Efficacy and Safety of Vonoprazan Compared to Lansoprazole in Participants With Erosive Esophagitis

A Phase 3, Randomized, Double-Blind, Two Phase, Multicenter Study to Evaluate the Efficacy and Safety of Vonoprazan 20 mg Compared to Lansoprazole 30 mg for Healing in Patients With Erosive Esophagitis and to Evaluate the Efficacy and Safety of Vonoprazan (10 mg and 20 mg) Compared to Lansoprazole 15 mg for the Maintenance of Healing in Patients With Healed Erosive Esophagitis

To evaluate the efficacy and safety of vonoprazan compared to lansoprazole in participants with erosive esophagitis.

Study Overview

• Status: Completed
• Conditions: Erosive Esophagitis
• Intervention / Treatment: Drug: Vonoprazan; Drug: Lansoprazole

• Study Type: Interventional
• Enrollment (Actual): 1027
• Phase: Phase 3

Contacts and Locations

Study Locations

• Bulgaria
  • Blagoevgrad, Bulgaria, 2700
    • Multiprofile Hospital for Active Treatment Puls AD - PPDS
  • Pleven, Bulgaria, 5800
    • University Multiprofile Hospital for Active Treatment
  • Sofia, Bulgaria, 1202
    • Second Multiprofile Hospital for Active Treatment Sofia
  • Sofia, Bulgaria, 1407
    • Medical Center Excelsior OOD - PPDS
  • Sofia, Bulgaria, 1431
    • Diagnostic-Consultative Center Aleksandrovska EOOD
  • Sofia, Bulgaria, 1784
    • Synexus - Medical Center Synexus Sofia EOOD
  • Stara Zagora, Bulgaria, 6003
    • Synexus - Medical Centre Synexus Sofia EOOD
  • Sofia City
    • Sofia, Sofia City, Bulgaria, 1606
      • Fourth Multiprofile Hospital for Active Treatment
• Czechia
  • Olomouc, Czechia, 779 00
    • PreventaMed s.r.o.
  • Prague, Czechia, 120 00
    • Synexus Czech s.r.o.
  • Usti nad Labem, Czechia, 401 13
    • Krajska zdravotni, a.s. - Masarykova nemocnice v Usti nad Labem, o.z. Oddeleni gastroenterolgie
  • Pardubice
    • Usti nad Orlici, Pardubice, Czechia, 562 18
      • Nemocnice Pardubickeho kraje, a.s. Orlickoustecka nemocnice, Interni oddeleni, Cs.
  • Prague
    • Praha, Prague, Czechia, 190 00
      • MEDIC KRAL s.r.o.
• Hungary
  • Budapest, Hungary, 1036
    • Synexus (DRS) - Synexus Magyarország Kft. Budapest
  • Debrecen, Hungary, 4025
    • Synexus Affiliate - Synexus Magyarorszag Kft. Debrecen
  • Gyula, Hungary, 5700
    • Synexus (DRS) - Synexus Magyarország Kft. Gyula
  • Zalaegerszeg, Hungary, 8900
    • Synexus (DRS) - Synexus Magyarország Kft. Zalaegerszeg
  • Hajdú-Bihar
    • Debrecen, Hajdú-Bihar, Hungary, 4032
      • Debreceni Egyetem Klinikai Kozpont Nagyerdei Krt. 98, Belgyogyaszati Klinika
  • Heves
    • Hatvan, Heves, Hungary, 3000
      • Synexus Affiliate BKS Research Kft. Hatvan
  • Szabolcs-Szatmár-Bereg
    • Nyíregyháza, Szabolcs-Szatmár-Bereg, Hungary, 4400
      • Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz
• Poland
  • Bydgoszcz, Poland, 85-168
    • Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w Bydgoszczy Centrum Endoskopii Zabiegowej - Poradnia Chorob Jelitowych
  • Bydgoszcz, Poland, 85-681
    • Gabinet Lekarski-Janusz Rudzinski ul. Powstancow Warszawy 5
  • Czestochowa, Poland, 42-202
    • Synexus - Częstochowa
  • Gdańsk, Poland, 80-382
    • Synexus - Gdansk
  • Gdynia, Poland, 81-537
    • Synexus - Gdynia
  • Katowice, Poland, 40-040
    • Synexus - Katowice
  • Kraków, Poland, 31-501
    • Synexus Affiliate - Krakowskie Centrum Medyczne
  • Ksawerów, Poland, 95-054
    • Centrum Opieki Zdrowotnej Orkan-Med Stec-Michalska Sp. J.
  • Lublin, Poland, 20-582
    • GASTRO MED Zaklad Opieki Zdrowotnej
  • Poznań, Poland, 60-702
    • Synexus - Poznań
  • Rzeszów, Poland, 35-302
    • Korczowski Bartosz, Gabinet Lekarski
  • Szczecin, Poland, 71-434
    • Twoja Przychodnia - Szczecinskie Centrum Medyczne
  • Toruń, Poland, 87-100
    • Gastromed Specjalistyczne Centrum Gastrologii i Endoskopii
  • Warszawa, Poland, 01-192
    • Synexus - Warszawa
  • Warszawa, Poland, 0-691
    • REUMATIKA - Centrum Reumatologii NZOZ
  • Wrocław, Poland, 50-449
    • Melita Medical
  • Wrocław, Poland, 50-381
    • Synexus - Wroclaw
  • Łódź, Poland, 90-127
    • Synexus - Lodz
  • Łódź, Poland, 90-302
    • SANTA FAMILIA Centrum Badan Profilaktyki i Leczenia
• United Kingdom
  • Cardiff, United Kingdom, CF15 9SS
    • Synexus - Wales Clinical Research Centre
  • Chorley, United Kingdom, PR7 7NA
    • Synexus - Lancashire Clinical Research Centre
  • Glasgow, United Kingdom, G20 0XA
    • CPS Research
  • Hexham, United Kingdom, NE46 1QJ
    • Synexus - Hexham Clinical Research Centre
  • Liverpool, United Kingdom, L22 0LG
    • Synexus - Merseyside Clinical Research Centre
  • Manchester, United Kingdom, M15 6SE
    • Synexus - Manchester Clinical Research Centre
  • Stockton-on-Tees, United Kingdom, TS19 8PE
    • Synexus - North Tees Clinical Research Centre
  • Berkshire
    • Reading, Berkshire, United Kingdom, RG2 0TG
      • Synexus Thames Valley Clinical Research Centre
  • West Midlands
    • Edgbaston, West Midlands, United Kingdom, B15 2SQ
      • Synexus - Midlands Clinical Research Centre
• United States
  • Alabama
    • Anniston, Alabama, United States, 36207
      • Pinnacle Research Group
    • Athens, Alabama, United States, 35611
      • North Alabama Research Center LLC
    • Birmingham, Alabama, United States, 35211
      • Synexus Clinical Research US, Inc.
    • Huntsville, Alabama, United States, 35801
      • Medical Affiliated Research Center Inc
  • Arizona
    • Chandler, Arizona, United States, 85224
      • Synexus Clinical Research US, Inc. - East Valley Family Physicians, PLC
    • Mesa, Arizona, United States, 85206
      • Synexus Clinical Research US, Inc. - Central Arizona Medical Associates, PC
    • Mesa, Arizona, United States, 85213
      • Synexus Clinical Research US, Inc. - Desert Clinical Research, LLC
    • Phoenix, Arizona, United States, 85018
      • Elite Clinical Studies - Phoenix - BTC - PPDS
    • Phoenix, Arizona, United States, 85018
      • Hope Research Institute LLC
    • Tucson, Arizona, United States, 85712
      • Del Sol Research Management - BTC - PPDS
  • Arkansas
    • Little Rock, Arkansas, United States, 72211
      • Preferred Research Partners - ClinEdge - PPDS
    • Little Rock, Arkansas, United States, 72212
      • Applied Research Center of Little Rock
    • North Little Rock, Arkansas, United States, 72117
      • Arkansas Gastroenterology
    • North Little Rock, Arkansas, United States, 72117
      • Atria Clinical Research - BTC - PPDS
  • California
    • Anaheim, California, United States, 92801
      • Anaheim Clinical Trials Llc
    • Chula Vista, California, United States, 91910
      • GW Research, Inc. - ClinEdge - PPDS
    • Chula Vista, California, United States, 91911
      • eStudySite - Chula Vista - PPDS
    • Corona, California, United States, 92879
      • Kindred Medical Institute for Clinical Trials, LLC
    • Fountain Valley, California, United States, 92708-7510
      • HB Clinical Trials, Inc.
    • Lancaster, California, United States, 93534
      • Om Research LLC
    • Lomita, California, United States, 90717
      • Torrance Clinical Research Institute
    • Los Angeles, California, United States, 90045
      • Southern California Research Institute Medical Group, Inc.
    • Los Angeles, California, United States, 90033
      • LA County + USC Medical Center
    • Mission Hills, California, United States, 91345
      • Facey Medical Foundation
    • Palm Springs, California, United States, 92262
      • Palmtree Clinical Research
    • San Diego, California, United States, 92123
      • Medical Associates Research Group, Inc.
    • San Diego, California, United States, 92114
      • Precision Research Institute
    • Santa Ana, California, United States, 92703
      • Paragon Rx Clinical, Inc.
  • Colorado
    • Colorado Springs, Colorado, United States, 80909
      • Synexus Clinical Research US, Inc. - Colorado Springs Family Practice
    • Wheat Ridge, Colorado, United States, 80033
      • Western States Clinical Research, Inc.
  • Connecticut
    • Bridgeport, Connecticut, United States, 06606
      • Gastroenterology Associates of Fairfield County
    • Bristol, Connecticut, United States, 06010
      • Connecticut Clinical Research Foundation
  • Florida
    • Edgewater, Florida, United States, 32132
      • Riverside Clinical Research
    • Hollywood, Florida, United States, 33024
      • Research Centers of America - ERG
    • Inverness, Florida, United States, 34452
      • Nature Coast Clinical Research
    • Jacksonville, Florida, United States, 32256
      • ENCORE Borland-Groover Clinical Research - ERN - PPDS
    • Miami, Florida, United States, 33125
      • Columbus Clinical Services LLC
    • Miami, Florida, United States, 33134
      • Jesscan Medical Research
    • Miami, Florida, United States, 33144
      • Nuren Medical and Research Center
    • Miami, Florida, United States, 33165
      • Premier Research Associate, Inc.
    • Orlando, Florida, United States, 32807
      • Gutierrez Medical Center
    • Palm Harbor, Florida, United States, 34684
      • Advanced Gastroenterology Associates, LLC
    • Palmetto Bay, Florida, United States, 33157
      • Innovation Medical Research Center
    • Pinellas Park, Florida, United States, 33781
      • Synexus Clinical Research US, Inc. - St. Petersburg
    • Sunrise, Florida, United States, 33351
      • Precision Clinical Research, LLC
    • Tampa, Florida, United States, 33614
      • Guardian Angel Research Center
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Atlanta Gastroenterology Associates
    • Atlanta, Georgia, United States, 30345
      • Nexgen Research Center
    • Macon, Georgia, United States, 31201
      • Gastroenterology Associates of Central Georgia, LLC
    • Peachtree Corners, Georgia, United States, 30071
      • In-Quest Medical Research, LLC
  • Illinois
    • Gurnee, Illinois, United States, 60031
      • Illinois Gastroenterology Group
    • Oakbrook Terrace, Illinois, United States, 60181
      • Summit Digestive & Liver Disease Specialists State Street Clinic
  • Indiana
    • Evansville, Indiana, United States, 47714
      • Medisphere Medical Research Center, Llc
    • New Albany, Indiana, United States, 47150
      • Gastroenterology Health Partners, PLLC
  • Iowa
    • Clive, Iowa, United States, 50325
      • Iowa Digestive Disease Center
  • Louisiana
    • Covington, Louisiana, United States, 70433
      • Clinical Trials Management LLC
    • Houma, Louisiana, United States, 70360
      • CroNOLA, LLC.
    • Metairie, Louisiana, United States, 70006
      • Clinical Trials Management LLC
    • Shreveport, Louisiana, United States, 71105
      • Louisiana Research Center, LLC
  • Maryland
    • Rockville, Maryland, United States, 20854
      • Meridian Clinical Research
    • Towson, Maryland, United States, 21286
      • Clinical Associates Research
  • Michigan
    • Troy, Michigan, United States, 48085
      • Oakland Medical Research Center
    • Wyoming, Michigan, United States, 49519
      • Gastroenterology Associates of Western Michigan, PLC
  • Missouri
    • Kansas City, Missouri, United States, 64114
      • The Alliance for Multispecialty Research, LLC
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine
  • Nebraska
    • Omaha, Nebraska, United States, 68134
      • Heartland Clinical Research, Inc
  • Nevada
    • Henderson, Nevada, United States, 89052
      • Synexus Clinical Research US, Inc. Site 1
    • Henderson, Nevada, United States, 89052
      • Synexus Clinical Research US, Inc. Site 2
    • Las Vegas, Nevada, United States, 89106
      • Sierra Clinical Research - ClinEdge - PPDS
    • Las Vegas, Nevada, United States, 89119
      • Site 2
    • Las Vegas, Nevada, United States, 89128
      • Las Vegas - Site 1
    • Reno, Nevada, United States, 89511
      • Advanced Research Institute
  • New York
    • Hartsdale, New York, United States, 10530
      • Drug Trials America - ClinEdge
    • Orchard Park, New York, United States, 14127
      • Southtowns Gastroenterology, PLLC
  • North Carolina
    • Charlotte, North Carolina, United States, 28215
      • Carolinas Research Center
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center
    • Greensboro, North Carolina, United States, 27408
      • Medication Management LLC
    • Greenville, North Carolina, United States, 27834
      • Carolina Research
    • High Point, North Carolina, United States, 27262
      • Peters Medical Research, LLC - ClinEdge - PPDS
    • Raleigh, North Carolina, United States, 27607
      • Carolina's GI Research, LLC
  • Ohio
    • Dayton, Ohio, United States, 45415
      • Dayton Gastroenterology, Inc
    • Franklin, Ohio, United States, 45005
      • Prestige Clinical Research
  • Oklahoma
    • Norman, Oklahoma, United States, 73071
      • Central Sooner Research
  • South Carolina
    • Anderson, South Carolina, United States, 29621
      • Synexus Clinical Research US, Inc.
    • Charleston, South Carolina, United States, 29406
      • Clinical Trials of South Carolina
    • Mount Pleasant, South Carolina, United States, 29464
      • Coastal Carolina Research Center
  • South Dakota
    • Rapid City, South Dakota, United States, 57701
      • Rapid City Medical Center LLP
  • Tennessee
    • Johnson City, Tennessee, United States, 37601
      • Multi Specialty Clinical Research
    • Nashville, Tennessee, United States, 37212
      • Vanderbilt University Medical Center
    • Nashville, Tennessee, United States, 37203
      • Clinical Research Associates Inc
  • Texas
    • Baytown, Texas, United States, 77521
      • Inquest Clinical Research
    • Dallas, Texas, United States, 75234
      • Synexus Clinical Research US, Inc. - Dallas
    • El Paso, Texas, United States, 79905
      • Texas Tech University Health Sciences Center El Paso
    • Houston, Texas, United States, 77084
      • Biopharma Informatic, LLC
    • Houston, Texas, United States, 77036
      • Precision Research Institute, LLC
    • McAllen, Texas, United States, 78503
      • Rio Grande Gastroenterology
    • Pasadena, Texas, United States, 77505
      • Digestive System Healthcare
    • Pearland, Texas, United States, 77581
      • Pearland Physicians
    • Plano, Texas, United States, 75093
      • Synexus Clinical Research US, Inc.
    • San Antonio, Texas, United States, 78229
      • Southern Star Research Institute, LLC
    • San Antonio, Texas, United States, 78209
      • Quality Research Inc
    • San Antonio, Texas, United States, 78229
      • Gastroenterology Research of San Antonio (GERSA)
  • Utah
    • Layton, Utah, United States, 84041
      • Synexus Clinical Research US, Inc.
    • Ogden, Utah, United States, 84405
      • Advanced Research Institute
  • Virginia
    • Christiansburg, Virginia, United States, 24073
      • New River Valley Research Institute
    • Fairfax, Virginia, United States, 22031
      • Verity Research, Inc.
    • Lynchburg, Virginia, United States, 24502
      • Blue Ridge Medical Research
  • Washington
    • Bellevue, Washington, United States, 98004
      • Washington Gastroenterology
    • Seattle, Washington, United States, 98104
      • Harborview Medical Center, University of Washington Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. The participant is ≥18 years of age at the time of informed consent signing.
2. In the opinion of the investigator or subinvestigators, the participant is capable of understanding and complying with protocol requirements.
3. The participant signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures. The participant is informed of the full nature and purpose of the study, including possible risks and side-effects. The participant has the ability to cooperate with the investigator. Ample time and opportunity should be given to read and understand verbal and/or written instructions.
4. The participant is found to have endoscopically confirmed EE of LA Classification Grades A to D during the Screening Period (Visit 1) as assessed by a central adjudicator. The target number of participants with LA classification Grade C or D will be approximately 30% of the total number of participants (300 total). Enrollment of EE participants with Grade A or B will end when the number of participants with Grade A or B EE is approximately 700 or 70% of the total planned number of participants. Given the invasive nature of an endoscopy, any endoscopic confirmation performed in a routine clinical setting before signing the informed consent will be acceptable to use for the purpose of fulfilling the screening requirement if all of the following apply: (1) appropriate endoscopy pictures were taken; (2) appropriate gastric biopsy samples were taken; (3) the endoscopy pictures can be sent to the central adjudicator via the adjudication systems; and (4) all screening procedures (including the completion of adjudication) AND randomization can be completed within a 7-day period after the date of the endoscopy.
5. A female participant of childbearing potential who is or may be sexually active with a nonsterilized male partner agrees to routinely use adequate contraception from the signing of informed consent until 4 weeks after the last dose of study drug.

Exclusion Criteria:

1. The participant's endoscopic examination for entering this study fails to confirm EE within 7 days (no later than 10 days on rare occasion with sponsor approval) prior to randomization.
2. The participant is determined to be positive for Helicobacter pylori (HP) or has had an HP infection within 45 days of randomization.
3. The participant has endoscopic Barrett's esophagus (>1 cm of columnar-lined esophagus) and/or definite dysplastic changes in the esophagus.
4. The participant has any other condition affecting the esophagus, including eosinophilic esophagitis; esophageal varices; viral or fungal infection; esophageal stricture; a history of radiation therapy, radiofrequency ablation, endoscopic mucosal resection, or cryotherapy to the esophagus; or any history of caustic or physiochemical trauma (including sclerotherapy or esophageal variceal band ligation). However, participants diagnosed with Schatzki's ring (mucosal tissue ring around lower esophageal sphincter) are eligible to participate.
5. The participant has scleroderma (systemic sclerosis).
6. The participant has a history of surgery or endoscopic treatment affecting gastroesophageal reflux, including fundoplication and dilation for esophageal stricture (except Schatzki's ring) or a history of gastric or duodenal surgery (except endoscopic removal of benign polyps).
7. The participant has an active gastric or duodenal ulcer at the start of the Screening Period. Additionally, participants with gastric or duodenal erosions are permitted to participate.
8. The participant has received any investigational compound (including those in post marketing studies) within 30 days prior to the start of the Screening Period. A participant who has been screen failed from another clinical study and who has not been dosed may be considered for enrollment in this study.
9. The participant is a study site employee, an immediate family member, or is in a dependent relationship with a study site employee who is involved in the conduct of this study (eg, spouse, parent, child, sibling) or who may have consented under duress.
10. The participant has cutaneous lupus erythematosus or systemic lupus erythematosus.
11. The participant has had clinically significant upper or lower gastrointestinal bleeding within 4 weeks prior to randomization.
12. The participant has Zollinger-Ellison syndrome or other gastric acid hypersecretory conditions.
13. The participant has a history of hypersensitivity or allergies to vonoprazan (including the formulation excipients: D-mannitol, microcrystalline cellulose, hydroxypropyl cellulose, fumaric acid, croscarmellose sodium, magnesium stearate, hypromellose, macrogol 8000, titanium oxide, or red or yellow ferric oxide), PPIs, or any excipients used in the 13C-urea breath test: mannitol, citric acid, or aspartame. Skin testing may be performed according to local standard practice to confirm hypersensitivity.
14. The participant has a history of alcohol abuse, illegal drug use, or drug addiction within the 12 months prior to screening, or regularly consumes >21 units of alcohol (1 unit = 12 oz/300 mL beer, 1.5 oz/25 mL hard liquor/spirits, or 5 oz/100 mL wine) per week based on self-report. Participants must have a negative urine drug screen at screening.
15. The participant is taking any excluded medications or treatments.
16. If female, the participant is pregnant, lactating, or intending to become pregnant before, during, or within 4 weeks after participating in this study; or intending to donate ova during such time period.
17. The participant has a history or clinical manifestations of significant central nervous system, cardiovascular, pulmonary, hepatic, renal, metabolic, other gastrointestinal, urological, endocrine, or hematological disease that, in the opinion of the investigator, would confound the study results or compromise participant safety.
18. The participant requires hospitalization or has surgery scheduled during the course of the study or has undergone major surgical procedures within 30 days prior to the Screening Visit.
19. The participant has a history of malignancy (including MALToma) or has been treated for malignancy within 5 years prior to the start of the Screening Period (Visit 1). (The participant may be included in the study if he/she has cured cutaneous basal cell carcinoma or cervical carcinoma in situ).
20. The participant has acquired immunodeficiency syndrome or human immunodeficiency virus infection, or tests positive for the hepatitis B surface antigen, hepatitis C virus (HCV) antibody, or HCV RNA. However, participants who test positive for HCV antibody but negative for HCV RNA are permitted to participate.

21. The participant has any of the following abnormal laboratory test values at the start of the Screening Period:

    1. Creatinine levels: >2 mg/dL (>177 μmol/L)
    2. Alanine aminotransferase or aspartate aminotransferase >2 × the upper limit of normal (ULN) or total bilirubin >2 × ULN.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Healing Phase: Vonoprazan 20 mg; Participants will receive oral vonoprazan 20 mg once per day (QD) for a maximum of 8 weeks.	Drug: Vonoprazan; Over-encapsulated tablet administered orally with approximately 240 mL water, 30 minutes prior to the morning meal.
Active Comparator: Healing Phase: Lansoprazole 30 mg; Participants will receive oral lansoprazole 30 mg once per day (QD) for a maximum of 8 weeks.	Drug: Lansoprazole; Over-encapsulated capsule administered orally with approximately 240 mL water, 30 minutes prior to the morning meal.
Experimental: Maintenance Phase: Vonoprazan 10 mg; Participants will receive oral vonoprazan 10 mg once per day (QD) for a maximum of 24 weeks.	Drug: Vonoprazan; Over-encapsulated tablet administered orally with approximately 240 mL water, 30 minutes prior to the morning meal.
Experimental: Maintenance Phase: Vonoprazan 20 mg; Participants will receive oral vonoprazan 20 mg once per day (QD) for a maximum of 24 weeks.	Drug: Vonoprazan; Over-encapsulated tablet administered orally with approximately 240 mL water, 30 minutes prior to the morning meal.
Active Comparator: Maintenance Phase: Lansoprazole 15 mg; Participants will receive oral lansoprazole 15 mg once per day (QD) for a maximum of 24 weeks.	Drug: Lansoprazole; Over-encapsulated capsule administered orally with approximately 240 mL water, 30 minutes prior to the morning meal.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Healing Phase: Percentage of Participants Who Had Complete Healing of EE by Week 8	A participant was considered to have complete healing of EE if healing was demonstrated during endoscopy.	Week 8
Maintenance Phase: Percentage of Participants Who Maintained Complete Healing of EE at Week 24	A participant was considered to have complete healing of EE if healing was demonstrated during endoscopy.	Week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Healing Phase: Percentage of 24-hour Heartburn-free Days	A 24-hour heartburn-free day was defined as a day having no heartburn among all diary entries for that day. The percentage of 24-hour heartburn-free days was calculated using all days with at least 1 evening or morning diary entry during the treatment period of this phase.	Day 1 to Week 8
Healing Phase: Percentage of Participants With Baseline LA Classification Grades C or D Who Had Complete Healing of EE at Week 2	A participant was considered to have complete healing of EE if healing was demonstrated during endoscopy. LA Classification of Esophagitis Grading Scale: Grade C: One or more mucosal breaks that are continuous between the tops of 2 or more mucosal folds, which involves less than 75% of the circumference. Grade D: One or more mucosal breaks, which involves at least 75% of the circumference.	Week 2
Healing Phase: Percentage of Participants With Onset of Sustained Resolution of Heartburn by Day 3	Sustained resolution was defined as at least 7 consecutive days with no daytime or night time heartburn as assessed by the daily diary. A participant was considered to have sustained resolution of heartburn by Day 3 if the first day of the 7 consecutive days without symptoms was on Days 1, 2, or 3.	Day 1 to maximum of Day 10 (inclusive of 7 day heartburn assessment)
Healing Phase: Percentage of Participants With Baseline LA Classification Grades C or D Who Had Complete Healing of EE by Week 8	A participant was considered to have complete healing of EE if healing was demonstrated during endoscopy. LA Classification of Esophagitis Grading Scale: Grade C: One or more mucosal breaks that are continuous between the tops of 2 or more mucosal folds, which involves less than 75% of the circumference. Grade D: One or more mucosal breaks, which involves at least 75% of the circumference.	Week 8
Healing Phase: Percentage of Participants Who Had Complete Healing of EE at Week 2	A participant was considered to have complete healing of EE if healing was demonstrated during endoscopy.	Week 2
Maintenance Phase: Percentage of Participants With Baseline LA Classification Grades C or D Who Maintained Complete Healing of EE at Week 24	A participant was considered to have complete healing of EE if healing was demonstrated during endoscopy. LA Classification of Esophagitis Grading Scale: Grade C: One or more mucosal breaks that are continuous between the tops of 2 or more mucosal folds, which involves less than 75% of the circumference. Grade D: One or more mucosal breaks, which involves at least 75% of the circumference.	Week 24
Maintenance Phase: Percentage of 24-hour Heartburn-free Days	A 24-hour heartburn-free day was defined as a day having no heartburn among all diary entries for that day. The percentage of 24-hour heartburn-free days was calculated using all days with at least 1 evening or morning diary entry during the treatment period of this phase.	Day 1 to Week 24

Collaborators and Investigators

• Sponsor: Phathom Pharmaceuticals, Inc.
• Investigators: Study Director: Medical Director, Phathom Pharmaceuticals

Publications and helpful links

General Publications

• Laine L, DeVault K, Katz P, Mitev S, Lowe J, Hunt B, Spechler S. Vonoprazan Versus Lansoprazole for Healing and Maintenance of Healing of Erosive Esophagitis: A Randomized Trial. Gastroenterology. 2022 Oct 10:S0016-5085(22)01163-5. doi: 10.1053/j.gastro.2022.09.041. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Actual): October 28, 2019
• Primary Completion (Actual): July 29, 2021
• Study Completion (Actual): August 24, 2021

Study Registration Dates

• First Submitted: October 10, 2019
• First Submitted That Met QC Criteria: October 10, 2019
• First Posted (Actual): October 14, 2019

Study Record Updates

• Last Update Posted (Actual): July 29, 2022
• Last Update Submitted That Met QC Criteria: July 6, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Lansoprazole; Vonoprazan; Erosive Esophagitis
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Esophageal Diseases; Esophagitis; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Dexlansoprazole; Lansoprazole
• Other Study ID Numbers: EE-301; 2019-002579-33 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: Data from this study will be published; however, it is undecided if patient level data will be made available at this time.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No