Erosive Esophagitis
Conditions
Keywords
Drug therapy
Brief summary
This is a comparative study of vonoprazan (TAK-438) (10 mg or 20 mg) in participants in whom endoscopic healing of erosive esophagitis has been confirmed with vonoprazan or adequate treatment with a proton pump inhibitor (PPI), to demonstrate the non-inferiority of vonoprazan to lansoprazole in their maintenance treatment (6 months or 24 weeks) as well as to determine the clinically recommended dose for vonoprazan for maintenance therapy in erosive esophagitis.
Detailed description
The drug being tested in this study is called vonoprazan. Vonoprazan is being tested as a maintenance treatment for people with healed erosive esophagitis (EE). This study will look at participants in whom endoscopic healing of erosive esophagitis has been confirmed with vonoprazan or adequate treatment with a proton pump inhibitor (PPI), to demonstrate the non-inferiority of vonoprazan to Lansoprazole in their maintenance treatment (6 months or 24 weeks) as well as to determine the clinically recommended dose for vonoprazan for maintenance therapy in erosive esophagitis. The study will enroll approximately 693 patients. Participants will be randomly assigned (by chance, like flipping a coin) to one of the three treatment groups-which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need): * TAK-438 10 mg * TAK-438 20 mg * Lansoprazole 15 mg Participants with ongoing erosive esophagitis (EE) will receive lansoprazole 30 mg once daily for 4 or 8 weeks (the Healing phase) until healing of EE is confirmed by endoscopy performed at either Week -4 and/or Day 1 before eligible for randomization to maintenance phase. In Maintenance phase, participants with confirming EE healing will be asked to take 2 tablets and a capsule at the same time each morning after breakfast throughout the study. All participants will be asked to record daytime and nighttime (during sleep) subjective symptoms in a diary on a daily basis. This multi-centre trial will be conducted worldwide. The overall time to participate in this study is 8 months. Participants will make multiple visits to the clinic, and will be contacted by telephone 7-14 days after last dose of study drug for a follow-up assessment.
Interventions
DRUGVonoprazan
Vonoprazan tablets
DRUGLansoprazole
Lansoprazole capsules or tablets
Vonoprazan placebo-matching tablets
Lansoprazole placebo-matching capsules
Sponsors
Takeda
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements. 2. The participant or, when applicable, the participant's legally acceptable representative signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures. 3. Has been confirmed on endoscopy to have had erosive esophagitis \[Los Angeles (LA) classification grades A to D\] within 84 days of Day 1. 4. If the participant is not rolled over from TAK-438\_303 study, he/she has undergone an open-label Proton pump inhibitor (PPI) treatment (Lansoprazole 30 mg, once daily) of 4 or 8 weeks within the TAK-438\_305 protocol. 5. Has been confirmed on endoscopy to have healing of erosive esophagitis. This endoscopy, if not part of the TAK-438\_303 study, must have been within the last 14 days prior to randomization, otherwise the endoscopy must be repeated to confirm healing before randomization in the TAK-438\_305 study. 6. Is aged 18 years old or older (or the local age of consent if that is older), male or female, at the time of signing an informed consent, and is being treated on an outpatient basis for erosive esophagitis, including those temporarily admitted for examination. 7. A female participant of childbearing potential who is sexually active with a nonsterilized male partner agrees to use routinely adequate contraception from signing of informed consent throughout the duration of the study and for 4 weeks after last dose of study medication.
Exclusion criteria
1. Has received any investigational compound (other than study TAK-438\_303) within 84 days prior to screening phase. 2. Has received TAK-438 in a previous clinical study (other than study TAK-438\_303) or as a therapeutic agent. 3. Is an immediate family member, study site employee, or is in a dependent relationship with a study site employee who is involved in conduct of this study (eg, spouse, parent, child, sibling) or may consent under duress. 4. Has, in the judgment of the investigator, clinically significant abnormal hematological parameters of hemoglobin, hematocrit, or erythrocytes at Screening. 5. Has a history or clinical manifestations of significant central nervous system (CNS), cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, urological, endocrine or hematological disease. 6. Has a history of hypersensitivity or allergies to TAK-438 or to proton pump inhibitors (PPIs) including any associated excipients. 7. Has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse within 1 year prior to the start the screening phase. 8. Is required to take excluded medications. 9. If female, the participant is pregnant or lactating or intending to become pregnant before, during, or within 1 month after participating in this study; or intending to donate ova during such time period. 10. Has participated in another clinical study (other than study TAK-438\_303) within the past 30 days from Visit 1. 11. Has co-morbidities that could affect the esophagus (eosinophilic esophagitis, esophageal varices, scleroderma, viral or fungal infection, esophageal strictures), a history of radiotherapy or cryotherapy for the esophagus; those with corrosive or physiochemical injury (with the possible inclusion in the study of those with Schatzki's ring or Barrett's esophagus). 12. Has a history of surgical procedures that may affect the esophagus (eg, fundoplication and mechanical dilatation for esophageal strictures excluding Schatzki's ring) or a history of gastric or duodenal surgery excluding endoscopic removal of benign polyps. 13. Developed acute upper gastrointestinal bleeding, gastric ulcer (a mucosal defect with white coating) or duodenal ulcer (a mucosal defect with white coating), within 30 days before the start of the Screening Phase (Visit 1) (with the possible inclusion of those with gastric or duodenal erosion). Participants requiring non-steroidal anti-inflammatory drugs (NSAIDs) or aspirin treatment along with the concomitant PPI therapy to prevent gastrointestinal (GI) bleeding should not be enrolled. 14. Has Zollinger-Ellison syndrome or gastric acid hypersecretion or a history of gastric acid hypersecretion. 15. Is scheduled for surgery that requires hospitalization or requires surgical treatment during his/her participation in the study. 16. Has a history of malignancy or was treated for malignancy within 5 years before the start of the Screening Phase (visit 1) (the participant may be included in the study if he/she has cured cutaneous basal cell carcinoma or cervical carcinoma in situ). 17. Has acquired immunodeficiency syndrome (AIDS) or hepatitis, including hepatitis virus carriers (hepatitis B surface antigen \[HBsAg\] or hepatitis C virus (HCV)-antibody-positive) (the participant may be included in the study if he/she is HCV-antigen or HCV-ribonucleic acid \[RNA\]-negative). 18. Laboratory tests performed on visit 1 revealed any of the following abnormalities in the participant: 1. Creatinine levels: \>2 mg/dL (\>177 μmol/L). 2. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST), or total bilirubin levels: \> upper limit of normal (ULN).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Recurrence of Erosive Esophagitis as Confirmed on Endoscopy After the 24-week Maintenance Phase | 24 weeks | Erosive esophagitis recurrence is defined as participants endoscopically confirmed to have erosive esophagitis (Los Angeles \[LA\] classification grades A to D) during the Maintenance Phase (24 weeks). Grade A: \>/=1 mucosal breaks \</=5 mm, none of which extends between the tops of the mucosal folds; Grade B: \>/=1 mucosal breaks \>5 mm, none of which extends between the tops of two mucosal folds; Grade C: mucosal breaks that extend between the tops of two or more mucosal folds, but which involve \<75% of esophageal circumference; Grade D: mucosal breaks which involve \>/=75% of esophageal circumference. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events (AEs) | From Day 1 to 14 days after the last dose of study medication (up to 26 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. |
| Number of Participants With Abnormal Clinical Laboratory Findings | From Day 1 to 14 days after the last dose of study medication (up to 26 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. |
| Number of Participants With Abnormal Electrocardiogram (ECG) Findings | From Day 1 to 14 days after the last dose of study medication (up to 26 weeks) | Number of participants with any markedly abnormal 12-lead ECG findings is reported. bpm = beats per minute, msec = milliseconds, CHG= change from baseline. |
| Percentage of Participants With Recurrence of Erosive Esophagitis After 12 Weeks of Treatment in the Maintenance Phase | 12 weeks | Erosive esophagitis recurrence is defined as endoscopically confirmed to have erosive esophagitis (LA classification grades A to D) during the Maintenance Phase (12 weeks). Grade A: \>/=1 mucosal breaks \</=5 mm, none of which extends between the tops of the mucosal folds; Grade B: \>/=1 mucosal breaks \>5 mm, none of which extends between the tops of two mucosal folds; Grade C: mucosal breaks that extend between the tops of two or more mucosal folds, but which involve \<75% of esophageal circumference; Grade D: mucosal breaks which involve \>/=75% of esophageal circumference. |
| Change From Baseline in Serum Gastrin | Baseline and Weeks 4, 12 and 24 | — |
| Change From Baseline in Serum Pepsinogen I | Baseline and Weeks 4, 12 and 24 | — |
| Change From Baseline in Serum Pepsinogen II | Baseline and Weeks 4, 12 and 24 | — |
| Number of Participants With Abnormal Vital Sign Measurements | From Day 1 to 14 days after the last dose of study medication (up to 26 weeks) | The percentage of participants with any markedly abnormal vital sign measurements including (body temperature, blood pressure and pulse), mmHg = millimeters of mercury. |
Countries
China, Malaysia, South Korea, Taiwan
Participant flow
Recruitment details
Participants took part in the study at 64 investigative sites in China, Malaysia, South Korea, and Taiwan from 01 April 2015 to 31 December 2018.
Pre-assignment details
Participants with a diagnosis of erosive esophagitis were enrolled to receive lansoprazole 30 mg for 4 or 8 weeks (Healing Phase); or vonoprazan 10 mg, 20 mg; or lansoprazole 15 mg once daily for up to 24 weeks (Maintenance Phase).
Participants by arm
| Arm | Count |
|---|---|
| Vonoprazan 10 mg Lansoprazole 30 mg, capsules or tablets, orally, once, daily, for up to 4 or 8 weeks or until confirmed healing of erosive esophagitis (EE) in healing phase for participants with ongoing EE. Vonoprazan 10 mg, tablets, orally, once, daily, and Vonoprazan 20 mg, placebo-matching tablets, orally, once, daily, and Lansoprazole 15 mg placebo-matching, capsules, orally, once, daily, for up to 24 weeks in maintenance phase for participants with confirmed EE healing. | 235 |
| Vonoprazan 20 mg Lansoprazole 30 mg, capsules or tablets, orally, once, daily, for up to 4 or 8 weeks or until confirmed healing of erosive esophagitis (EE) in healing phase for participants with ongoing EE. Vonoprazan 20 mg, tablets, orally, once, daily, and Vonoprazan 10 mg, placebo-matching tablets, orally, once, daily, and Lansoprazole 15 mg, placebo-matching capsules, orally, once, daily, for up to 24 weeks in maintenance phase for participants with confirmed EE healing. | 226 |
| Lansoprazole 15 mg Lansoprazole 30 mg, capsules or tablets, orally, once, daily, for up to 4 or 8 weeks or until confirmed healing of erosive esophagitis (EE) in healing phase for participants with ongoing EE. Lansoprazole 15 mg, capsules, orally, once, daily, and Vonoprazan 10 mg, placebo-matching tablets, orally, once, daily, and Vonoprazan 20 mg, placebo-matching tablets, orally, once, daily, for up to 24 weeks in maintenance phase for participants with confirmed EE healing. | 242 |
| Total | 703 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lack of Efficacy | 3 | 0 | 3 |
| Overall Study | Lost to Follow-up | 5 | 1 | 4 |
| Overall Study | Major Protocol Deviation | 18 | 25 | 22 |
| Overall Study | Pretreatment Event/Adverse Event | 13 | 11 | 12 |
| Overall Study | Reason Not Specified | 5 | 5 | 4 |
| Overall Study | Voluntary Withdrawal | 10 | 18 | 17 |
Baseline characteristics
| Characteristic | Vonoprazan 10 mg | Vonoprazan 20 mg | Lansoprazole 15 mg | Total |
|---|---|---|---|---|
| Age, Continuous | 51.7 years STANDARD_DEVIATION 11.79 | 52.8 years STANDARD_DEVIATION 13.02 | 54.0 years STANDARD_DEVIATION 12.8 | 52.8 years STANDARD_DEVIATION 12.56 |
| Barrett's Mucosa (Baseline) Absent | 212 Participants | 197 Participants | 218 Participants | 627 Participants |
| Barrett's Mucosa (Baseline) Present (3 cm or Greater) | 3 Participants | 0 Participants | 3 Participants | 6 Participants |
| Barrett's Mucosa (Baseline) Present (Less than 3 cm) | 16 Participants | 24 Participants | 16 Participants | 56 Participants |
| Barrett's Mucosa (Baseline) Unknown | 4 Participants | 5 Participants | 4 Participants | 13 Participants |
| Body Mass Index (BMI) | 25.10 kg/m^2 STANDARD_DEVIATION 3.449 | 24.58 kg/m^2 STANDARD_DEVIATION 3.052 | 24.77 kg/m^2 STANDARD_DEVIATION 3.475 | 24.82 kg/m^2 STANDARD_DEVIATION 3.338 |
| Consumption of Alcohol Drink a Couple of Days Per Month | 53 Participants | 48 Participants | 41 Participants | 142 Participants |
| Consumption of Alcohol Drink a Couple of Days Per Week | 28 Participants | 19 Participants | 29 Participants | 76 Participants |
| Consumption of Alcohol Drink Everyday | 11 Participants | 12 Participants | 16 Participants | 39 Participants |
| Consumption of Alcohol Never Drink | 143 Participants | 147 Participants | 156 Participants | 446 Participants |
| Consumption of Caffeine No | 198 Participants | 192 Participants | 199 Participants | 589 Participants |
| Consumption of Caffeine Yes | 37 Participants | 34 Participants | 43 Participants | 114 Participants |
| EQ VAS Score (Baseline) | 88.2 score on scale STANDARD_DEVIATION 11.1 | 89.3 score on scale STANDARD_DEVIATION 8.85 | 89.4 score on scale STANDARD_DEVIATION 9.03 | 89.0 score on scale STANDARD_DEVIATION 9.71 |
| Esophageal Hiatal Hernia (Baseline) Absent | 174 Participants | 179 Participants | 184 Participants | 537 Participants |
| Esophageal Hiatal Hernia (Baseline) Present (2 cm or Greater) | 27 Participants | 22 Participants | 23 Participants | 72 Participants |
| Esophageal Hiatal Hernia (Baseline) Present (Less than 2 cm) | 30 Participants | 22 Participants | 29 Participants | 81 Participants |
| Esophageal Hiatal Hernia (Baseline) Unknown | 4 Participants | 3 Participants | 5 Participants | 12 Participants |
| Height | 166.7 centimeter (cm) STANDARD_DEVIATION 8.35 | 166.1 centimeter (cm) STANDARD_DEVIATION 8.31 | 167.1 centimeter (cm) STANDARD_DEVIATION 8.01 | 166.7 centimeter (cm) STANDARD_DEVIATION 8.22 |
| History of H.pylori Eradication Therapy No | 209 Participants | 198 Participants | 215 Participants | 622 Participants |
| History of H.pylori Eradication Therapy Yes (End of Treatment: More than 1 Year) | 20 Participants | 19 Participants | 16 Participants | 55 Participants |
| History of H.pylori Eradication Therapy Yes (End of Treatment: Within Past 1 Year) | 6 Participants | 9 Participants | 11 Participants | 26 Participants |
| HRQoL (EQ-5D-5L) | 0.9723 score on scale STANDARD_DEVIATION 0.0461 | 0.9723 score on scale STANDARD_DEVIATION 0.05252 | 0.9696 score on scale STANDARD_DEVIATION 0.06227 | 0.9713 score on scale STANDARD_DEVIATION 0.0541 |
| LA Classification (Time of Diagnosis) Grade A | 91 Participants | 96 Participants | 93 Participants | 280 Participants |
| LA Classification (Time of Diagnosis) Grade A/B | 185 Participants | 180 Participants | 193 Participants | 558 Participants |
| LA Classification (Time of Diagnosis) Grade B | 94 Participants | 84 Participants | 100 Participants | 278 Participants |
| LA Classification (Time of Diagnosis) Grade C | 42 Participants | 39 Participants | 38 Participants | 119 Participants |
| LA Classification (Time of Diagnosis) Grade C/D | 50 Participants | 46 Participants | 49 Participants | 145 Participants |
| LA Classification (Time of Diagnosis) Grade D | 8 Participants | 7 Participants | 11 Participants | 26 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 235 Participants | 225 Participants | 242 Participants | 702 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment China | 163 Participants | 159 Participants | 169 Participants | 491 Participants |
| Region of Enrollment Korea, Republic Of | 26 Participants | 23 Participants | 27 Participants | 76 Participants |
| Region of Enrollment Malaysia | 24 Participants | 24 Participants | 24 Participants | 72 Participants |
| Region of Enrollment Taiwan, Province Of China | 22 Participants | 20 Participants | 22 Participants | 64 Participants |
| Sex: Female, Male Female | 59 Participants | 61 Participants | 64 Participants | 184 Participants |
| Sex: Female, Male Male | 176 Participants | 165 Participants | 178 Participants | 519 Participants |
| Smoking Classification The Participant Has Never Smoked | 157 Participants | 135 Participants | 147 Participants | 439 Participants |
| Smoking Classification The Participant Is a Current Smoker | 50 Participants | 47 Participants | 55 Participants | 152 Participants |
| Smoking Classification The Participant Is an Ex-smoker | 28 Participants | 44 Participants | 40 Participants | 112 Participants |
| Weight | 70.03 kilogram (kg) STANDARD_DEVIATION 12.137 | 68.10 kilogram (kg) STANDARD_DEVIATION 11.314 | 69.19 kilogram (kg) STANDARD_DEVIATION 11.075 | 69.12 kilogram (kg) STANDARD_DEVIATION 11.528 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 235 | 0 / 226 | 1 / 242 |
| other Total, other adverse events | 81 / 235 | 79 / 226 | 79 / 242 |
| serious Total, serious adverse events | 10 / 235 | 8 / 226 | 12 / 242 |
Outcome results
Primary
Percentage of Participants With Recurrence of Erosive Esophagitis as Confirmed on Endoscopy After the 24-week Maintenance Phase
Erosive esophagitis recurrence is defined as participants endoscopically confirmed to have erosive esophagitis (Los Angeles \[LA\] classification grades A to D) during the Maintenance Phase (24 weeks). Grade A: \>/=1 mucosal breaks \</=5 mm, none of which extends between the tops of the mucosal folds; Grade B: \>/=1 mucosal breaks \>5 mm, none of which extends between the tops of two mucosal folds; Grade C: mucosal breaks that extend between the tops of two or more mucosal folds, but which involve \<75% of esophageal circumference; Grade D: mucosal breaks which involve \>/=75% of esophageal circumference.
Time frame: 24 weeks
Population: Full analysis set included all randomized participants who received at least 1 dose of the Maintenance Phase drug and had at least 1 post-baseline endoscopy, and was based on randomized treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vonoprazan 10 mg | Percentage of Participants With Recurrence of Erosive Esophagitis as Confirmed on Endoscopy After the 24-week Maintenance Phase | 13.3 percentage of participants |
| Vonoprazan 20 mg | Percentage of Participants With Recurrence of Erosive Esophagitis as Confirmed on Endoscopy After the 24-week Maintenance Phase | 12.3 percentage of participants |
| Lansoprazole 15 mg | Percentage of Participants With Recurrence of Erosive Esophagitis as Confirmed on Endoscopy After the 24-week Maintenance Phase | 25.5 percentage of participants |
Secondary
Change From Baseline in Serum Gastrin
Time frame: Baseline and Weeks 4, 12 and 24
Population: Safety analysis set included all participants who took at least 1 dose of the Maintenance Phase drug and was based on the treatment received in the Maintenance Phase. The number analyzed is the number of participants with data available for analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vonoprazan 10 mg | Change From Baseline in Serum Gastrin | Baseline | 20.42 pmol/L | Standard Deviation 33.969 |
| Vonoprazan 10 mg | Change From Baseline in Serum Gastrin | Change at Week 4 | 10.09 pmol/L | Standard Deviation 37.747 |
| Vonoprazan 10 mg | Change From Baseline in Serum Gastrin | Change at Week 12 | 14.45 pmol/L | Standard Deviation 29.439 |
| Vonoprazan 10 mg | Change From Baseline in Serum Gastrin | Change at Week 24 | 17.47 pmol/L | Standard Deviation 39.847 |
| Vonoprazan 20 mg | Change From Baseline in Serum Gastrin | Change at Week 24 | 37.60 pmol/L | Standard Deviation 47.172 |
| Vonoprazan 20 mg | Change From Baseline in Serum Gastrin | Baseline | 17.97 pmol/L | Standard Deviation 21.458 |
| Vonoprazan 20 mg | Change From Baseline in Serum Gastrin | Change at Week 12 | 31.92 pmol/L | Standard Deviation 45.127 |
| Vonoprazan 20 mg | Change From Baseline in Serum Gastrin | Change at Week 4 | 22.76 pmol/L | Standard Deviation 36.053 |
| Lansoprazole 15 mg | Change From Baseline in Serum Gastrin | Change at Week 24 | -7.41 pmol/L | Standard Deviation 22.21 |
| Lansoprazole 15 mg | Change From Baseline in Serum Gastrin | Change at Week 4 | -11.21 pmol/L | Standard Deviation 24.651 |
| Lansoprazole 15 mg | Change From Baseline in Serum Gastrin | Change at Week 12 | -8.76 pmol/L | Standard Deviation 24.578 |
| Lansoprazole 15 mg | Change From Baseline in Serum Gastrin | Baseline | 21.94 pmol/L | Standard Deviation 27.905 |
Secondary
Change From Baseline in Serum Pepsinogen I
Time frame: Baseline and Weeks 4, 12 and 24
Population: Safety analysis set included all participants who took at least 1 dose of the Maintenance Phase drug and was based on the treatment received in the Maintenance Phase. The number analyzed is the number of participants with data available for analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vonoprazan 10 mg | Change From Baseline in Serum Pepsinogen I | Change at Week 12 | -3.1 ug/L | Standard Deviation 267.65 |
| Vonoprazan 10 mg | Change From Baseline in Serum Pepsinogen I | Baseline | 287.1 ug/L | Standard Deviation 249.41 |
| Vonoprazan 10 mg | Change From Baseline in Serum Pepsinogen I | Change at Week 24 | 5.9 ug/L | Standard Deviation 289.91 |
| Vonoprazan 10 mg | Change From Baseline in Serum Pepsinogen I | Change at Week 4 | 40.5 ug/L | Standard Deviation 266.92 |
| Vonoprazan 20 mg | Change From Baseline in Serum Pepsinogen I | Change at Week 12 | 89.9 ug/L | Standard Deviation 285.05 |
| Vonoprazan 20 mg | Change From Baseline in Serum Pepsinogen I | Change at Week 4 | 139.8 ug/L | Standard Deviation 269.08 |
| Vonoprazan 20 mg | Change From Baseline in Serum Pepsinogen I | Baseline | 276.3 ug/L | Standard Deviation 203.46 |
| Vonoprazan 20 mg | Change From Baseline in Serum Pepsinogen I | Change at Week 24 | 55.4 ug/L | Standard Deviation 279.65 |
| Lansoprazole 15 mg | Change From Baseline in Serum Pepsinogen I | Change at Week 4 | -112.3 ug/L | Standard Deviation 245.22 |
| Lansoprazole 15 mg | Change From Baseline in Serum Pepsinogen I | Baseline | 303.3 ug/L | Standard Deviation 253.76 |
| Lansoprazole 15 mg | Change From Baseline in Serum Pepsinogen I | Change at Week 24 | -103.9 ug/L | Standard Deviation 218.8 |
| Lansoprazole 15 mg | Change From Baseline in Serum Pepsinogen I | Change at Week 12 | -123.5 ug/L | Standard Deviation 252.45 |
Secondary
Change From Baseline in Serum Pepsinogen II
Time frame: Baseline and Weeks 4, 12 and 24
Population: Safety analysis set included all participants who took at least 1 dose of the Maintenance Phase drug and was based on the treatment received in the Maintenance Phase.The number analyzed is the number of participants with data available for analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vonoprazan 10 mg | Change From Baseline in Serum Pepsinogen II | Baseline | 22.9 ug/L | Standard Deviation 22.42 |
| Vonoprazan 10 mg | Change From Baseline in Serum Pepsinogen II | Change at Week 4 | 3.8 ug/L | Standard Deviation 27.34 |
| Vonoprazan 10 mg | Change From Baseline in Serum Pepsinogen II | Change at Week 12 | -1.6 ug/L | Standard Deviation 24.02 |
| Vonoprazan 10 mg | Change From Baseline in Serum Pepsinogen II | Change at Week 24 | -0.6 ug/L | Standard Deviation 27.23 |
| Vonoprazan 20 mg | Change From Baseline in Serum Pepsinogen II | Change at Week 24 | 5.8 ug/L | Standard Deviation 25.59 |
| Vonoprazan 20 mg | Change From Baseline in Serum Pepsinogen II | Baseline | 22.1 ug/L | Standard Deviation 17.4 |
| Vonoprazan 20 mg | Change From Baseline in Serum Pepsinogen II | Change at Week 12 | 9.0 ug/L | Standard Deviation 26.4 |
| Vonoprazan 20 mg | Change From Baseline in Serum Pepsinogen II | Change at Week 4 | 16.5 ug/L | Standard Deviation 25.56 |
| Lansoprazole 15 mg | Change From Baseline in Serum Pepsinogen II | Change at Week 24 | -8.7 ug/L | Standard Deviation 19.61 |
| Lansoprazole 15 mg | Change From Baseline in Serum Pepsinogen II | Change at Week 4 | -10.9 ug/L | Standard Deviation 23.98 |
| Lansoprazole 15 mg | Change From Baseline in Serum Pepsinogen II | Change at Week 12 | -10.9 ug/L | Standard Deviation 24.41 |
| Lansoprazole 15 mg | Change From Baseline in Serum Pepsinogen II | Baseline | 24.6 ug/L | Standard Deviation 23.83 |
Secondary
Number of Participants With Abnormal Clinical Laboratory Findings
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.
Time frame: From Day 1 to 14 days after the last dose of study medication (up to 26 weeks)
Population: Safety analysis set included all participants who took at least 1 dose of the Maintenance Phase drug and was based on the treatment received in the Maintenance Phase. The number analyzed is the number of participants with data available for analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vonoprazan 10 mg | Number of Participants With Abnormal Clinical Laboratory Findings | Hematology: White Blood Cells (>1.5xULN) | 0 Participants |
| Vonoprazan 10 mg | Number of Participants With Abnormal Clinical Laboratory Findings | Serum Chemistry: Creatinine (>177 umol/L) | 0 Participants |
| Vonoprazan 10 mg | Number of Participants With Abnormal Clinical Laboratory Findings | Hematology: Lymphocytes (>1.5xULN) | 1 Participants |
| Vonoprazan 10 mg | Number of Participants With Abnormal Clinical Laboratory Findings | Serum Chemistry: Glucose (>19.4 mmol/L) | 1 Participants |
| Vonoprazan 10 mg | Number of Participants With Abnormal Clinical Laboratory Findings | Serum Chemistry: Albumin (<25 g/L) | 0 Participants |
| Vonoprazan 10 mg | Number of Participants With Abnormal Clinical Laboratory Findings | Serum Chemistry: ALT (>3xULN) | 1 Participants |
| Vonoprazan 10 mg | Number of Participants With Abnormal Clinical Laboratory Findings | Serum Chemistry: Glucose (<2.8 mmol/L) | 1 Participants |
| Vonoprazan 10 mg | Number of Participants With Abnormal Clinical Laboratory Findings | Serum Chemistry: CK (CPK) (>5xULN) | 4 Participants |
| Vonoprazan 10 mg | Number of Participants With Abnormal Clinical Laboratory Findings | Serum Chemistry: AST (>3xULN) | 2 Participants |
| Vonoprazan 10 mg | Number of Participants With Abnormal Clinical Laboratory Findings | Hematology: Hemoglobin (<0.8xLLN) | 1 Participants |
| Vonoprazan 10 mg | Number of Participants With Abnormal Clinical Laboratory Findings | Serum Chemistry: GGT (>3xULN) | 4 Participants |
| Vonoprazan 10 mg | Number of Participants With Abnormal Clinical Laboratory Findings | Serum Chemistry: Potassium (<3.0 mmol/L) | 0 Participants |
| Vonoprazan 10 mg | Number of Participants With Abnormal Clinical Laboratory Findings | Serum Chemistry: Triglycerides (>2.5xULN) | 2 Participants |
| Vonoprazan 10 mg | Number of Participants With Abnormal Clinical Laboratory Findings | Hematology: Hematocrit (<0.8xLLN) | 0 Participants |
| Vonoprazan 10 mg | Number of Participants With Abnormal Clinical Laboratory Findings | Hematology: Red Blood Cells (>1.2xULN) | 1 Participants |
| Vonoprazan 10 mg | Number of Participants With Abnormal Clinical Laboratory Findings | Serum Chemistry: Total Cholesterol (>7.72 mmol/L) | 2 Participants |
| Vonoprazan 10 mg | Number of Participants With Abnormal Clinical Laboratory Findings | Hematology: Platelets (<75x10^9/L) | 0 Participants |
| Vonoprazan 10 mg | Number of Participants With Abnormal Clinical Laboratory Findings | Serum Chemistry: Vitamin B12 (<92 pmol/L) | 1 Participants |
| Vonoprazan 10 mg | Number of Participants With Abnormal Clinical Laboratory Findings | Serum Chemistry: Uric Acid (>0.773 mmol/L) | 0 Participants |
| Vonoprazan 10 mg | Number of Participants With Abnormal Clinical Laboratory Findings | Hematology: Neutrophils (<0.5xLLN) | 1 Participants |
| Vonoprazan 10 mg | Number of Participants With Abnormal Clinical Laboratory Findings | Serum Chemistry: Sodium (>150 mmol/L) | 1 Participants |
| Vonoprazan 10 mg | Number of Participants With Abnormal Clinical Laboratory Findings | Serum Chemistry: BUN (>10.7 mmol/L) | 2 Participants |
| Vonoprazan 10 mg | Number of Participants With Abnormal Clinical Laboratory Findings | Hematology: Eosinophils (>2xULN) | 2 Participants |
| Vonoprazan 20 mg | Number of Participants With Abnormal Clinical Laboratory Findings | Hematology: White Blood Cells (>1.5xULN) | 0 Participants |
| Vonoprazan 20 mg | Number of Participants With Abnormal Clinical Laboratory Findings | Serum Chemistry: Glucose (<2.8 mmol/L) | 0 Participants |
| Vonoprazan 20 mg | Number of Participants With Abnormal Clinical Laboratory Findings | Hematology: Red Blood Cells (>1.2xULN) | 0 Participants |
| Vonoprazan 20 mg | Number of Participants With Abnormal Clinical Laboratory Findings | Hematology: Hemoglobin (<0.8xLLN) | 1 Participants |
| Vonoprazan 20 mg | Number of Participants With Abnormal Clinical Laboratory Findings | Hematology: Hematocrit (<0.8xLLN) | 1 Participants |
| Vonoprazan 20 mg | Number of Participants With Abnormal Clinical Laboratory Findings | Hematology: Platelets (<75x10^9/L) | 1 Participants |
| Vonoprazan 20 mg | Number of Participants With Abnormal Clinical Laboratory Findings | Hematology: Neutrophils (<0.5xLLN) | 0 Participants |
| Vonoprazan 20 mg | Number of Participants With Abnormal Clinical Laboratory Findings | Hematology: Eosinophils (>2xULN) | 2 Participants |
| Vonoprazan 20 mg | Number of Participants With Abnormal Clinical Laboratory Findings | Hematology: Lymphocytes (>1.5xULN) | 0 Participants |
| Vonoprazan 20 mg | Number of Participants With Abnormal Clinical Laboratory Findings | Serum Chemistry: ALT (>3xULN) | 1 Participants |
| Vonoprazan 20 mg | Number of Participants With Abnormal Clinical Laboratory Findings | Serum Chemistry: AST (>3xULN) | 0 Participants |
| Vonoprazan 20 mg | Number of Participants With Abnormal Clinical Laboratory Findings | Serum Chemistry: GGT (>3xULN) | 2 Participants |
| Vonoprazan 20 mg | Number of Participants With Abnormal Clinical Laboratory Findings | Serum Chemistry: CK (CPK) (>5xULN) | 2 Participants |
| Vonoprazan 20 mg | Number of Participants With Abnormal Clinical Laboratory Findings | Serum Chemistry: Albumin (<25 g/L) | 0 Participants |
| Vonoprazan 20 mg | Number of Participants With Abnormal Clinical Laboratory Findings | Serum Chemistry: Creatinine (>177 umol/L) | 0 Participants |
| Vonoprazan 20 mg | Number of Participants With Abnormal Clinical Laboratory Findings | Serum Chemistry: BUN (>10.7 mmol/L) | 4 Participants |
| Vonoprazan 20 mg | Number of Participants With Abnormal Clinical Laboratory Findings | Serum Chemistry: Uric Acid (>0.773 mmol/L) | 1 Participants |
| Vonoprazan 20 mg | Number of Participants With Abnormal Clinical Laboratory Findings | Serum Chemistry: Total Cholesterol (>7.72 mmol/L) | 5 Participants |
| Vonoprazan 20 mg | Number of Participants With Abnormal Clinical Laboratory Findings | Serum Chemistry: Triglycerides (>2.5xULN) | 5 Participants |
| Vonoprazan 20 mg | Number of Participants With Abnormal Clinical Laboratory Findings | Serum Chemistry: Glucose (>19.4 mmol/L) | 0 Participants |
| Vonoprazan 20 mg | Number of Participants With Abnormal Clinical Laboratory Findings | Serum Chemistry: Potassium (<3.0 mmol/L) | 0 Participants |
| Vonoprazan 20 mg | Number of Participants With Abnormal Clinical Laboratory Findings | Serum Chemistry: Sodium (>150 mmol/L) | 0 Participants |
| Vonoprazan 20 mg | Number of Participants With Abnormal Clinical Laboratory Findings | Serum Chemistry: Vitamin B12 (<92 pmol/L) | 0 Participants |
| Lansoprazole 15 mg | Number of Participants With Abnormal Clinical Laboratory Findings | Serum Chemistry: BUN (>10.7 mmol/L) | 2 Participants |
| Lansoprazole 15 mg | Number of Participants With Abnormal Clinical Laboratory Findings | Hematology: Platelets (<75x10^9/L) | 0 Participants |
| Lansoprazole 15 mg | Number of Participants With Abnormal Clinical Laboratory Findings | Serum Chemistry: Potassium (<3.0 mmol/L) | 1 Participants |
| Lansoprazole 15 mg | Number of Participants With Abnormal Clinical Laboratory Findings | Serum Chemistry: Uric Acid (>0.773 mmol/L) | 0 Participants |
| Lansoprazole 15 mg | Number of Participants With Abnormal Clinical Laboratory Findings | Hematology: Hematocrit (<0.8xLLN) | 1 Participants |
| Lansoprazole 15 mg | Number of Participants With Abnormal Clinical Laboratory Findings | Hematology: Red Blood Cells (>1.2xULN) | 1 Participants |
| Lansoprazole 15 mg | Number of Participants With Abnormal Clinical Laboratory Findings | Serum Chemistry: Total Cholesterol (>7.72 mmol/L) | 3 Participants |
| Lansoprazole 15 mg | Number of Participants With Abnormal Clinical Laboratory Findings | Hematology: Hemoglobin (<0.8xLLN) | 1 Participants |
| Lansoprazole 15 mg | Number of Participants With Abnormal Clinical Laboratory Findings | Serum Chemistry: Vitamin B12 (<92 pmol/L) | 3 Participants |
| Lansoprazole 15 mg | Number of Participants With Abnormal Clinical Laboratory Findings | Serum Chemistry: Triglycerides (>2.5xULN) | 6 Participants |
| Lansoprazole 15 mg | Number of Participants With Abnormal Clinical Laboratory Findings | Hematology: White Blood Cells (>1.5xULN) | 1 Participants |
| Lansoprazole 15 mg | Number of Participants With Abnormal Clinical Laboratory Findings | Serum Chemistry: AST (>3xULN) | 2 Participants |
| Lansoprazole 15 mg | Number of Participants With Abnormal Clinical Laboratory Findings | Serum Chemistry: Glucose (<2.8 mmol/L) | 1 Participants |
| Lansoprazole 15 mg | Number of Participants With Abnormal Clinical Laboratory Findings | Serum Chemistry: ALT (>3xULN) | 0 Participants |
| Lansoprazole 15 mg | Number of Participants With Abnormal Clinical Laboratory Findings | Serum Chemistry: GGT (>3xULN) | 7 Participants |
| Lansoprazole 15 mg | Number of Participants With Abnormal Clinical Laboratory Findings | Hematology: Lymphocytes (>1.5xULN) | 0 Participants |
| Lansoprazole 15 mg | Number of Participants With Abnormal Clinical Laboratory Findings | Serum Chemistry: Sodium (>150 mmol/L) | 0 Participants |
| Lansoprazole 15 mg | Number of Participants With Abnormal Clinical Laboratory Findings | Serum Chemistry: Albumin (<25 g/L) | 1 Participants |
| Lansoprazole 15 mg | Number of Participants With Abnormal Clinical Laboratory Findings | Hematology: Eosinophils (>2xULN) | 0 Participants |
| Lansoprazole 15 mg | Number of Participants With Abnormal Clinical Laboratory Findings | Serum Chemistry: Glucose (>19.4 mmol/L) | 0 Participants |
| Lansoprazole 15 mg | Number of Participants With Abnormal Clinical Laboratory Findings | Serum Chemistry: Creatinine (>177 umol/L) | 1 Participants |
| Lansoprazole 15 mg | Number of Participants With Abnormal Clinical Laboratory Findings | Hematology: Neutrophils (<0.5xLLN) | 0 Participants |
| Lansoprazole 15 mg | Number of Participants With Abnormal Clinical Laboratory Findings | Serum Chemistry: CK (CPK) (>5xULN) | 3 Participants |
Secondary
Number of Participants With Abnormal Electrocardiogram (ECG) Findings
Number of participants with any markedly abnormal 12-lead ECG findings is reported. bpm = beats per minute, msec = milliseconds, CHG= change from baseline.
Time frame: From Day 1 to 14 days after the last dose of study medication (up to 26 weeks)
Population: Safety analysis set included all participants who took at least 1 dose of the Maintenance Phase drug and was based on the treatment received in the Maintenance Phase. The number analyzed is the number of participants with data available for analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vonoprazan 10 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Heart Rate (<50 bpm) | 8 Participants |
| Vonoprazan 10 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Heart Rate (>120 bpm) | 0 Participants |
| Vonoprazan 10 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | QT Interval (>=460 msec) | 9 Participants |
| Vonoprazan 10 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | QTcF Interval (>= 500, or >= 450 with CHG >= 30) | 8 Participants |
| Vonoprazan 20 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | QTcF Interval (>= 500, or >= 450 with CHG >= 30) | 3 Participants |
| Vonoprazan 20 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Heart Rate (<50 bpm) | 7 Participants |
| Vonoprazan 20 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | QT Interval (>=460 msec) | 5 Participants |
| Vonoprazan 20 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Heart Rate (>120 bpm) | 1 Participants |
| Lansoprazole 15 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | QTcF Interval (>= 500, or >= 450 with CHG >= 30) | 6 Participants |
| Lansoprazole 15 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Heart Rate (>120 bpm) | 0 Participants |
| Lansoprazole 15 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | QT Interval (>=460 msec) | 8 Participants |
| Lansoprazole 15 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Heart Rate (<50 bpm) | 4 Participants |
Secondary
Number of Participants With Abnormal Vital Sign Measurements
The percentage of participants with any markedly abnormal vital sign measurements including (body temperature, blood pressure and pulse), mmHg = millimeters of mercury.
Time frame: From Day 1 to 14 days after the last dose of study medication (up to 26 weeks)
Population: Safety analysis set included all participants who took at least 1 dose of the Maintenance Phase drug and was based on the treatment received in the Maintenance Phase. The number analyzed is the number of participants with data available for analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vonoprazan 10 mg | Number of Participants With Abnormal Vital Sign Measurements | Systolic Blood Pressure (<85 mmHg) | 2 Participants |
| Vonoprazan 10 mg | Number of Participants With Abnormal Vital Sign Measurements | Pulse (>120 bpm) | 1 Participants |
| Vonoprazan 10 mg | Number of Participants With Abnormal Vital Sign Measurements | Diastolic Blood Pressure (>110 mmHg) | 1 Participants |
| Vonoprazan 10 mg | Number of Participants With Abnormal Vital Sign Measurements | Diastolic Blood Pressure (<50 mmHg) | 0 Participants |
| Vonoprazan 10 mg | Number of Participants With Abnormal Vital Sign Measurements | Body Temperature (>37.7 °Celsius) | 0 Participants |
| Vonoprazan 10 mg | Number of Participants With Abnormal Vital Sign Measurements | Body Temperature (<35.6 °Celsius) | 6 Participants |
| Vonoprazan 10 mg | Number of Participants With Abnormal Vital Sign Measurements | Pulse (<50 bpm) | 1 Participants |
| Vonoprazan 20 mg | Number of Participants With Abnormal Vital Sign Measurements | Pulse (>120 bpm) | 1 Participants |
| Vonoprazan 20 mg | Number of Participants With Abnormal Vital Sign Measurements | Body Temperature (<35.6 °Celsius) | 3 Participants |
| Vonoprazan 20 mg | Number of Participants With Abnormal Vital Sign Measurements | Body Temperature (>37.7 °Celsius) | 1 Participants |
| Vonoprazan 20 mg | Number of Participants With Abnormal Vital Sign Measurements | Systolic Blood Pressure (<85 mmHg) | 0 Participants |
| Vonoprazan 20 mg | Number of Participants With Abnormal Vital Sign Measurements | Diastolic Blood Pressure (<50 mmHg) | 2 Participants |
| Vonoprazan 20 mg | Number of Participants With Abnormal Vital Sign Measurements | Diastolic Blood Pressure (>110 mmHg) | 0 Participants |
| Vonoprazan 20 mg | Number of Participants With Abnormal Vital Sign Measurements | Pulse (<50 bpm) | 4 Participants |
| Lansoprazole 15 mg | Number of Participants With Abnormal Vital Sign Measurements | Body Temperature (<35.6 °Celsius) | 12 Participants |
| Lansoprazole 15 mg | Number of Participants With Abnormal Vital Sign Measurements | Diastolic Blood Pressure (>110 mmHg) | 0 Participants |
| Lansoprazole 15 mg | Number of Participants With Abnormal Vital Sign Measurements | Body Temperature (>37.7 °Celsius) | 0 Participants |
| Lansoprazole 15 mg | Number of Participants With Abnormal Vital Sign Measurements | Pulse (>120 bpm) | 0 Participants |
| Lansoprazole 15 mg | Number of Participants With Abnormal Vital Sign Measurements | Pulse (<50 bpm) | 3 Participants |
| Lansoprazole 15 mg | Number of Participants With Abnormal Vital Sign Measurements | Diastolic Blood Pressure (<50 mmHg) | 1 Participants |
| Lansoprazole 15 mg | Number of Participants With Abnormal Vital Sign Measurements | Systolic Blood Pressure (<85 mmHg) | 0 Participants |
Secondary
Number of Participants With Adverse Events (AEs)
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.
Time frame: From Day 1 to 14 days after the last dose of study medication (up to 26 weeks)
Population: Safety analysis set included all participants who took at least 1 dose of the Maintenance Phase drug and was based on the treatment received in the Maintenance Phase.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Vonoprazan 10 mg | Number of Participants With Adverse Events (AEs) | 157 Participants |
| Vonoprazan 20 mg | Number of Participants With Adverse Events (AEs) | 156 Participants |
| Lansoprazole 15 mg | Number of Participants With Adverse Events (AEs) | 158 Participants |
Secondary
Percentage of Participants With Recurrence of Erosive Esophagitis After 12 Weeks of Treatment in the Maintenance Phase
Erosive esophagitis recurrence is defined as endoscopically confirmed to have erosive esophagitis (LA classification grades A to D) during the Maintenance Phase (12 weeks). Grade A: \>/=1 mucosal breaks \</=5 mm, none of which extends between the tops of the mucosal folds; Grade B: \>/=1 mucosal breaks \>5 mm, none of which extends between the tops of two mucosal folds; Grade C: mucosal breaks that extend between the tops of two or more mucosal folds, but which involve \<75% of esophageal circumference; Grade D: mucosal breaks which involve \>/=75% of esophageal circumference.
Time frame: 12 weeks
Population: Full analysis set included all randomized participants who received at least 1 dose of the Maintenance Phase drug and had at least 1 post-baseline endoscopy, and was based on randomized treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vonoprazan 10 mg | Percentage of Participants With Recurrence of Erosive Esophagitis After 12 Weeks of Treatment in the Maintenance Phase | 27.8 percentage of participants |
| Vonoprazan 20 mg | Percentage of Participants With Recurrence of Erosive Esophagitis After 12 Weeks of Treatment in the Maintenance Phase | 10.0 percentage of participants |
| Lansoprazole 15 mg | Percentage of Participants With Recurrence of Erosive Esophagitis After 12 Weeks of Treatment in the Maintenance Phase | 35.0 percentage of participants |