Trial · NCT04124926
Efficacy and Safety of Vonoprazan Compared to Lansoprazole in Participants With Erosive Esophagitis
NCT04124926, Phase 3, Completed, Phathom Pharmaceuticals, Inc.; results first posted 2022-07-29
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety of Vonoprazan Compared to Lansoprazole in Participants With Erosive Esophagitis. Trials, record NCT04124926. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04124926
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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 Participants With Erosive Esophagitis
- NCT number
- NCT04124926
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,027 participants, actual
- Lead sponsor
- Phathom Pharmaceuticals, Inc.
- Conditions
- Erosive Esophagitis
- Interventions
- Vonoprazan, Lansoprazole
- First posted
- 2019-10-14
- Last updated
- 2022-07-29
- Other registries' IDs
- eudract:2019-002579-33
- Results first posted
- 2022-07-29
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Healing Phase: Percentage of Participants Who Had Complete Healing of EE by Week 8 | Week 8 | A participant was considered to have complete healing of EE if healing was demonstrated during endoscopy. |
| Primary | Maintenance Phase: Percentage of Participants Who Maintained Complete Healing of EE at Week 24 | Week 24 | A participant was considered to have complete healing of EE if healing was demonstrated during endoscopy. |
| Secondary | Healing Phase: Percentage of 24-hour Heartburn-free Days | Day 1 to Week 8 | A 24-hour heartburn-free day was defined as a day having no heartburn among all diary entries for that day. The percentage of 24-hour heartburn-free days was calculated using all days with at least 1 evening or morning diary entry during the treatment period of this phase. |
| Secondary | Healing Phase: Percentage of Participants With Baseline LA Classification Grades C or D Who Had Complete Healing of EE at Week 2 | Week 2 | A participant was considered to have complete healing of EE if healing was demonstrated during endoscopy. LA Classification of Esophagitis Grading Scale: Grade C: One or more mucosal breaks that are continuous between the tops of 2 or more mucosal folds, which involves less than 75% of the circumference. Grade D: One or more mucosal breaks, which involves at least 75% of the circumference. |
| Secondary | Healing Phase: Percentage of Participants With Onset of Sustained Resolution of Heartburn by Day 3 | Day 1 to maximum of Day 10 (inclusive of 7 day heartburn assessment) | Sustained resolution was defined as at least 7 consecutive days with no daytime or night time heartburn as assessed by the daily diary. A participant was considered to have sustained resolution of heartburn by Day 3 if the first day of the 7 consecutive days without symptoms was on Days 1, 2, or 3. |
| Secondary | Healing Phase: Percentage of Participants With Baseline LA Classification Grades C or D Who Had Complete Healing of EE by Week 8 | Week 8 | A participant was considered to have complete healing of EE if healing was demonstrated during endoscopy. LA Classification of Esophagitis Grading Scale: Grade C: One or more mucosal breaks that are continuous between the tops of 2 or more mucosal folds, which involves less than 75% of the circumference. Grade D: One or more mucosal breaks, which involves at least 75% of the circumference. |
| Secondary | Healing Phase: Percentage of Participants Who Had Complete Healing of EE at Week 2 | Week 2 | A participant was considered to have complete healing of EE if healing was demonstrated during endoscopy. |
| Secondary | Maintenance Phase: Percentage of Participants With Baseline LA Classification Grades C or D Who Maintained Complete Healing of EE at Week 24 | Week 24 | A participant was considered to have complete healing of EE if healing was demonstrated during endoscopy. LA Classification of Esophagitis Grading Scale: Grade C: One or more mucosal breaks that are continuous between the tops of 2 or more mucosal folds, which involves less than 75% of the circumference. Grade D: One or more mucosal breaks, which involves at least 75% of the circumference. |
| Secondary | Maintenance Phase: Percentage of 24-hour Heartburn-free Days | Day 1 to Week 24 | A 24-hour heartburn-free day was defined as a day having no heartburn among all diary entries for that day. The percentage of 24-hour heartburn-free days was calculated using all days with at least 1 evening or morning diary entry during the treatment period of this phase. |
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 | Healing Phase: Percentage of Participants Who Had Complete Healing of EE by Week 8 | Week 8 | The Modified Intent-to-Treat (MITT) Set (Healing Phase) included all participants randomized into the Healing Phase who had documented EE at baseline and received at least 1 dose of study drug during the Healing Phase. All analyses using the MITT Set grouped subjects according to the randomized treatment. | percentage of participants | NUMBER |
| PRIMARY | Maintenance Phase: Percentage of Participants Who Maintained Complete Healing of EE at Week 24 | Week 24 | The MITT Set (Maintenance Phase) included all participants randomized into the Maintenance Phase who had healed EE at the end of the Healing Phase and received at least 1 dose of study drug during the Maintenance Phase. All analyses using the MITT Set grouped participants according to the randomized treatment. | percentage of participants | NUMBER |
| SECONDARY | Healing Phase: Percentage of 24-hour Heartburn-free Days | Day 1 to Week 8 | The MITT Set (Healing Phase) including only participants with at least one heartburn diary entry. | percentage of days | MEAN |
| SECONDARY | Healing Phase: Percentage of Participants With Baseline LA Classification Grades C or D Who Had Complete Healing of EE at Week 2 | Week 2 | The MITT Set (Healing Phase) including only participants with baseline LA Classification Grades C or D. | percentage of participants | NUMBER |
| SECONDARY | Healing Phase: Percentage of Participants With Onset of Sustained Resolution of Heartburn by Day 3 | Day 1 to maximum of Day 10 (inclusive of 7 day heartburn assessment) | The MITT Set (Healing Phase) included all participants randomized into the Healing Phase who had documented EE at baseline and received at least 1 dose of study drug during the Healing Phase. All analyses using the MITT Set grouped subjects according to the randomized treatment. | percentage of participants | NUMBER |
| SECONDARY | Healing Phase: Percentage of Participants With Baseline LA Classification Grades C or D Who Had Complete Healing of EE by Week 8 | Week 8 | The MITT Set (Healing Phase) including only participants with baseline LA Classification Grades C or D. | percentage of participants | NUMBER |
| SECONDARY | Healing Phase: Percentage of Participants Who Had Complete Healing of EE at Week 2 | Week 2 | The MITT Set (Healing Phase) included all participants randomized into the Healing Phase who had documented EE at baseline and received at least 1 dose of study drug during the Healing Phase. All analyses using the MITT Set grouped subjects according to the randomized treatment. | percentage of participants | NUMBER |
| SECONDARY | Maintenance Phase: Percentage of Participants With Baseline LA Classification Grades C or D Who Maintained Complete Healing of EE at Week 24 | Week 24 | The MITT Set (Maintenance Phase) including only participants with baseline LA Classification Grades C or D with nonmissing data. | percentage of participants | NUMBER |
| SECONDARY | Maintenance Phase: Percentage of 24-hour Heartburn-free Days | Day 1 to Week 24 | The MITT Set (Maintenance Phase) including only participants with at least one heartburn diary entry. | percentage of days | MEAN |
Source ClinicalTrials.gov
Results by group21
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Healing Phase: Percentage of Participants Who Had Complete Healing of EE by Week 8 | Healing Phase: Vonoprazan 20 mg | 92.9 | percentage of participants | ||
| Healing Phase: Percentage of Participants Who Had Complete Healing of EE by Week 8 | Healing Phase: Lansoprazole 30 mg | 84.6 | percentage of participants | ||
| Maintenance Phase: Percentage of Participants Who Maintained Complete Healing of EE at Week 24 | Maintenance Phase: Vonoprazan 10 mg | 79.2 | percentage of participants | ||
| Maintenance Phase: Percentage of Participants Who Maintained Complete Healing of EE at Week 24 | Maintenance Phase: Vonoprazan 20 mg | 80.7 | percentage of participants | ||
| Maintenance Phase: Percentage of Participants Who Maintained Complete Healing of EE at Week 24 | Maintenance Phase: Lansoprazole 15 mg | 72.0 | percentage of participants | ||
| Healing Phase: Percentage of 24-hour Heartburn-free Days | Healing Phase: Vonoprazan 20 mg | 66.8 | Standard Deviation 34.60 | percentage of days | |
| Healing Phase: Percentage of 24-hour Heartburn-free Days | Healing Phase: Lansoprazole 30 mg | 64.1 | Standard Deviation 35.46 | percentage of days | |
| Healing Phase: Percentage of Participants With Baseline LA Classification Grades C or D Who Had Complete Healing of EE at Week 2 | Healing Phase: Vonoprazan 20 mg | 70.2 | percentage of participants | ||
| Healing Phase: Percentage of Participants With Baseline LA Classification Grades C or D Who Had Complete Healing of EE at Week 2 | Healing Phase: Lansoprazole 30 mg | 52.6 | percentage of participants | ||
| Healing Phase: Percentage of Participants With Onset of Sustained Resolution of Heartburn by Day 3 | Healing Phase: Vonoprazan 20 mg | 34.4 | percentage of participants |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 results by groupParticipant flow40
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Healing Phase | STARTED | Healing Phase: Vonoprazan 20 mg | 514 | |
| Healing Phase | STARTED | Healing Phase: Lansoprazole 30 mg | 513 | |
| Healing Phase | STARTED | Maintenance Phase: Vonoprazan 10 mg | 0 | |
| Healing Phase | STARTED | Maintenance Phase: Vonoprazan 20 mg | 0 | |
| Healing Phase | STARTED | Maintenance Phase: Lansoprazole 15 mg | 0 | |
| Healing Phase | Treated With Study Drug | Healing Phase: Vonoprazan 20 mg | 514 | |
| Healing Phase | Treated With Study Drug | Healing Phase: Lansoprazole 30 mg | 510 | |
| Healing Phase | Treated With Study Drug | Maintenance Phase: Vonoprazan 10 mg | 0 | |
| Healing Phase | Treated With Study Drug | Maintenance Phase: Vonoprazan 20 mg | 0 | |
| Healing Phase | Treated With Study Drug | Maintenance Phase: Lansoprazole 15 mg | 0 |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 participant flowAdverse events240
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 | Healing Phase: Vonoprazan 20 mg | 11 | 514 | 11 |
| other | Diarrhoea | Gastrointestinal disorders | Healing Phase: Lansoprazole 30 mg | 13 | 510 | 13 |
| other | Diarrhoea | Gastrointestinal disorders | Maintenance Phase: Vonoprazan 10 mg | 3 | 296 | 3 |
| other | Diarrhoea | Gastrointestinal disorders | Maintenance Phase: Vonoprazan 20 mg | 7 | 296 | 7 |
| other | Diarrhoea | Gastrointestinal disorders | Maintenance Phase: Lansoprazole 15 mg | 13 | 297 | 14 |
| other | Abdominal pain | Gastrointestinal disorders | Healing Phase: Vonoprazan 20 mg | 8 | 514 | 9 |
| other | Abdominal pain | Gastrointestinal disorders | Healing Phase: Lansoprazole 30 mg | 2 | 510 | 2 |
| other | Abdominal pain | Gastrointestinal disorders | Maintenance Phase: Vonoprazan 10 mg | 4 | 296 | 4 |
| other | Abdominal pain | Gastrointestinal disorders | Maintenance Phase: Vonoprazan 20 mg | 10 | 296 | 12 |
| other | Abdominal pain | Gastrointestinal disorders | Maintenance Phase: Lansoprazole 15 mg | 3 | 297 | 3 |
1 to 10 of 240Source ClinicalTrials.gov
See all 240 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Healing Phase: Vonoprazan 20 mg | 0 | 514 |
| Total, all-cause mortality | Healing Phase: Lansoprazole 30 mg | 0 | 510 |
| Total, all-cause mortality | Maintenance Phase: Vonoprazan 10 mg | 0 | 296 |
| Total, all-cause mortality | Maintenance Phase: Vonoprazan 20 mg | 2 | 296 |
| Total, all-cause mortality | Maintenance Phase: Lansoprazole 15 mg | 0 | 297 |
| Total, other adverse events | Healing Phase: Vonoprazan 20 mg | 50 | 514 |
| Total, other adverse events | Healing Phase: Lansoprazole 30 mg | 46 | 510 |
| Total, other adverse events | Maintenance Phase: Vonoprazan 10 mg | 72 | 296 |
| Total, other adverse events | Maintenance Phase: Vonoprazan 20 mg | 81 | 296 |
| Total, other adverse events | Maintenance Phase: Lansoprazole 15 mg | 74 | 297 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 36228734 | 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
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The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04124926
GET https://conductscience.org/api/trials/v1/NCT04124926/results?page=2