Efficacy and Safety of Vonoprazan Compared to Lansoprazole in Participants With Erosive Esophagitis
NCT ID: NCT04124926
Last Updated: 2022-07-29
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1027 participants
INTERVENTIONAL
2019-10-28
2021-08-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Healing Phase: Vonoprazan 20 mg
Participants will receive oral vonoprazan 20 mg once per day (QD) for a maximum of 8 weeks.
Vonoprazan
Over-encapsulated tablet administered orally with approximately 240 mL water, 30 minutes prior to the morning meal.
Healing Phase: Lansoprazole 30 mg
Participants will receive oral lansoprazole 30 mg once per day (QD) for a maximum of 8 weeks.
Lansoprazole
Over-encapsulated capsule administered orally with approximately 240 mL water, 30 minutes prior to the morning meal.
Maintenance Phase: Vonoprazan 10 mg
Participants will receive oral vonoprazan 10 mg once per day (QD) for a maximum of 24 weeks.
Vonoprazan
Over-encapsulated tablet administered orally with approximately 240 mL water, 30 minutes prior to the morning meal.
Maintenance Phase: Vonoprazan 20 mg
Participants will receive oral vonoprazan 20 mg once per day (QD) for a maximum of 24 weeks.
Vonoprazan
Over-encapsulated tablet administered orally with approximately 240 mL water, 30 minutes prior to the morning meal.
Maintenance Phase: Lansoprazole 15 mg
Participants will receive oral lansoprazole 15 mg once per day (QD) for a maximum of 24 weeks.
Lansoprazole
Over-encapsulated capsule administered orally with approximately 240 mL water, 30 minutes prior to the morning meal.
Interventions
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Vonoprazan
Over-encapsulated tablet administered orally with approximately 240 mL water, 30 minutes prior to the morning meal.
Lansoprazole
Over-encapsulated capsule administered orally with approximately 240 mL water, 30 minutes prior to the morning meal.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Phathom Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Phathom Pharmaceuticals
Locations
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Pinnacle Research Group
Anniston, Alabama, United States
North Alabama Research Center LLC
Athens, Alabama, United States
Synexus Clinical Research US, Inc.
Birmingham, Alabama, United States
Medical Affiliated Research Center Inc
Huntsville, Alabama, United States
Synexus Clinical Research US, Inc. - East Valley Family Physicians, PLC
Chandler, Arizona, United States
Synexus Clinical Research US, Inc. - Central Arizona Medical Associates, PC
Mesa, Arizona, United States
Synexus Clinical Research US, Inc. - Desert Clinical Research, LLC
Mesa, Arizona, United States
Elite Clinical Studies - Phoenix - BTC - PPDS
Phoenix, Arizona, United States
Hope Research Institute LLC
Phoenix, Arizona, United States
Del Sol Research Management - BTC - PPDS
Tucson, Arizona, United States
Preferred Research Partners - ClinEdge - PPDS
Little Rock, Arkansas, United States
Applied Research Center of Little Rock
Little Rock, Arkansas, United States
Arkansas Gastroenterology
North Little Rock, Arkansas, United States
Atria Clinical Research - BTC - PPDS
North Little Rock, Arkansas, United States
Anaheim Clinical Trials LLC
Anaheim, California, United States
GW Research, Inc. - ClinEdge - PPDS
Chula Vista, California, United States
eStudySite - Chula Vista - PPDS
Chula Vista, California, United States
Kindred Medical Institute for Clinical Trials, LLC
Corona, California, United States
HB Clinical Trials, Inc.
Fountain Valley, California, United States
OM Research LLC
Lancaster, California, United States
Torrance Clinical Research Institute
Lomita, California, United States
LA County + USC Medical Center
Los Angeles, California, United States
Southern California Research Institute Medical Group, Inc.
Los Angeles, California, United States
Facey Medical Foundation
Mission Hills, California, United States
Palmtree Clinical Research
Palm Springs, California, United States
Precision Research Institute
San Diego, California, United States
Medical Associates Research Group, Inc.
San Diego, California, United States
Paragon Rx Clinical, Inc.
Santa Ana, California, United States
Synexus Clinical Research US, Inc. - Colorado Springs Family Practice
Colorado Springs, Colorado, United States
Western States Clinical Research, Inc.
Wheat Ridge, Colorado, United States
Gastroenterology Associates of Fairfield County
Bridgeport, Connecticut, United States
Connecticut Clinical Research Foundation
Bristol, Connecticut, United States
Riverside Clinical Research
Edgewater, Florida, United States
Research Centers of America - ERG
Hollywood, Florida, United States
Nature Coast Clinical Research
Inverness, Florida, United States
ENCORE Borland-Groover Clinical Research - ERN - PPDS
Jacksonville, Florida, United States
Columbus Clinical Services LLC
Miami, Florida, United States
Jesscan Medical Research
Miami, Florida, United States
Nuren Medical and Research Center
Miami, Florida, United States
Premier Research Associate, Inc.
Miami, Florida, United States
Gutierrez Medical Center
Orlando, Florida, United States
Advanced Gastroenterology Associates, LLC
Palm Harbor, Florida, United States
Innovation Medical Research Center
Palmetto Bay, Florida, United States
Synexus Clinical Research US, Inc. - St. Petersburg
Pinellas Park, Florida, United States
Precision Clinical Research, LLC
Sunrise, Florida, United States
Guardian Angel Research Center
Tampa, Florida, United States
Atlanta Gastroenterology Associates
Atlanta, Georgia, United States
Nexgen Research Center
Atlanta, Georgia, United States
Gastroenterology Associates of Central Georgia, LLC
Macon, Georgia, United States
In-Quest Medical Research, LLC
Peachtree Corners, Georgia, United States
Illinois Gastroenterology Group
Gurnee, Illinois, United States
Summit Digestive & Liver Disease Specialists State Street Clinic
Oakbrook Terrace, Illinois, United States
MediSphere Medical Research Center, LLC
Evansville, Indiana, United States
Gastroenterology Health Partners, PLLC
New Albany, Indiana, United States
Iowa Digestive Disease Center
Clive, Iowa, United States
Clinical Trials Management LLC
Covington, Louisiana, United States
CroNOLA, LLC.
Houma, Louisiana, United States
Clinical Trials Management LLC
Metairie, Louisiana, United States
Louisiana Research Center, LLC
Shreveport, Louisiana, United States
Meridian Clinical Research
Rockville, Maryland, United States
Clinical Associates Research
Towson, Maryland, United States
Oakland Medical Research Center
Troy, Michigan, United States
Gastroenterology Associates of Western Michigan, PLC
Wyoming, Michigan, United States
The Alliance for Multispecialty Research, LLC
Kansas City, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
Heartland Clinical Research, Inc
Omaha, Nebraska, United States
Synexus Clinical Research US, Inc. Site 1
Henderson, Nevada, United States
Synexus Clinical Research US, Inc. Site 2
Henderson, Nevada, United States
Sierra Clinical Research - ClinEdge - PPDS
Las Vegas, Nevada, United States
Site 2
Las Vegas, Nevada, United States
Las Vegas - Site 1
Las Vegas, Nevada, United States
Advanced Research Institute
Reno, Nevada, United States
Drug Trials America - ClinEdge
Hartsdale, New York, United States
Southtowns Gastroenterology, PLLC
Orchard Park, New York, United States
Carolinas Research Center
Charlotte, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Medication Management LLC
Greensboro, North Carolina, United States
Carolina Research
Greenville, North Carolina, United States
Peters Medical Research, LLC - ClinEdge - PPDS
High Point, North Carolina, United States
Carolina's GI Research, LLC
Raleigh, North Carolina, United States
Dayton Gastroenterology, Inc
Dayton, Ohio, United States
Prestige Clinical Research
Franklin, Ohio, United States
Central Sooner Research
Norman, Oklahoma, United States
Synexus Clinical Research US, Inc.
Anderson, South Carolina, United States
Clinical Trials of South Carolina
Charleston, South Carolina, United States
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, United States
Rapid City Medical Center LLP
Rapid City, South Dakota, United States
Multi Specialty Clinical Research
Johnson City, Tennessee, United States
Clinical Research Associates Inc
Nashville, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Inquest Clinical Research
Baytown, Texas, United States
Synexus Clinical Research US, Inc. - Dallas
Dallas, Texas, United States
Texas Tech University Health Sciences Center El Paso
El Paso, Texas, United States
Precision Research Institute, LLC
Houston, Texas, United States
Biopharma Informatic, LLC
Houston, Texas, United States
Rio Grande Gastroenterology
McAllen, Texas, United States
Digestive System Healthcare
Pasadena, Texas, United States
Pearland Physicians
Pearland, Texas, United States
Synexus Clinical Research US, Inc.
Plano, Texas, United States
Quality Research Inc
San Antonio, Texas, United States
Gastroenterology Research of San Antonio (GERSA)
San Antonio, Texas, United States
Southern Star Research Institute, LLC
San Antonio, Texas, United States
Synexus Clinical Research US, Inc.
Layton, Utah, United States
Advanced Research Institute
Ogden, Utah, United States
New River Valley Research Institute
Christiansburg, Virginia, United States
Verity Research, Inc.
Fairfax, Virginia, United States
Blue Ridge Medical Research
Lynchburg, Virginia, United States
Washington Gastroenterology
Bellevue, Washington, United States
Harborview Medical Center, University of Washington Medical Center
Seattle, Washington, United States
Fourth Multiprofile Hospital for Active Treatment
Sofia, Sofia-Grad, Bulgaria
Multiprofile Hospital for Active Treatment Puls AD - PPDS
Blagoevgrad, , Bulgaria
University Multiprofile Hospital for Active Treatment
Pleven, , Bulgaria
Second Multiprofile Hospital for Active Treatment Sofia
Sofia, , Bulgaria
Medical Center Excelsior OOD - PPDS
Sofia, , Bulgaria
Diagnostic-Consultative Center Aleksandrovska EOOD
Sofia, , Bulgaria
Synexus - Medical Center Synexus Sofia EOOD
Sofia, , Bulgaria
Synexus - Medical Centre Synexus Sofia EOOD
Stara Zagora, , Bulgaria
Nemocnice Pardubickeho kraje, a.s. Orlickoustecka nemocnice, Interni oddeleni, Cs.
Ústí nad Orlicí, Pardubice, Czechia
MEDIC KRAL s.r.o.
Prague, Prague, Czechia
PreventaMed s.r.o.
Olomouc, , Czechia
Synexus Czech s.r.o.
Prague, , Czechia
Krajska zdravotni, a.s. - Masarykova nemocnice v Usti nad Labem, o.z. Oddeleni gastroenterolgie
Ústí nad Labem, , Czechia
Debreceni Egyetem Klinikai Kozpont Nagyerdei Krt. 98, Belgyogyaszati Klinika
Debrecen, Hajdú-Bihar, Hungary
Synexus Affiliate BKS Research Kft. Hatvan
Hatvan, Heves County, Hungary
Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz
Nyíregyháza, Szabolcs-Szatmár-Bereg, Hungary
Synexus (DRS) - Synexus Magyarország Kft. Budapest
Budapest, , Hungary
Synexus Affiliate - Synexus Magyarorszag Kft. Debrecen
Debrecen, , Hungary
Synexus (DRS) - Synexus Magyarorszag Kft. Gyula
Gyula, , Hungary
Synexus (DRS) - Synexus Magyarország Kft. Zalaegerszeg
Zalaegerszeg, , Hungary
Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w Bydgoszczy Centrum Endoskopii Zabiegowej - Poradnia Chorob Jelitowych
Bydgoszcz, , Poland
Gabinet Lekarski-Janusz Rudzinski ul. Powstancow Warszawy 5
Bydgoszcz, , Poland
Synexus - Czestochowa
Częstochowa, , Poland
Synexus - Gdansk
Gdansk, , Poland
Synexus - Gdynia
Gdynia, , Poland
Synexus - Katowice
Katowice, , Poland
Synexus Affiliate - Krakowskie Centrum Medyczne
Krakow, , Poland
Centrum Opieki Zdrowotnej Orkan-Med Stec-Michalska Sp. J.
Ksawerów, , Poland
Synexus - Lodz
Lodz, , Poland
Santa Familia Centrum Badań Profilaktyki i Leczenia
Lodz, , Poland
GASTRO MED Zaklad Opieki Zdrowotnej
Lublin, , Poland
Synexus - Poznan
Poznan, , Poland
Korczowski Bartosz, Gabinet Lekarski
Rzeszów, , Poland
Twoja Przychodnia - Szczecińskie Centrum Medyczne
Szczecin, , Poland
Gastromed Specjalistyczne Centrum Gastrologii i Endoskopii
Torun, , Poland
REUMATIKA - Centrum Reumatologii NZOZ
Warsaw, , Poland
Synexus - Warszawa
Warsaw, , Poland
Synexus - Wroclaw
Wroclaw, , Poland
Melita Medical
Wroclaw, , Poland
Synexus Thames Valley Clinical Research Centre
Reading, Berkshire, United Kingdom
Synexus - Midlands Clinical Research Centre
Edgbaston, West Midlands, United Kingdom
Synexus - Wales Clinical Research Centre
Cardiff, , United Kingdom
Synexus - Lancashire Clinical Research Centre
Chorley, , United Kingdom
CPS Research
Glasgow, , United Kingdom
Synexus - Hexham Clinical Research Centre
Hexham, , United Kingdom
Synexus - Merseyside Clinical Research Centre
Liverpool, , United Kingdom
Synexus - Manchester Clinical Research Centre
Manchester, , United Kingdom
Synexus - North Tees Clinical Research Centre
Stockton-on-Tees, , United Kingdom
Countries
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References
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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. 2023 Jan;164(1):61-71. doi: 10.1053/j.gastro.2022.09.041. Epub 2022 Oct 10.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2019-002579-33
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
EE-301
Identifier Type: -
Identifier Source: org_study_id
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