Erosive Esophagitis
Conditions
Keywords
Esophagitis
Brief summary
The purpose of this study is exploratorily evaluate the effect on gastric mucosal tissue and the safety of long-term administration (260 weeks: 5 years) of vonoprazan 10 mg or 20 mg in patients receiving maintenance treatment after healed erosive esophagitis (EE), and the curative effect of vonoprazan 20 mg versus lansoprazole in patients with EE.
Detailed description
This is a multicenter, open-label, randomized, parallel-group study to exploratorily evaluate the effect on gastric mucosal tissue and the safety of long-term administration of vonoprazan in maintenance treatment after healed EE, and the curative effect of vonoprazan versus lansoprazole in participants with EE. Participants endoscopically diagnosed with EE of Los Angeles (LA) Classification Grades A to D at the start of treatment (Week 0 of the healing phase) will be randomly assigned to receive either vonoprazan 20 mg or lansoprazole 30 mg to be taken once daily for up to 8 weeks. Subjects with healed EE as confirmed endoscopically at Week 4 or 8 in the healing phase will enter the maintenance phase. In the maintenance phase, the vonoprazan group and the lansoprazole group will be administered a starting dose of 10 mg and 15 mg, respectively, once daily up to 260 weeks. If the principal investigator or investigator judged the effect of vonoprazan 10 mg or lansoprazole 15 mg to be insufficient as the maintenance treatment of EE, vonoprazan and lansoprazole may be increased to 20 mg and 30 mg, respectively. The research period will consist of two subperiods: healing phase in which participants with EE will receive treatment (for 4 or 8 weeks) and maintenance phase in which participants will receive maintenance treatment (for 260 weeks), and thus, a total of up to 268 weeks. The number of visits will be a maximum of 18 visits. Planned number of research subjects, as the number of research subjects for entry to the maintenance phase, will be 130 participants in the vonoprazan group and 65 participants in the lansoprazole group.
Interventions
DRUGVonoprazan
Vonoprazan fumarate 10 mg or 20 mg capsules
DRUGLansoprazole
Lansoprazole 15 mg or 30 mg capsules
Sponsors
Takeda
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Healing Phase: 1. Participants endoscopically diagnosed with EE of grades A to D by the LA Classification Grading System at the start of treatment (Week 0 of the healing phase) 2. Participants with H. pylori negative 3. Participants who, in the opinion of the principal investigator or investigator, are capable of understanding the content of the clinical research and complying with the research protocol requirements. 4. Participants who can sign and date an informed consent form and information sheet prior to the conduction of the clinical research procedures. 5. Male or female participants aged 20 years or older at the time of informed consent 6. Therapeutic category: Ambulatory Maintenance Phase: 7. Participants who have endoscopically confirmed EE healing\* (mucous membrane disorder is not observed) at completion of the healing phase (Week 4 or 8 of the healing phase) \* Participants who are classified as grade 0 according to severity classification of EE (See Table 9.b) 8. Participants who have been determined to be appropriate as subjects for maintenance treatment of EE by the principal investigator or investigator
Exclusion criteria
Healing Phase: 1. Participants with concurrent peptic ulcer (except scarred stage) or Zollinger-Ellison syndrome 2. Participants who received treatment with PPIs (including vonoprazan) within 4 weeks (Week -4 to Week 0) prior to the start of healing phase (Week 0 of the healing phase) 3. Participants with a history of H. pylori eradication. 4. Participants who have received surgery or treatment affecting gastroesophageal reflux (fundoplication or dilation for esophageal stenosis \[excluding Schatzki's ring\], etc.) 5. Participants with an esophagus-related complication (eosinophilic esophagitis, esophageal varices, scleroderma, viral or fungal infection, esophageal stenosis, etc.), a history of radiotherapy or cryotherapy of the esophagus, a caustic or physiochemical trauma (esophageal sclerotherapy, etc.). However, participants with Schatzki's ring (mucosal tissue ring around inferior esophageal sphincter) or Barrett's esophagus are allowed to be included. 6. Participants with clinically apparent hepatic impairment (e.g., AST or ALT levels at the time of informed consent: \>1.5 times the upper limit of normal (ULN). 7. Participants with renal impairment or renal failure \[creatinine clearance (CCr) ˂30 mL/min, etc.\] 8. Participants with a history of hypersensitivity or allergy for PPIs. 9. Participants with a history of gastrectomy, gastrointestinal resection, or vagotomy 10. Participants with a malignant tumor 11. Participants who are pregnant, breast-feeding, possibly pregnant, or planning to become pregnant 12. Participants with one of the diseases listed under administration contraindication in the vonoprazan or lansoprazole package insert 13. Participants planning to take prohibited concomitant medications during the research period 14. Participants participating in other clinical studies 15. Participants who have been determined to be inappropriate as subjects in the study by the principal investigator or investigator Maintenance Phase: 16. Participants who have taken PPIs other than the study drug or the control drug during the healing phase 17. Participants who have been determined to be inappropriate as subjects in the study by the principal investigator or investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Malignant Alteration of Epithelial Cells | Time Frame: Up to Week 268 (Week 260 in Maintenance Phase) | Numbers of participants with malignant alteration of epithelial cells for Vonoprazan group and Lansoprazole group at Week 268 (Week 260 in Maintenance Phase) were reported as the endpoint for gastric mucosa histopathology. The number analyzed is the number of participants with data available for analysis. |
| Number of Participants With Parietal Cell Protrusion/Hyperplasia | Up to Week 268 (Week 260 in Maintenance Phase) | Numbers of participants with parietal cell protrusion/hyperplasia for Vonoprazan group and Lansoprazole group at Week 268 (Week 260 in Maintenance Phase) were reported as the endpoint for gastric mucosa histopathology. The number analyzed is the number of participants with data available for analysis. |
| Number of Participants With Foveolar Hyperplasia | Up to Week 268 (Week 260 in Maintenance Phase) | Numbers of participants with foveolar hyperplasia for Vonoprazan group and Lansoprazole group at Week 268 (Week 260 in Maintenance Phase) were reported as the endpoint for gastric mucosa histopathology. The number analyzed is the number of participants with data available for analysis. |
| Number of Participants With Enterochromaffin-like-cell Hyperplasia | Up to Week 268 (Week 260 in Maintenance Phase) | Numbers of participants with enterochromaffin-like-cell hyperplasia for Vonoprazan group and Lansoprazole group at Week 268 (Week 260 in Maintenance Phase) were reported as the endpoint for gastric mucosa histopathology. The number analyzed is the number of participants with data available for analysis. |
| Number of Participants With G-cell Hyperplasia | Up to Week 268 (Week 260 in Maintenance Phase) | Numbers of participants with G-cell hyperplasia for Vonoprazan group and Lansoprazole group at Week 268 (Week 260 in Maintenance Phase) were reported as the endpoint for gastric mucosa histopathology. The number analyzed is the number of participants with data available for analysis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Cobblestone Mucosa | Up to Week 268 (Week 260 in Maintenance Phase) | Numbers of participants with cobblestone mucosa for Vonoprazan group and Lansoprazole group at Week 268 (Week 260 in Maintenance Phase) were reported as the endpoint for endoscopic findings. The number analyzed is the number of participants with data available for analysis. |
| Number of Participants With Multiple White and Flat Elevated Lesions | Up to Week 268 (Week 260 in Maintenance Phase) | Numbers of participants with multiple white and flat elevated lesions for Vonoprazan group and Lansoprazole group at Week 268 (Week 260 in Maintenance Phase) were reported as the endpoint for endoscopic findings. The number analyzed is the number of participants with data available for analysis. |
| Number of Participants With Black Spots | Up to Week 268 (Week 260 in Maintenance Phase) | Numbers of participants with black spots for Vonoprazan group and Lansoprazole group at Week 268 (Week 260 in Maintenance Phase) were reported as the endpoint for endoscopic findings. The number analyzed is the number of participants with data available for analysis. |
| Number of Participants With Inflammation (Mononuclear Infiltration) in Greater Curvature of Middle Gastric Body | Up to Week 268 (Week 260 in Maintenance Phase) | Numbers of participants with inflammation (mononuclear infiltration) in greater curvature of the middle gastric body for Vonoprazan group and Lansoprazole group at Week 268 (Week 260 in Maintenance Phase) were reported as histological assessment of gastritis. |
| Number of Participants With Inflammation (Mononuclear Infiltration) in Greater Curvature of Antrum | Up to Week 268 (Week 260 in Maintenance Phase) | Numbers of participants with inflammation (mononuclear infiltration) in greater curvature of the antrum for Vonoprazan group and Lansoprazole group at Week 268 (Week 260 in Maintenance Phase) were reported as histological assessment of gastritis. |
| Number of Participants With Neutrophilic Infiltration in Greater Curvature of Middle Gastric Body | Up to Week 268 (Week 260 in Maintenance Phase) | Numbers of participants with neutrophilic infiltration in greater curvature of the middle gastric body for Vonoprazan group and Lansoprazole group at Week 268 (Week 260 in Maintenance Phase) were reported as histological assessment of gastritis. |
| Number of Participants With Neutrophilic Infiltration in Greater Curvature of Antrum | Up to Week 268 (Week 260 in Maintenance Phase) | Numbers of participants with neutrophilic infiltration in greater curvature of the antrum for Vonoprazan group and Lansoprazole group at Week 268 (Week 260 in Maintenance Phase) were reported as histological assessment of gastritis. |
| Percentage of Participants With Recurrence of Erosive Esophagitis (EE) | Up to Week 268 (Week 260 in Maintenance Phase) | Erosive esophagitis recurrence is defined as endoscopically confirmed to have erosive esophagitis (LA classification grades O and A to D) during the Maintenance Phase. The LA classification graded as follows- Grade O: normal mucosa; Grade A: nonconfluent mucosal breaks \<5 mm in length; Grade B: nonconfluent mucosal breaks ≥ 5mm in length; Grade C: confluent mucosal breaks \<75% circumferential; Grade D: confluent mucosal breaks \>75% circumferential. |
| Number of Participants With Atrophy in Greater Curvature of Antrum | Up to Week 268 (Week 260 in Maintenance Phase) | Numbers of participants with atrophy in greater curvature of the antrum for Vonoprazan group and Lansoprazole group at Week 268 (Week 260 in Maintenance Phase) were reported as histological assessment of gastritis. |
| Number of Participants With Intestinal Metaplasia in Greater Curvature of Middle Gastric Body | Up to Week 268 (Week 260 in Maintenance Phase) | Numbers of participants with intestinal metaplasia in greater curvature of the middle gastric body for Vonoprazan group and Lansoprazole group at Week 268 (Week 260 in Maintenance Phase) were reported as histological assessment of gastritis. |
| Number of Participants With Intestinal Metaplasia in Greater Curvature of Antrum | Up to Week 268 (Week 260 in Maintenance Phase) | Numbers of participants with intestinal metaplasia in greater curvature of the antrum for Vonoprazan group and Lansoprazole group at Week 268 (Week 260 in Maintenance Phase) were reported as histological assessment of gastritis. |
| Number of Participants With Presence of H.Pylori in Greater Curvature of Middle Gastric Body | Up to Week 268 (Week 260 in Maintenance Phase) | Numbers of participants with presence of H.pylori in greater curvature of the middle gastric body for Vonoprazan group and Lansoprazole group at Week 268 (Week 260 in Maintenance Phase) were reported as histological assessment of gastritis. |
| Number of Participants With Presence of H.Pylori in Greater Curvature of Antrum | Up to Week 268 (Week 260 in Maintenance Phase) | Numbers of participants with presence of H.pylori in greater curvature of the antrum for Vonoprazan group and Lansoprazole group at Week 268 (Week 260 in Maintenance Phase) were reported as histological assessment of gastritis. |
| Number of Participants With Gastric Polyp | Up to Week 268 (Week 260 in Maintenance Phase) | Numbers of participants with gastric polyp for Vonoprazan group and Lansoprazole group at Week 268 (Week 260 in Maintenance Phase) were reported. The number analyzed is the number of participants with data available for analysis. |
| Number of Participants With Atrophy in Greater Curvature of Middle Gastric Body | Up to Week 268 (Week 260 in Maintenance Phase) | Numbers of participants with atrophy in greater curvature of the middle gastric body for Vonoprazan group and Lansoprazole group at Week 268 (Week 260 in Maintenance Phase) were reported as histological assessment of gastritis. |
| Percentage of Participants Who Healed EE at the End of Healing Phase | Up to Week 8 | Percentage of participants who healed EE at the end of healing phase was reported. |
| Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) in Maintenance Phase | 260 weeks (Baseline, up to the end of Maintenance Phase) | Number of participants reporting one or more TEAEs in Maintenance Phase was reported. An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; 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. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug. |
| Number of Participants With Fundic Gland Polyp | Up to Week 268 (Week 260 in Maintenance Phase) | Numbers of participants with fundic gland polyp for Vonoprazan group and Lansoprazole group at Week 268 (Week 260 in Maintenance Phase) were reported as the endpoint for endoscopic findings. The number analyzed is the number of participants with data available for analysis. |
| Number of Participants With Hyperplastic Polyp | Up to Week 268 (Week 260 in Maintenance Phase) | Numbers of participants with hyperplastic polyp for Vonoprazan group and Lansoprazole group at Week 268 (Week 260 in Maintenance Phase) were reported as the endpoint for endoscopic findings. The number analyzed is the number of participants with data available for analysis. |
Countries
Japan
Participant flow
Recruitment details
Participants took part in the survey at 36 investigative sites in Japan, from 20 March 2016 to 5 March 2022.
Pre-assignment details
Participants with a historical diagnosis of erosive esophagitis were enrolled. Participants received Vonoprazan or Lansoprazole as part of a routine medical care.
Participants by arm
| Arm | Count |
|---|---|
| Vonoprazan Group Vonoprazan 20 mg administered orally once daily in the healing phase, after that Vonoprazan 10 mg (as the initial dose and adjusted to Vonoprazan 10 mg or 20 mg) administered orally once daily in the maintenance phase. | 139 |
| Lansoprazole Group Lansoprazole 30 mg administered orally once daily in the healing phase, after that Lansoprazole 15 mg (as the initial dose and adjusted to Lansoprazole 15 mg or 30 mg) administered orally once daily in the maintenance phase. | 69 |
| Total | 208 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Healing Phase | Lost to Follow-up | 1 | 0 |
| Healing Phase | Protocol Violation | 1 | 1 |
| Maintenance Phase | Adverse Event | 12 | 2 |
| Maintenance Phase | Lost to Follow-up | 0 | 1 |
| Maintenance Phase | Other | 5 | 4 |
| Maintenance Phase | Withdrawal by Subject | 15 | 8 |
Baseline characteristics
| Characteristic | Vonoprazan Group | Lansoprazole Group | Total |
|---|---|---|---|
| Age, Continuous | 60.5 years STANDARD_DEVIATION 11.9 | 61.8 years STANDARD_DEVIATION 12.13 | 60.9 years STANDARD_DEVIATION 11.97 |
| BMI (Body Mass Index) | 25.25 Kilogram (kg)/meter (m)^2 STANDARD_DEVIATION 3.737 | 24.85 Kilogram (kg)/meter (m)^2 STANDARD_DEVIATION 3.28 | 25.12 Kilogram (kg)/meter (m)^2 STANDARD_DEVIATION 3.589 |
| Consumption of Caffeine-Containing Beverage No | 27 Participants | 19 Participants | 46 Participants |
| Consumption of Caffeine-Containing Beverage Yes | 112 Participants | 50 Participants | 162 Participants |
| Drinking History Drinks a Few Days per Month | 22 Participants | 19 Participants | 41 Participants |
| Drinking History Drinks a Few Days per Week | 27 Participants | 16 Participants | 43 Participants |
| Drinking History Drinks Every Day | 44 Participants | 17 Participants | 61 Participants |
| Drinking History Never Drank or Ex Drinker | 46 Participants | 17 Participants | 63 Participants |
| Endoscopic Findings in Esophagus Grade A | 64 Participants | 33 Participants | 97 Participants |
| Endoscopic Findings in Esophagus Grade B | 50 Participants | 25 Participants | 75 Participants |
| Endoscopic Findings in Esophagus Grade C | 20 Participants | 10 Participants | 30 Participants |
| Endoscopic Findings in Esophagus Grade D | 5 Participants | 1 Participants | 6 Participants |
| Height | 164.4 Centimeters (cm) STANDARD_DEVIATION 8.96 | 162.7 Centimeters (cm) STANDARD_DEVIATION 10.12 | 163.8 Centimeters (cm) STANDARD_DEVIATION 9.37 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment Japan | 139 Participants | 69 Participants | 208 Participants |
| Serum Gastrin Level | 130.2 Picogram/milliliter (pg/mL) STANDARD_DEVIATION 77.97 | 155.1 Picogram/milliliter (pg/mL) STANDARD_DEVIATION 128.73 | 138.5 Picogram/milliliter (pg/mL) STANDARD_DEVIATION 98.15 |
| Serum Pepsinogen I/II Ratio | 5.45 Ratio STANDARD_DEVIATION 1.226 | 5.24 Ratio STANDARD_DEVIATION 1.314 | 5.38 Ratio STANDARD_DEVIATION 1.257 |
| Sex: Female, Male Female | 41 Participants | 27 Participants | 68 Participants |
| Sex: Female, Male Male | 98 Participants | 42 Participants | 140 Participants |
| Smoking History Current Smoker | 25 Participants | 9 Participants | 34 Participants |
| Smoking History Ex-Smoker | 62 Participants | 29 Participants | 91 Participants |
| Smoking History Never Smoked | 52 Participants | 31 Participants | 83 Participants |
| Weight | 68.55 Kilograms (kg) STANDARD_DEVIATION 13.011 | 65.98 Kilograms (kg) STANDARD_DEVIATION 11.52 | 67.70 Kilograms (kg) STANDARD_DEVIATION 12.566 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 139 | 1 / 69 |
| other Total, other adverse events | 128 / 139 | 65 / 69 |
| serious Total, serious adverse events | 50 / 139 | 27 / 69 |
Outcome results
Primary
Number of Participants With Enterochromaffin-like-cell Hyperplasia
Numbers of participants with enterochromaffin-like-cell hyperplasia for Vonoprazan group and Lansoprazole group at Week 268 (Week 260 in Maintenance Phase) were reported as the endpoint for gastric mucosa histopathology. The number analyzed is the number of participants with data available for analysis.
Time frame: Up to Week 268 (Week 260 in Maintenance Phase)
Population: Safety Data Analysis Set in the Maintenance Phase: All participants who were enrolled in Maintenance Phase and who received at least one dose of any therapy in the Maintenance Phase of this study. The number analyzed is the number of participants with data available for analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Vonoprazan Group | Number of Participants With Enterochromaffin-like-cell Hyperplasia | 5 Participants |
| Lansoprazole Group | Number of Participants With Enterochromaffin-like-cell Hyperplasia | 4 Participants |
Primary
Number of Participants With Foveolar Hyperplasia
Numbers of participants with foveolar hyperplasia for Vonoprazan group and Lansoprazole group at Week 268 (Week 260 in Maintenance Phase) were reported as the endpoint for gastric mucosa histopathology. The number analyzed is the number of participants with data available for analysis.
Time frame: Up to Week 268 (Week 260 in Maintenance Phase)
Population: Safety Data Analysis Set in the Maintenance Phase: All participants who were enrolled in Maintenance Phase and who received at least one dose of any therapy in the Maintenance Phase of this study. The number analyzed is the number of participants with data available for analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Vonoprazan Group | Number of Participants With Foveolar Hyperplasia | 15 Participants |
| Lansoprazole Group | Number of Participants With Foveolar Hyperplasia | 1 Participants |
Primary
Number of Participants With G-cell Hyperplasia
Numbers of participants with G-cell hyperplasia for Vonoprazan group and Lansoprazole group at Week 268 (Week 260 in Maintenance Phase) were reported as the endpoint for gastric mucosa histopathology. The number analyzed is the number of participants with data available for analysis.
Time frame: Up to Week 268 (Week 260 in Maintenance Phase)
Population: Safety Data Analysis Set in the Maintenance Phase: All participants who were enrolled in Maintenance Phase and who received at least one dose of any therapy in the Maintenance Phase of this study. The number analyzed is the number of participants with data available for analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Vonoprazan Group | Number of Participants With G-cell Hyperplasia | 87 Participants |
| Lansoprazole Group | Number of Participants With G-cell Hyperplasia | 40 Participants |
Primary
Number of Participants With Malignant Alteration of Epithelial Cells
Numbers of participants with malignant alteration of epithelial cells for Vonoprazan group and Lansoprazole group at Week 268 (Week 260 in Maintenance Phase) were reported as the endpoint for gastric mucosa histopathology. The number analyzed is the number of participants with data available for analysis.
Time frame: Time Frame: Up to Week 268 (Week 260 in Maintenance Phase)
Population: Safety Data Analysis Set in the Maintenance Phase: All participants who were enrolled in Maintenance Phase and who received at least one dose of any therapy in the Maintenance Phase of this study. The number analyzed is the number of participants with data available for analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Vonoprazan Group | Number of Participants With Malignant Alteration of Epithelial Cells | 0 Participants |
| Lansoprazole Group | Number of Participants With Malignant Alteration of Epithelial Cells | 0 Participants |
Primary
Number of Participants With Parietal Cell Protrusion/Hyperplasia
Numbers of participants with parietal cell protrusion/hyperplasia for Vonoprazan group and Lansoprazole group at Week 268 (Week 260 in Maintenance Phase) were reported as the endpoint for gastric mucosa histopathology. The number analyzed is the number of participants with data available for analysis.
Time frame: Up to Week 268 (Week 260 in Maintenance Phase)
Population: Safety Data Analysis Set in the Maintenance Phase: All participants who were enrolled in Maintenance Phase and who received at least one dose of any therapy in the Maintenance Phase of this study. The number analyzed is the number of participants with data available for analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Vonoprazan Group | Number of Participants With Parietal Cell Protrusion/Hyperplasia | 99 Participants |
| Lansoprazole Group | Number of Participants With Parietal Cell Protrusion/Hyperplasia | 45 Participants |
Secondary
Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) in Maintenance Phase
Number of participants reporting one or more TEAEs in Maintenance Phase was reported. An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; 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. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug.
Time frame: 260 weeks (Baseline, up to the end of Maintenance Phase)
Population: Safety Data Analysis Set in the Maintenance Phase: All participants who were enrolled in Maintenance Phase and who received at least one dose of any therapy in the Maintenance Phase of this study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Vonoprazan Group | Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) in Maintenance Phase | 126 Participants |
| Lansoprazole Group | Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) in Maintenance Phase | 64 Participants |
Secondary
Number of Participants With Atrophy in Greater Curvature of Antrum
Numbers of participants with atrophy in greater curvature of the antrum for Vonoprazan group and Lansoprazole group at Week 268 (Week 260 in Maintenance Phase) were reported as histological assessment of gastritis.
Time frame: Up to Week 268 (Week 260 in Maintenance Phase)
Population: Safety Data Analysis Set in the Maintenance Phase: All participants who were enrolled in Maintenance Phase and who received at least one dose of any therapy in the Maintenance Phase of this study. The number analyzed is the number of participants with data available for analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Vonoprazan Group | Number of Participants With Atrophy in Greater Curvature of Antrum | 7 Participants |
| Lansoprazole Group | Number of Participants With Atrophy in Greater Curvature of Antrum | 7 Participants |
Secondary
Number of Participants With Atrophy in Greater Curvature of Middle Gastric Body
Numbers of participants with atrophy in greater curvature of the middle gastric body for Vonoprazan group and Lansoprazole group at Week 268 (Week 260 in Maintenance Phase) were reported as histological assessment of gastritis.
Time frame: Up to Week 268 (Week 260 in Maintenance Phase)
Population: Safety Data Analysis Set in the Maintenance Phase: All participants who were enrolled in Maintenance Phase and who received at least one dose of any therapy in the Maintenance Phase of this study. The number analyzed is the number of participants with data available for analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Vonoprazan Group | Number of Participants With Atrophy in Greater Curvature of Middle Gastric Body | 0 Participants |
| Lansoprazole Group | Number of Participants With Atrophy in Greater Curvature of Middle Gastric Body | 0 Participants |
Secondary
Number of Participants With Black Spots
Numbers of participants with black spots for Vonoprazan group and Lansoprazole group at Week 268 (Week 260 in Maintenance Phase) were reported as the endpoint for endoscopic findings. The number analyzed is the number of participants with data available for analysis.
Time frame: Up to Week 268 (Week 260 in Maintenance Phase)
Population: Safety Data Analysis Set in the Maintenance Phase: All participants who were enrolled in Maintenance Phase and who received at least one dose of any therapy in the Maintenance Phase of this study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Vonoprazan Group | Number of Participants With Black Spots | 8 Participants |
| Lansoprazole Group | Number of Participants With Black Spots | 7 Participants |
Secondary
Number of Participants With Cobblestone Mucosa
Numbers of participants with cobblestone mucosa for Vonoprazan group and Lansoprazole group at Week 268 (Week 260 in Maintenance Phase) were reported as the endpoint for endoscopic findings. The number analyzed is the number of participants with data available for analysis.
Time frame: Up to Week 268 (Week 260 in Maintenance Phase)
Population: Safety Data Analysis Set in the Maintenance Phase: All participants who were enrolled in Maintenance Phase and who received at least one dose of any therapy in the Maintenance Phase of this study. The number analyzed is the number of participants with data available for analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Vonoprazan Group | Number of Participants With Cobblestone Mucosa | 23 Participants |
| Lansoprazole Group | Number of Participants With Cobblestone Mucosa | 8 Participants |
Secondary
Number of Participants With Fundic Gland Polyp
Numbers of participants with fundic gland polyp for Vonoprazan group and Lansoprazole group at Week 268 (Week 260 in Maintenance Phase) were reported as the endpoint for endoscopic findings. The number analyzed is the number of participants with data available for analysis.
Time frame: Up to Week 268 (Week 260 in Maintenance Phase)
Population: Safety Data Analysis Set in the Maintenance Phase: All participants who were enrolled in Maintenance Phase and who received at least one dose of any therapy in the Maintenance Phase of this study. The number analyzed is the number of participants with data available for analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Vonoprazan Group | Number of Participants With Fundic Gland Polyp | 75 Participants |
| Lansoprazole Group | Number of Participants With Fundic Gland Polyp | 45 Participants |
Secondary
Number of Participants With Gastric Polyp
Numbers of participants with gastric polyp for Vonoprazan group and Lansoprazole group at Week 268 (Week 260 in Maintenance Phase) were reported. The number analyzed is the number of participants with data available for analysis.
Time frame: Up to Week 268 (Week 260 in Maintenance Phase)
Population: Safety Data Analysis Set in the Maintenance Phase: All participants who were enrolled in Maintenance Phase and who received at least one dose of any therapy in the Maintenance Phase of this study. The number analyzed is the number of participants with data available for analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Vonoprazan Group | Number of Participants With Gastric Polyp | 82 Participants |
| Lansoprazole Group | Number of Participants With Gastric Polyp | 46 Participants |
Secondary
Number of Participants With Hyperplastic Polyp
Numbers of participants with hyperplastic polyp for Vonoprazan group and Lansoprazole group at Week 268 (Week 260 in Maintenance Phase) were reported as the endpoint for endoscopic findings. The number analyzed is the number of participants with data available for analysis.
Time frame: Up to Week 268 (Week 260 in Maintenance Phase)
Population: Safety Data Analysis Set in the Maintenance Phase: All participants who were enrolled in Maintenance Phase and who received at least one dose of any therapy in the Maintenance Phase of this study. The number analyzed is the number of participants with data available for analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Vonoprazan Group | Number of Participants With Hyperplastic Polyp | 24 Participants |
| Lansoprazole Group | Number of Participants With Hyperplastic Polyp | 6 Participants |
Secondary
Number of Participants With Inflammation (Mononuclear Infiltration) in Greater Curvature of Antrum
Numbers of participants with inflammation (mononuclear infiltration) in greater curvature of the antrum for Vonoprazan group and Lansoprazole group at Week 268 (Week 260 in Maintenance Phase) were reported as histological assessment of gastritis.
Time frame: Up to Week 268 (Week 260 in Maintenance Phase)
Population: Safety Data Analysis Set in the Maintenance Phase: All participants who were enrolled in Maintenance Phase and who received at least one dose of any therapy in the Maintenance Phase of this study. The number analyzed is the number of participants with data available for analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Vonoprazan Group | Number of Participants With Inflammation (Mononuclear Infiltration) in Greater Curvature of Antrum | 11 Participants |
| Lansoprazole Group | Number of Participants With Inflammation (Mononuclear Infiltration) in Greater Curvature of Antrum | 9 Participants |
Secondary
Number of Participants With Inflammation (Mononuclear Infiltration) in Greater Curvature of Middle Gastric Body
Numbers of participants with inflammation (mononuclear infiltration) in greater curvature of the middle gastric body for Vonoprazan group and Lansoprazole group at Week 268 (Week 260 in Maintenance Phase) were reported as histological assessment of gastritis.
Time frame: Up to Week 268 (Week 260 in Maintenance Phase)
Population: Safety Data Analysis Set in the Maintenance Phase: All participants who were enrolled in Maintenance Phase and who received at least one dose of any therapy in the Maintenance Phase of this study. The number analyzed is the number of participants with data available for analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Vonoprazan Group | Number of Participants With Inflammation (Mononuclear Infiltration) in Greater Curvature of Middle Gastric Body | 15 Participants |
| Lansoprazole Group | Number of Participants With Inflammation (Mononuclear Infiltration) in Greater Curvature of Middle Gastric Body | 9 Participants |
Secondary
Number of Participants With Intestinal Metaplasia in Greater Curvature of Antrum
Numbers of participants with intestinal metaplasia in greater curvature of the antrum for Vonoprazan group and Lansoprazole group at Week 268 (Week 260 in Maintenance Phase) were reported as histological assessment of gastritis.
Time frame: Up to Week 268 (Week 260 in Maintenance Phase)
Population: Safety Data Analysis Set in the Maintenance Phase: All participants who were enrolled in Maintenance Phase and who received at least one dose of any therapy in the Maintenance Phase of this study. The number analyzed is the number of participants with data available for analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Vonoprazan Group | Number of Participants With Intestinal Metaplasia in Greater Curvature of Antrum | 6 Participants |
| Lansoprazole Group | Number of Participants With Intestinal Metaplasia in Greater Curvature of Antrum | 6 Participants |
Secondary
Number of Participants With Intestinal Metaplasia in Greater Curvature of Middle Gastric Body
Numbers of participants with intestinal metaplasia in greater curvature of the middle gastric body for Vonoprazan group and Lansoprazole group at Week 268 (Week 260 in Maintenance Phase) were reported as histological assessment of gastritis.
Time frame: Up to Week 268 (Week 260 in Maintenance Phase)
Population: Safety Data Analysis Set in the Maintenance Phase: All participants who were enrolled in Maintenance Phase and who received at least one dose of any therapy in the Maintenance Phase of this study. The number analyzed is the number of participants with data available for analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Vonoprazan Group | Number of Participants With Intestinal Metaplasia in Greater Curvature of Middle Gastric Body | 0 Participants |
| Lansoprazole Group | Number of Participants With Intestinal Metaplasia in Greater Curvature of Middle Gastric Body | 0 Participants |
Secondary
Number of Participants With Multiple White and Flat Elevated Lesions
Numbers of participants with multiple white and flat elevated lesions for Vonoprazan group and Lansoprazole group at Week 268 (Week 260 in Maintenance Phase) were reported as the endpoint for endoscopic findings. The number analyzed is the number of participants with data available for analysis.
Time frame: Up to Week 268 (Week 260 in Maintenance Phase)
Population: Safety Data Analysis Set in the Maintenance Phase: All participants who were enrolled in Maintenance Phase and who received at least one dose of any therapy in the Maintenance Phase of this study. The number analyzed is the number of participants with data available for analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Vonoprazan Group | Number of Participants With Multiple White and Flat Elevated Lesions | 8 Participants |
| Lansoprazole Group | Number of Participants With Multiple White and Flat Elevated Lesions | 9 Participants |
Secondary
Number of Participants With Neutrophilic Infiltration in Greater Curvature of Antrum
Numbers of participants with neutrophilic infiltration in greater curvature of the antrum for Vonoprazan group and Lansoprazole group at Week 268 (Week 260 in Maintenance Phase) were reported as histological assessment of gastritis.
Time frame: Up to Week 268 (Week 260 in Maintenance Phase)
Population: Safety Data Analysis Set in the Maintenance Phase: All participants who were enrolled in Maintenance Phase and who received at least one dose of any therapy in the Maintenance Phase of this study. The number analyzed is the number of participants with data available for analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Vonoprazan Group | Number of Participants With Neutrophilic Infiltration in Greater Curvature of Antrum | 0 Participants |
| Lansoprazole Group | Number of Participants With Neutrophilic Infiltration in Greater Curvature of Antrum | 0 Participants |
Secondary
Number of Participants With Neutrophilic Infiltration in Greater Curvature of Middle Gastric Body
Numbers of participants with neutrophilic infiltration in greater curvature of the middle gastric body for Vonoprazan group and Lansoprazole group at Week 268 (Week 260 in Maintenance Phase) were reported as histological assessment of gastritis.
Time frame: Up to Week 268 (Week 260 in Maintenance Phase)
Population: Safety Data Analysis Set in the Maintenance Phase: All participants who were enrolled in Maintenance Phase and who received at least one dose of any therapy in the Maintenance Phase of this study. The number analyzed is the number of participants with data available for analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Vonoprazan Group | Number of Participants With Neutrophilic Infiltration in Greater Curvature of Middle Gastric Body | 1 Participants |
| Lansoprazole Group | Number of Participants With Neutrophilic Infiltration in Greater Curvature of Middle Gastric Body | 0 Participants |
Secondary
Number of Participants With Presence of H.Pylori in Greater Curvature of Antrum
Numbers of participants with presence of H.pylori in greater curvature of the antrum for Vonoprazan group and Lansoprazole group at Week 268 (Week 260 in Maintenance Phase) were reported as histological assessment of gastritis.
Time frame: Up to Week 268 (Week 260 in Maintenance Phase)
Population: Safety Data Analysis Set in the Maintenance Phase: All participants who were enrolled in Maintenance Phase and who received at least one dose of any therapy in the Maintenance Phase of this study. The number analyzed is the number of participants with data available for analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Vonoprazan Group | Number of Participants With Presence of H.Pylori in Greater Curvature of Antrum | 0 Participants |
| Lansoprazole Group | Number of Participants With Presence of H.Pylori in Greater Curvature of Antrum | 0 Participants |
Secondary
Number of Participants With Presence of H.Pylori in Greater Curvature of Middle Gastric Body
Numbers of participants with presence of H.pylori in greater curvature of the middle gastric body for Vonoprazan group and Lansoprazole group at Week 268 (Week 260 in Maintenance Phase) were reported as histological assessment of gastritis.
Time frame: Up to Week 268 (Week 260 in Maintenance Phase)
Population: Safety Data Analysis Set in the Maintenance Phase: All participants who were enrolled in Maintenance Phase and who received at least one dose of any therapy in the Maintenance Phase of this study. The number analyzed is the number of participants with data available for analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Vonoprazan Group | Number of Participants With Presence of H.Pylori in Greater Curvature of Middle Gastric Body | 0 Participants |
| Lansoprazole Group | Number of Participants With Presence of H.Pylori in Greater Curvature of Middle Gastric Body | 0 Participants |
Secondary
Percentage of Participants Who Healed EE at the End of Healing Phase
Percentage of participants who healed EE at the end of healing phase was reported.
Time frame: Up to Week 8
Population: Full Analysis Set in the Healing Phase: All participants who were randomized and who received at least one dose of any therapy in the Healing Phase of this study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vonoprazan Group | Percentage of Participants Who Healed EE at the End of Healing Phase | 1.4 Percentage of participants |
| Lansoprazole Group | Percentage of Participants Who Healed EE at the End of Healing Phase | 0.0 Percentage of participants |
Secondary
Percentage of Participants With Recurrence of Erosive Esophagitis (EE)
Erosive esophagitis recurrence is defined as endoscopically confirmed to have erosive esophagitis (LA classification grades O and A to D) during the Maintenance Phase. The LA classification graded as follows- Grade O: normal mucosa; Grade A: nonconfluent mucosal breaks \<5 mm in length; Grade B: nonconfluent mucosal breaks ≥ 5mm in length; Grade C: confluent mucosal breaks \<75% circumferential; Grade D: confluent mucosal breaks \>75% circumferential.
Time frame: Up to Week 268 (Week 260 in Maintenance Phase)
Population: Full Analysis Set in the Maintenance Phase: All participants who were randomized and who received at least one dose of any therapy in the Maintenance Phase of this study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vonoprazan Group | Percentage of Participants With Recurrence of Erosive Esophagitis (EE) | 3.8 Percentage of participants |
| Lansoprazole Group | Percentage of Participants With Recurrence of Erosive Esophagitis (EE) | 11.3 Percentage of participants |