Efficacy and Safety of Vonoprazan Compared to Lansoprazole in the Maintenance Treatment of Erosive Esophagitis

• Sponsor: Takeda (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02388737
• Collaborator: (none)
• Enrollment: 703
• Locations: 72
• Arms: 3
• Actual Duration (Months): 45
• Patients Per Site: 9.8
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Erosive Esophagitis	Drug: Vonoprazan; Drug: Lansoprazole; Drug: Vonoprazan Placebo; Drug: Lansoprazole Placebo	Phase 3

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 703 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Randomized, Double-Blind, Double-Dummy, Parallel-group Phase 3 Study to Evaluate the Efficacy and Safety of Oral Once-Daily Administration of TAK-438 10 or 20 mg Compared to Lansoprazole 15 mg in the Maintenance Treatment of Subjects With Endoscopic Healing of Erosive Esophagitis
• Actual Study Start Date: Apr 1, 2015
• Actual Primary Completion Date: Dec 24, 2018
• Actual Study Completion Date: Dec 31, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: Vonoprazan; Vonoprazan tablets; Other Names: TAK-438 ; Drug: Lansoprazole; Lansoprazole capsules or tablets; Other Names: Prevacid ; Drug: Vonoprazan Placebo; Vonoprazan placebo-matching tablets; Drug: Lansoprazole Placebo; Lansoprazole placebo-matching capsules
Experimental: 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	Drug: Vonoprazan; Vonoprazan tablets; Other Names: TAK-438 ; Drug: Lansoprazole; Lansoprazole capsules or tablets; Other Names: Prevacid ; Drug: Vonoprazan Placebo; Vonoprazan placebo-matching tablets; Drug: Lansoprazole Placebo; Lansoprazole placebo-matching capsules
Active Comparator: 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.	Drug: Lansoprazole; Lansoprazole capsules or tablets; Other Names: Prevacid ; Drug: Vonoprazan Placebo; Vonoprazan placebo-matching tablets

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. Change From Baseline in Serum Gastrin [Baseline and Weeks 4, 12 and 24]

7. Change From Baseline in Serum Pepsinogen I [Baseline and Weeks 4, 12 and 24]

8. Change From Baseline in Serum Pepsinogen II [Baseline and Weeks 4, 12 and 24]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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:

19. Creatinine levels: >2 mg/dL (>177 μmol/L).

20. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST), or total bilirubin levels: > upper limit of normal (ULN).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beijing Chao Yang Hospital	Beijing	Beijing	China	100020
2	Peking Union Medical College Hospital	Beijing	Beijing	China	100032
3	Peking University First Hospital	Beijing	Beijing	China	100034
4	The General Hospital of Peoples Armed Police Forces China	Beijing	Beijing	China	100039
5	Beijing Tongren Hospital, Capital Medical Univeristy	Beijing	Beijing	China	100370
6	Fuzhou General Hospital of Nanjing Military Command	Fuzhou	Fujian	China	350100
7	Guangdong General Hospital	Guangzhou	Guangdong	China	510080
8	The Sixth Affiliated Hospital of Sun Yat- Sen University	Guangzhou	Guangdong	China	510655
9	Peking University Shenzhen Hospital	Shenzhen	Guangdong	China	518000
10	Union Hospital of Tongji Medical College of Huazhong Science and Techology University	Wuhan	Hubei	China	430022
11	Tongji Hospital, Tongji Medical College, Huazhong University of Science & Techology	Wuhan	Hubei	China	430030
12	Peoples Hospital of Wuhan University	Wuhan	Hubei	China	430060
13	The 2nd Xiangya Hospital Central South University	Changsha	Hunan	China	410011
14	Chenzhou No.1 People's Hospital	Chenzhou	Hunan	China	432000
15	Xiangtan Central Hospital	Xiangtan	Hunan	China	411100
16	The First People's Hospital of Changzhou	Changzhou City	Jiangsu	China	213003
17	Jiangsu Province People's Hospital	Nanjing	Jiangsu	China	210029
18	Yangzhou 1st Hospital	Yangzhou	Jiangsu	China	225001
19	No.2 Hospital Affiliated to Jilin University	Changchun	Jilin	China	130041
20	China-Japan Union Hospital of Jilin University	Jilin	Jilin	China	130033
21	Jilin central Hospital	Jilin	Jilin	China	132011
22	Jilin Siping Central Hospital	Siping	Jilin	China	136000
23	General Hospital of Ningxia Medical University	Yinchuan	Ningxia	China	750004
24	Ruijin Hospital, Shanghai Jiaotong Uni. School of Med.	Shanghai	Shanghai	China	200025
25	Zhongshan Hospital Fudan University	Shanghai	Shanghai	China	200032
26	TongJi Hospital of Tongji University	Shanghai	Shanghai	China	200065
27	Sixth Peoples Hospital of Shanghai	Shanghai	Shanghai	China	200233
28	Tianjin Medical University General Hospital	Tianjing	Tianjin	China	300052
29	The 2nd Hospital of Tianjin Medical University	Tianjin	Tianjin	China	300211
30	The First Affiated Hospital of Kunming Medical College	Kunming	Yunnan	China	650032
31	2nd Affiliated Hospital, Zhejiang Univ. School of Medicine	Hangzhou	Zhejiang	China	310009
32	Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine	Hangzhou	Zhejiang	China	310016
33	Beijing Friendship Hospital, Capital Medical University	Beijing		China	100050
34	PLA.The Military General Hospital of Beijing	Beijing		China	100853
35		Beijing		China
36	The Second Affiliated Hospital of Chongqing Medical University	Chongqing		China	0
37	The First Affiliated Hospital, Sun Yat-sen University	Guangzhou		China	510080
38	1st Affiliated Hospital of Zhejiang University	Hangzhou		China
39	The First Affiliated Hospital of NanChang University	Nanchang		China
40	The Affiliated DrumTower Hospital of Nanjing University	Nanjing		China	210008
41		Tianjing		China
42	Seoul National University Bundang Hospital	Seongnam-si	Gyeonggi-do	Korea, Republic of	13620
43	Seoul National University Hospital	Seoul	Gyeonggi-do	Korea, Republic of	03080
44	Kyungpook National University Medical Center	Daegu	Gyeongsangbuk-do	Korea, Republic of	41404
45	Wonkwang University School Of Medicine & Hospital	Iksan-si	Jeollabuk-do	Korea, Republic of	54538
46	Pusan National University Hospital	Busan		Korea, Republic of	49241
47	Yeungnam University Hospital	Daegu		Korea, Republic of	42415
48	Kyung Hee University Hospital	Seoul		Korea, Republic of	02447
49	Korea University Anam Hospital	Seoul		Korea, Republic of	02841
50	Kangbuk Samsung Hospital	Seoul		Korea, Republic of	03181
51	Asan Medical Center	Seoul		Korea, Republic of	05505
52	Samsung Medical Center	Seoul		Korea, Republic of	06351
53	The Catholic University of Korea, Seoul St. Marys Hospital	Seoul		Korea, Republic of	06591
54	Hospital Sultana Bahiyah	Alor Setar	Kedah	Malaysia	5460
55	Hospital Raja Perempuan Zainab II	Kota Bahru	Kelantan	Malaysia	15586
56	Hospital Tengku Ampuan Afzan	Kuantan	Pahang	Malaysia	25100
57	Hospital Queen Elizabeth	Kota Kinabalu	Sabah	Malaysia	88586
58	Hospital Ampang	Ampang	Selangor	Malaysia	68000
59	Hospital Universiti Sains Malaysia	Kelantan		Malaysia	16150
60	Hospital Kuala Lumpur	Kuala Lumpur		Malaysia	50586
61	University Malaya Medical Centre	Kuala Lumpur		Malaysia	59100
62	Kaohsiung Medical University Chung-Ho Memorial Hospital	Kaohsiung		Taiwan	807
63	E-Da Hospital	Kaohsiung		Taiwan	824
64	Kaohsiung Chang Gung Memorial Hospital	Kaohsiung		Taiwan	833
65	China Medical University Hospital	Taichung		Taiwan	333
66	Chung Shan Medical University Hospital	Taichung		Taiwan	402
67	National Cheng Kung University Hospital	Tainan		Taiwan	704
68	Taipei Medical University Hospital	Taipei City		Taiwan	110
69	National Taiwan University Hospital	Taipei		Taiwan	100
70	Taipei Veterans General Hospital	Taipei		Taiwan	112
71	Tri-Service General Hospital	Taipei		Taiwan	144
72	Chang Gung Memorial Hospital, Linkou	Taoyuan County		Taiwan	333

Sponsors and Collaborators

• Takeda

Investigators

• Study Director: Medical Director Clinical Science, MD, Takeda Development Center Asia, Pte Ltd.

Study Documents (Full-Text)

• Statistical Analysis Plan - Jan 8, 2019
• Study Protocol - Nov 15, 2016

More Information

Publications

None provided.

• Responsible Party: Takeda
• ClinicalTrials.gov Identifier: NCT02388737
• Other Study ID Numbers: TAK-438_305; U1111-1136-5706; CTR20150039
• First Posted: Mar 17, 2015
• Last Update Posted: Feb 21, 2020
• Last Verified: Feb 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by Takeda: Drug therapy
• Additional relevant MeSH terms: Esophagitis; Lansoprazole; Dexlansoprazole

Study Results

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 Detail	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).

Arm/Group Title	Vonoprazan 10 mg	Vonoprazan 20 mg	Lansoprazole 15 mg
Arm/Group Description	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.	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.	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.
Period Title: Overall Study
STARTED	235	226	242
COMPLETED	181	166	180
NOT COMPLETED	54	60	62

Baseline Characteristics

Arm/Group Title	Vonoprazan 10 mg	Vonoprazan 20 mg	Lansoprazole 15 mg	Total
Arm/Group Description	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.	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.	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.	Total of all reporting groups
Overall Participants	235	226	242	703
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	51.7 (11.79)	52.8 (13.02)	54.0 (12.80)	52.8 (12.56)
Sex: Female, Male (Count of Participants)
Female	59 25.1%	61 27%	64 26.4%	184 26.2%
Male	176 74.9%	165 73%	178 73.6%	519 73.8%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%
Asian	235 100%	225 99.6%	242 100%	702 99.9%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%	0 0%
White	0 0%	0 0%	0 0%	0 0%
More than one race	0 0%	1 0.4%	0 0%	1 0.1%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%
Region of Enrollment (Count of Participants)
China	163 69.4%	159 70.4%	169 69.8%	491 69.8%
Malaysia	24 10.2%	24 10.6%	24 9.9%	72 10.2%
Korea, Republic Of	26 11.1%	23 10.2%	27 11.2%	76 10.8%
Taiwan, Province Of China	22 9.4%	20 8.8%	22 9.1%	64 9.1%
Height (centimeter (cm)) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [centimeter (cm)]	166.7 (8.35)	166.1 (8.31)	167.1 (8.01)	166.7 (8.22)
Weight (kilogram (kg)) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kilogram (kg)]	70.03 (12.137)	68.10 (11.314)	69.19 (11.075)	69.12 (11.528)
Body Mass Index (BMI) (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	25.10 (3.449)	24.58 (3.052)	24.77 (3.475)	24.82 (3.338)
Smoking Classification (Count of Participants)
The Participant Has Never Smoked	157 66.8%	135 59.7%	147 60.7%	439 62.4%
The Participant Is a Current Smoker	50 21.3%	47 20.8%	55 22.7%	152 21.6%
The Participant Is an Ex-smoker	28 11.9%	44 19.5%	40 16.5%	112 15.9%
Consumption of Alcohol (Count of Participants)
Drink Everyday	11 4.7%	12 5.3%	16 6.6%	39 5.5%
Drink a Couple of Days Per Week	28 11.9%	19 8.4%	29 12%	76 10.8%
Drink a Couple of Days Per Month	53 22.6%	48 21.2%	41 16.9%	142 20.2%
Never Drink	143 60.9%	147 65%	156 64.5%	446 63.4%
Consumption of Caffeine (Count of Participants)
Yes	37 15.7%	34 15%	43 17.8%	114 16.2%
No	198 84.3%	192 85%	199 82.2%	589 83.8%
History of H.pylori Eradication Therapy (Count of Participants)
Yes (End of Treatment: Within Past 1 Year)	6 2.6%	9 4%	11 4.5%	26 3.7%
Yes (End of Treatment: More than 1 Year)	20 8.5%	19 8.4%	16 6.6%	55 7.8%
No	209 88.9%	198 87.6%	215 88.8%	622 88.5%
LA Classification (Time of Diagnosis) (Count of Participants)
Grade A	91 38.7%	96 42.5%	93 38.4%	280 39.8%
Grade B	94 40%	84 37.2%	100 41.3%	278 39.5%
Grade C	42 17.9%	39 17.3%	38 15.7%	119 16.9%
Grade D	8 3.4%	7 3.1%	11 4.5%	26 3.7%
Grade A/B	185 78.7%	180 79.6%	193 79.8%	558 79.4%
Grade C/D	50 21.3%	46 20.4%	49 20.2%	145 20.6%
Barrett's Mucosa (Baseline) (Count of Participants)
Present (3 cm or Greater)	3 1.3%	0 0%	3 1.2%	6 0.9%
Present (Less than 3 cm)	16 6.8%	24 10.6%	16 6.6%	56 8%
Absent	212 90.2%	197 87.2%	218 90.1%	627 89.2%
Unknown	4 1.7%	5 2.2%	4 1.7%	13 1.8%
Esophageal Hiatal Hernia (Baseline) (Count of Participants)
Present (2 cm or Greater)	27 11.5%	22 9.7%	23 9.5%	72 10.2%
Present (Less than 2 cm)	30 12.8%	22 9.7%	29 12%	81 11.5%
Absent	174 74%	179 79.2%	184 76%	537 76.4%
Unknown	4 1.7%	3 1.3%	5 2.1%	12 1.7%
HRQoL (EQ-5D-5L) (score on scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [score on scale]	0.9723 (0.04610)	0.9723 (0.05252)	0.9696 (0.06227)	0.9713 (0.05410)
EQ VAS Score (Baseline) (score on scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [score on scale]	88.2 (11.10)	89.3 (8.85)	89.4 (9.03)	89.0 (9.71)

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants With Recurrence of Erosive Esophagitis as Confirmed on Endoscopy After the 24-week Maintenance Phase
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Vonoprazan 10 mg	Vonoprazan 20 mg	Lansoprazole 15 mg
Arm/Group Description	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.	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.	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.
Measure Participants	235	226	242
Number (95% Confidence Interval) [percentage of participants]	13.3 5.7%	12.3 5.4%	25.5 10.5%

2. Secondary Outcome

Title	Percentage of Participants With Recurrence of Erosive Esophagitis After 12 Weeks of Treatment in the Maintenance Phase
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Vonoprazan 10 mg	Vonoprazan 20 mg	Lansoprazole 15 mg
Arm/Group Description	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.	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.	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.
Measure Participants	235	226	242
Number (95% Confidence Interval) [percentage of participants]	27.8 11.8%	10.0 4.4%	35.0 14.5%

3. Secondary Outcome

Title	Number of Participants With Adverse Events (AEs)
Description	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)

Outcome Measure Data

Analysis Population Description

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/Group Title	Vonoprazan 10 mg	Vonoprazan 20 mg	Lansoprazole 15 mg
Arm/Group Description	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.	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.	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.
Measure Participants	235	226	242
Count of Participants [Participants]	157 66.8%	156 69%	158 65.3%

4. Secondary Outcome

Title	Number of Participants With Abnormal Clinical Laboratory Findings
Description	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)

Outcome Measure Data

Analysis Population Description

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/Group Title	Vonoprazan 10 mg	Vonoprazan 20 mg	Lansoprazole 15 mg
Arm/Group Description	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.	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.	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.
Measure Participants	235	226	242
Hematology: Red Blood Cells (>1.2xULN)	1 0.4%	0 0%	1 0.4%
Hematology: White Blood Cells (>1.5xULN)	0 0%	0 0%	1 0.4%
Hematology: Hemoglobin (<0.8xLLN)	1 0.4%	1 0.4%	1 0.4%
Hematology: Hematocrit (<0.8xLLN)	0 0%	1 0.4%	1 0.4%
Hematology: Platelets (<75x10^9/L)	0 0%	1 0.4%	0 0%
Hematology: Neutrophils (<0.5xLLN)	1 0.4%	0 0%	0 0%
Hematology: Eosinophils (>2xULN)	2 0.9%	2 0.9%	0 0%
Hematology: Lymphocytes (>1.5xULN)	1 0.4%	0 0%	0 0%
Serum Chemistry: ALT (>3xULN)	1 0.4%	1 0.4%	0 0%
Serum Chemistry: AST (>3xULN)	2 0.9%	0 0%	2 0.8%
Serum Chemistry: GGT (>3xULN)	4 1.7%	2 0.9%	7 2.9%
Serum Chemistry: CK (CPK) (>5xULN)	4 1.7%	2 0.9%	3 1.2%
Serum Chemistry: Albumin (<25 g/L)	0 0%	0 0%	1 0.4%
Serum Chemistry: Creatinine (>177 umol/L)	0 0%	0 0%	1 0.4%
Serum Chemistry: BUN (>10.7 mmol/L)	2 0.9%	4 1.8%	2 0.8%
Serum Chemistry: Uric Acid (>0.773 mmol/L)	0 0%	1 0.4%	0 0%
Serum Chemistry: Total Cholesterol (>7.72 mmol/L)	2 0.9%	5 2.2%	3 1.2%
Serum Chemistry: Triglycerides (>2.5xULN)	2 0.9%	5 2.2%	6 2.5%
Serum Chemistry: Glucose (<2.8 mmol/L)	1 0.4%	0 0%	1 0.4%
Serum Chemistry: Glucose (>19.4 mmol/L)	1 0.4%	0 0%	0 0%
Serum Chemistry: Potassium (<3.0 mmol/L)	0 0%	0 0%	1 0.4%
Serum Chemistry: Sodium (>150 mmol/L)	1 0.4%	0 0%	0 0%
Serum Chemistry: Vitamin B12 (<92 pmol/L)	1 0.4%	0 0%	3 1.2%

5. Secondary Outcome

Title	Number of Participants With Abnormal Electrocardiogram (ECG) Findings
Description	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)

Outcome Measure Data

Analysis Population Description

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/Group Title	Vonoprazan 10 mg	Vonoprazan 20 mg	Lansoprazole 15 mg
Arm/Group Description	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.	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.	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.
Measure Participants	235	226	242
Heart Rate (<50 bpm)	8 3.4%	7 3.1%	4 1.7%
Heart Rate (>120 bpm)	0 0%	1 0.4%	0 0%
QT Interval (>=460 msec)	9 3.8%	5 2.2%	8 3.3%
QTcF Interval (>= 500, or >= 450 with CHG >= 30)	8 3.4%	3 1.3%	6 2.5%

6. Secondary Outcome

Title	Number of Participants With Abnormal Vital Sign Measurements
Description	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)

Outcome Measure Data

Analysis Population Description

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/Group Title	Vonoprazan 10 mg	Vonoprazan 20 mg	Lansoprazole 15 mg
Arm/Group Description	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.	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.	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.
Measure Participants	235	226	242
Body Temperature (<35.6 °Celsius)	6 2.6%	3 1.3%	12 5%
Body Temperature (>37.7 °Celsius)	0 0%	1 0.4%	0 0%
Systolic Blood Pressure (<85 mmHg)	2 0.9%	0 0%	0 0%
Diastolic Blood Pressure (<50 mmHg)	0 0%	2 0.9%	1 0.4%
Diastolic Blood Pressure (>110 mmHg)	1 0.4%	0 0%	0 0%
Pulse (<50 bpm)	1 0.4%	4 1.8%	3 1.2%
Pulse (>120 bpm)	1 0.4%	1 0.4%	0 0%

7. Secondary Outcome

Title	Change From Baseline in Serum Gastrin
Time Frame	Baseline and Weeks 4, 12 and 24

Outcome Measure Data

Analysis Population Description

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/Group Title	Vonoprazan 10 mg	Vonoprazan 20 mg	Lansoprazole 15 mg
Arm/Group Description	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.	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.	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.
Measure Participants	235	226	242
Baseline	20.42 (33.969)	17.97 (21.458)	21.94 (27.905)
Change at Week 4	10.09 (37.747)	22.76 (36.053)	-11.21 (24.651)
Change at Week 12	14.45 (29.439)	31.92 (45.127)	-8.76 (24.578)
Change at Week 24	17.47 (39.847)	37.60 (47.172)	-7.41 (22.210)

8. Secondary Outcome

Title	Change From Baseline in Serum Pepsinogen I
Time Frame	Baseline and Weeks 4, 12 and 24

Outcome Measure Data

Analysis Population Description

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/Group Title	Vonoprazan 10 mg	Vonoprazan 20 mg	Lansoprazole 15 mg
Arm/Group Description	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.	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.	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.
Measure Participants	235	226	242
Baseline	287.1 (249.41)	276.3 (203.46)	303.3 (253.76)
Change at Week 4	40.5 (266.92)	139.8 (269.08)	-112.3 (245.22)
Change at Week 12	-3.1 (267.65)	89.9 (285.05)	-123.5 (252.45)
Change at Week 24	5.9 (289.91)	55.4 (279.65)	-103.9 (218.80)

9. Secondary Outcome

Title	Change From Baseline in Serum Pepsinogen II
Time Frame	Baseline and Weeks 4, 12 and 24

Outcome Measure Data

Analysis Population Description

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/Group Title	Vonoprazan 10 mg	Vonoprazan 20 mg	Lansoprazole 15 mg
Arm/Group Description	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.	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.	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.
Measure Participants	235	226	242
Baseline	22.9 (22.42)	22.1 (17.40)	24.6 (23.83)
Change at Week 4	3.8 (27.34)	16.5 (25.56)	-10.9 (23.98)
Change at Week 12	-1.6 (24.02)	9.0 (26.40)	-10.9 (24.41)
Change at Week 24	-0.6 (27.23)	5.8 (25.59)	-8.7 (19.61)

Adverse Events

Time Frame	Up to 26 weeks
Adverse Event Reporting Description	At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Arm/Group Title	Vonoprazan 10 mg		Vonoprazan 20 mg		Lansoprazole 15 mg
Arm/Group Description	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.		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.		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.
All Cause Mortality
	Vonoprazan 10 mg		Vonoprazan 20 mg		Lansoprazole 15 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/235 (0%)		0/226 (0%)		1/242 (0.4%)
Serious Adverse Events
	Vonoprazan 10 mg		Vonoprazan 20 mg		Lansoprazole 15 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	10/235 (4.3%)		8/226 (3.5%)		12/242 (5%)
Cardiac disorders
Arteriosclerosis coronary artery	1/235 (0.4%)		0/226 (0%)		1/242 (0.4%)
Acute myocardial infarction	0/235 (0%)		0/226 (0%)		1/242 (0.4%)
Angina unstable	0/235 (0%)		0/226 (0%)		1/242 (0.4%)
Hypertensive heart disease	0/235 (0%)		1/226 (0.4%)		0/242 (0%)
Eye disorders
Iridocyclitis	1/235 (0.4%)		0/226 (0%)		0/242 (0%)
Gastrointestinal disorders
Gastrointestinal haemorrhage	1/235 (0.4%)		0/226 (0%)		0/242 (0%)
Inguinal hernia	0/235 (0%)		0/226 (0%)		1/242 (0.4%)
Hepatobiliary disorders
Cholelithiasis	0/235 (0%)		0/226 (0%)		1/242 (0.4%)
Infections and infestations
Arthritis infective	0/235 (0%)		1/226 (0.4%)		0/242 (0%)
Gastroenteritis	0/235 (0%)		1/226 (0.4%)		0/242 (0%)
Herpes zoster	1/235 (0.4%)		0/226 (0%)		0/242 (0%)
Lung infection	0/235 (0%)		0/226 (0%)		1/242 (0.4%)
Peritonsillar abscess	0/235 (0%)		0/226 (0%)		1/242 (0.4%)
Pneumonia	0/235 (0%)		0/226 (0%)		1/242 (0.4%)
Typhoid fever	0/235 (0%)		0/226 (0%)		1/242 (0.4%)
Injury, poisoning and procedural complications
Fracture displacement	0/235 (0%)		0/226 (0%)		1/242 (0.4%)
Head injury	0/235 (0%)		0/226 (0%)		1/242 (0.4%)
Spinal column injury	0/235 (0%)		1/226 (0.4%)		0/242 (0%)
Musculoskeletal and connective tissue disorders
Gouty arthritis	0/235 (0%)		1/226 (0.4%)		0/242 (0%)
Gouty tophus	0/235 (0%)		1/226 (0.4%)		0/242 (0%)
Osteoarthritis	1/235 (0.4%)		0/226 (0%)		0/242 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric adenoma	0/235 (0%)		1/226 (0.4%)		0/242 (0%)
Large intestine benign neoplasm	1/235 (0.4%)		0/226 (0%)		0/242 (0%)
Pancreatic carcinoma	0/235 (0%)		1/226 (0.4%)		0/242 (0%)
Parathyroid tumour benign	0/235 (0%)		0/226 (0%)		1/242 (0.4%)
Thyroid cancer	1/235 (0.4%)		0/226 (0%)		0/242 (0%)
Uterine leiomyoma	0/235 (0%)		1/226 (0.4%)		0/242 (0%)
Nervous system disorders
Cerebral infarction	1/235 (0.4%)		0/226 (0%)		0/242 (0%)
Ruptured cerebral aneurysm	0/235 (0%)		1/226 (0.4%)		0/242 (0%)
Trigeminal neuralgia	0/235 (0%)		0/226 (0%)		1/242 (0.4%)
Renal and urinary disorders
Calculus ureteric	2/235 (0.9%)		0/226 (0%)		0/242 (0%)
Nephrolithiasis	1/235 (0.4%)		0/226 (0%)		0/242 (0%)
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease	0/235 (0%)		0/226 (0%)		1/242 (0.4%)
Laryngeal cyst	1/235 (0.4%)		0/226 (0%)		0/242 (0%)
Vascular disorders
Hypertension	1/235 (0.4%)		0/226 (0%)		0/242 (0%)
Other (Not Including Serious) Adverse Events
	Vonoprazan 10 mg		Vonoprazan 20 mg		Lansoprazole 15 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	81/235 (34.5%)		79/226 (35%)		79/242 (32.6%)
Gastrointestinal disorders
Diarrhoea	15/235 (6.4%)		21/226 (9.3%)		17/242 (7%)
Dyspepsia	18/235 (7.7%)		10/226 (4.4%)		12/242 (5%)
Gastric polyps	11/235 (4.7%)		12/226 (5.3%)		8/242 (3.3%)
Abdominal distension	5/235 (2.1%)		6/226 (2.7%)		13/242 (5.4%)
Infections and infestations
Upper respiratory tract infection	30/235 (12.8%)		29/226 (12.8%)		21/242 (8.7%)
Nasopharyngitis	12/235 (5.1%)		12/226 (5.3%)		11/242 (4.5%)
Investigations
Alanine aminotransferase increased	13/235 (5.5%)		9/226 (4%)		16/242 (6.6%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.