically Confirmed Healing of Duodenal Ulcer at Week 4 | Week 4 | FAS included all participants who were randomized and 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 Posttreatment Resolution of Gastrointestinal Symptoms Associated With Duodenal Ulcer at Weeks 2 Through 6 | Week 2 up to Week 6 | FAS included all participants who were randomized and received at least 1 dose of the study drug. Number analyzed is number of participants analyzed for the particular category (symptom). | 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 Duodenal Ulcers | TAK-438 20 mg | 96.9 | 95% Confidence Interval 93.889 to 98.631 | percentage of participants | |
| Percentage of Participants With Endoscopically Confirmed Healing of Duodenal Ulcers | Lansoprazole 30 mg | 96.5 | 95% Confidence Interval 93.406 to 98.374 | percentage of participants | |
| Percentage of Helicobacter Pylori Infected (HP+) Participants With Successful HP Eradication After 4 or 6 Weeks of Treatment | TAK-438 20 mg | 91.5 | 95% Confidence Interval 86.853 to 94.866 | percentage of participants | |
| Percentage of Helicobacter Pylori Infected (HP+) Participants With Successful HP Eradication After 4 or 6 Weeks of Treatment | Lansoprazole 30 mg | 86.8 | 95% Confidence Interval 81.330 to 91.093 | percentage of participants | |
| Percentage of Participants With Endoscopically Confirmed Healing of Duodenal Ulcer at Week 4 | TAK-438 20 mg | 89.2 | 95% Confidence Interval 84.617 to 92.731 | percentage of participants | |
| Percentage of Participants With Endoscopically Confirmed Healing of Duodenal Ulcer at Week 4 | Lansoprazole 30 mg | 88.4 | 95% Confidence Interval 83.830 to 92.124 | percentage of participants | |
| Percentage of Participants With Posttreatment Resolution of Gastrointestinal Symptoms Associated With Duodenal Ulcer at Weeks 2 Through 6 | TAK-438 20 mg | Epigastric Pain (Postprandial) | 87.7 | 95% Confidence Interval 76.321 to 94.917 | percentage of participants |
| Percentage of Participants With Posttreatment Resolution of Gastrointestinal Symptoms Associated With Duodenal Ulcer at Weeks 2 Through 6 | Lansoprazole 30 mg | Epigastric Pain (Postprandial) | 91.8 | 95% Confidence Interval 80.399 to 97.731 | percentage of participants |
| Percentage of Participants With Posttreatment Resolution of Gastrointestinal Symptoms Associated With Duodenal Ulcer at Weeks 2 Through 6 | TAK-438 20 mg | Epigastric Pain (Fasting/Nocturnal) | 91.7 | 95% Confidence Interval 85.579 to 95.767 | percentage of participants |
| Percentage of Participants With Posttreatment Resolution of Gastrointestinal Symptoms Associated With Duodenal Ulcer at Weeks 2 Through 6 | Lansoprazole 30 mg | Epigastric Pain (Fasting/Nocturnal) | 90.1 | 95% Confidence Interval 83.902 to 94.465 | 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 | 265 | |
| Overall Study | STARTED | Lansoprazole 30 mg | 268 | |
| Overall Study | COMPLETED | TAK-438 20 mg | 248 | |
| Overall Study | COMPLETED | Lansoprazole 30 mg | 248 | |
| Overall Study | NOT COMPLETED | TAK-438 20 mg | 17 | |
| Overall Study | NOT COMPLETED | Lansoprazole 30 mg | 20 |
Source ClinicalTrials.gov
Adverse events22
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 | Upper respiratory tract infection | Infections and infestations | TAK-438 20 mg | 21 | 263 | |
| other | Upper respiratory tract infection | Infections and infestations | Lansoprazole 30 mg | 37 | 268 | |
| other | Pepsinogen test positive | Investigations | TAK-438 20 mg | 124 | 263 | |
| other | Pepsinogen test positive | Investigations | Lansoprazole 30 mg | 28 | 268 | |
| other | Pepsinogen I increased | Investigations | TAK-438 20 mg | 92 | 263 | |
| other | Pepsinogen I increased | Investigations | Lansoprazole 30 mg | 37 | 268 | |
| other | Blood gastrin increased | Investigations | TAK-438 20 mg | 97 | 263 | |
| other | Blood gastrin increased | Investigations | Lansoprazole 30 mg | 20 | 268 | |
| other | Protein urine present | Investigations | TAK-438 20 mg | 20 | 263 | |
| other | Protein urine present | Investigations | Lansoprazole 30 mg | 11 | 268 |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 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 | 263 |
| Total, all-cause mortality | Lansoprazole 30 mg | 0 | 268 |
| Total, other adverse events | TAK-438 20 mg | 162 | 263 |
| Total, other adverse events | Lansoprazole 30 mg | 113 | 268 |
| Total, serious adverse events | TAK-438 20 mg | 1 | 263 |
| Total, serious adverse events | Lansoprazole 30 mg | 3 | 268 |
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/NCT03050359
GET https://conductscience.org/api/trials/v1/NCT03050359/events?page=2