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AzTrials

Erosive EsophagitisPhase 3NCT04124926

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

A Phase 3 study testing Vonoprazan and Lansoprazole in people with Erosive Esophagitis, run by Phathom Pharmaceuticals, Inc. at 157 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

To evaluate the efficacy and safety of vonoprazan compared to lansoprazole in participants with erosive esophagitis. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Erosive Esophagitis
What is being tested?
Vonoprazan and Lansoprazole
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,027 participants
Where
157 sitesin 6 countries
Study dates
28 Oct 2019to 24 Aug 2021
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The participant is ≥18 years of age at the time of informed consent signing.
  • In the opinion of the investigator or subinvestigators, the participant is capable of understanding and complying with protocol requirements.
  • 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.
  • 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.
  • 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.

Who cannot join

  • 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.
  • The participant is determined to be positive for Helicobacter pylori (HP) or has had an HP infection within 45 days of randomization.
  • The participant has endoscopic Barrett's esophagus (>1 cm of columnar-lined esophagus) and/or definite dysplastic changes in the esophagus.
  • 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.
  • The participant has scleroderma (systemic sclerosis).
  • 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).
Show all 23Show fewer
  • 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.
  • 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.
  • 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.
  • The participant has cutaneous lupus erythematosus or systemic lupus erythematosus.
  • The participant has had clinically significant upper or lower gastrointestinal bleeding within 4 weeks prior to randomization.
  • The participant has Zollinger-Ellison syndrome or other gastric acid hypersecretory conditions.
  • 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.
  • 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.
  • The participant is taking any excluded medications or treatments.
  • 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.
  • 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.
  • 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.
  • 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).
  • 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.
  • The participant has any of the following abnormal laboratory test values at the start of the Screening Period:
  • Creatinine levels: >2 mg/dL (>177 μmol/L)
  • Alanine aminotransferase or aspartate aminotransferase >2 × the upper limit of normal (ULN) or total bilirubin >2 × ULN.

Trial locations and contacts

157 sites in 6 countries.

157 sites in 6 countries

United States109 sites

  • Anaheim Clinical Trials LLC

    Anaheim, California, 92801

  • Synexus Clinical Research US, Inc.

    Anderson, South Carolina, 29621

  • Pinnacle Research Group

    Anniston, Alabama, 36207

  • North Alabama Research Center LLC

    Athens, Alabama, 35611

  • Atlanta Gastroenterology Associates

    Atlanta, Georgia, 30342

  • Nexgen Research Center

    Atlanta, Georgia, 30345

  • Inquest Clinical Research

    Baytown, Texas, 77521

  • Washington Gastroenterology

    Bellevue, Washington, 98004

  • Synexus Clinical Research US, Inc.

    Birmingham, Alabama, 35211

  • Gastroenterology Associates of Fairfield County

    Bridgeport, Connecticut, 06606

  • Connecticut Clinical Research Foundation

    Bristol, Connecticut, 06010

  • Synexus Clinical Research US, Inc. - East Valley Family Physicians, PLC

    Chandler, Arizona, 85224

  • Clinical Trials of South Carolina

    Charleston, South Carolina, 29406

  • Carolinas Research Center

    Charlotte, North Carolina, 28215

  • New River Valley Research Institute

    Christiansburg, Virginia, 24073

  • GW Research, Inc. - ClinEdge - PPDS

    Chula Vista, California, 91910

  • eStudySite - Chula Vista - PPDS

    Chula Vista, California, 91911

  • Iowa Digestive Disease Center

    Clive, Iowa, 50325

  • Synexus Clinical Research US, Inc. - Colorado Springs Family Practice

    Colorado Springs, Colorado, 80909

  • Kindred Medical Institute for Clinical Trials, LLC

    Corona, California, 92879

  • Clinical Trials Management LLC

    Covington, Louisiana, 70433

  • Synexus Clinical Research US, Inc. - Dallas

    Dallas, Texas, 75234

  • Dayton Gastroenterology, Inc

    Dayton, Ohio, 45415

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Riverside Clinical Research

    Edgewater, Florida, 32132

  • Texas Tech University Health Sciences Center El Paso

    El Paso, Texas, 79905

  • MediSphere Medical Research Center, LLC

    Evansville, Indiana, 47714

  • Verity Research, Inc.

    Fairfax, Virginia, 22031

  • HB Clinical Trials, Inc.

    Fountain Valley, California, 92708-7510

  • Prestige Clinical Research

    Franklin, Ohio, 45005

  • Medication Management LLC

    Greensboro, North Carolina, 27408

  • Carolina Research

    Greenville, North Carolina, 27834

  • Illinois Gastroenterology Group

    Gurnee, Illinois, 60031

  • Drug Trials America - ClinEdge

    Hartsdale, New York, 10530

  • Synexus Clinical Research US, Inc. Site 1

    Henderson, Nevada, 89052

  • Synexus Clinical Research US, Inc. Site 2

    Henderson, Nevada, 89052

  • Peters Medical Research, LLC - ClinEdge - PPDS

    High Point, North Carolina, 27262

  • Research Centers of America - ERG

    Hollywood, Florida, 33024

  • CroNOLA, LLC.

    Houma, Louisiana, 70360

  • Precision Research Institute, LLC

    Houston, Texas, 77036

  • Biopharma Informatic, LLC

    Houston, Texas, 77084

  • Medical Affiliated Research Center Inc

    Huntsville, Alabama, 35801

  • Nature Coast Clinical Research

    Inverness, Florida, 34452

  • ENCORE Borland-Groover Clinical Research - ERN - PPDS

    Jacksonville, Florida, 32256

  • Multi Specialty Clinical Research

    Johnson City, Tennessee, 37601

  • The Alliance for Multispecialty Research, LLC

    Kansas City, Missouri, 64114

  • OM Research LLC

    Lancaster, California, 93534

  • Sierra Clinical Research - ClinEdge - PPDS

    Las Vegas, Nevada, 89106

  • Site 2

    Las Vegas, Nevada, 89119

  • Las Vegas - Site 1

    Las Vegas, Nevada, 89128

  • Synexus Clinical Research US, Inc.

    Layton, Utah, 84041

  • Preferred Research Partners - ClinEdge - PPDS

    Little Rock, Arkansas, 72211

  • Applied Research Center of Little Rock

    Little Rock, Arkansas, 72212

  • Torrance Clinical Research Institute

    Lomita, California, 90717

  • LA County + USC Medical Center

    Los Angeles, California, 90033

  • Southern California Research Institute Medical Group, Inc.

    Los Angeles, California, 90045

  • Blue Ridge Medical Research

    Lynchburg, Virginia, 24502

  • Gastroenterology Associates of Central Georgia, LLC

    Macon, Georgia, 31201

  • Rio Grande Gastroenterology

    McAllen, Texas, 78503

  • Synexus Clinical Research US, Inc. - Central Arizona Medical Associates, PC

    Mesa, Arizona, 85206

  • Synexus Clinical Research US, Inc. - Desert Clinical Research, LLC

    Mesa, Arizona, 85213

  • Clinical Trials Management LLC

    Metairie, Louisiana, 70006

  • Columbus Clinical Services LLC

    Miami, Florida, 33125

  • Jesscan Medical Research

    Miami, Florida, 33134

  • Nuren Medical and Research Center

    Miami, Florida, 33144

  • Premier Research Associate, Inc.

    Miami, Florida, 33165

  • Facey Medical Foundation

    Mission Hills, California, 91345

  • Coastal Carolina Research Center

    Mt. Pleasant, South Carolina, 29464

  • Clinical Research Associates Inc

    Nashville, Tennessee, 37203

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37212

  • Gastroenterology Health Partners, PLLC

    New Albany, Indiana, 47150

  • Central Sooner Research

    Norman, Oklahoma, 73071

  • Arkansas Gastroenterology

    North Little Rock, Arkansas, 72117

  • Atria Clinical Research - BTC - PPDS

    North Little Rock, Arkansas, 72117

  • Summit Digestive & Liver Disease Specialists State Street Clinic

    Oakbrook Terrace, Illinois, 60181

  • Advanced Research Institute

    Ogden, Utah, 84405

  • Heartland Clinical Research, Inc

    Omaha, Nebraska, 68134

  • Southtowns Gastroenterology, PLLC

    Orchard Park, New York, 14127

  • Gutierrez Medical Center

    Orlando, Florida, 32807

  • Advanced Gastroenterology Associates, LLC

    Palm Harbor, Florida, 34684

  • Palmtree Clinical Research

    Palm Springs, California, 92262

  • Innovation Medical Research Center

    Palmetto Bay, Florida, 33157

  • Digestive System Healthcare

    Pasadena, Texas, 77505

  • In-Quest Medical Research, LLC

    Peachtree Corners, Georgia, 30071

  • Pearland Physicians

    Pearland, Texas, 77581

  • Elite Clinical Studies - Phoenix - BTC - PPDS

    Phoenix, Arizona, 85018

  • Hope Research Institute LLC

    Phoenix, Arizona, 85018

  • Synexus Clinical Research US, Inc. - St. Petersburg

    Pinellas Park, Florida, 33781

  • Synexus Clinical Research US, Inc.

    Plano, Texas, 75093

  • Carolina's GI Research, LLC

    Raleigh, North Carolina, 27607

  • Rapid City Medical Center LLP

    Rapid City, South Dakota, 57701

  • Advanced Research Institute

    Reno, Nevada, 89511

  • Meridian Clinical Research

    Rockville, Maryland, 20854

  • Quality Research Inc

    San Antonio, Texas, 78209

  • Gastroenterology Research of San Antonio (GERSA)

    San Antonio, Texas, 78229

  • Southern Star Research Institute, LLC

    San Antonio, Texas, 78229

  • Precision Research Institute

    San Diego, California, 92114

  • Medical Associates Research Group, Inc.

    San Diego, California, 92123

  • Paragon Rx Clinical, Inc.

    Santa Ana, California, 92703

  • Harborview Medical Center, University of Washington Medical Center

    Seattle, Washington, 98104

  • Louisiana Research Center, LLC

    Shreveport, Louisiana, 71105

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Precision Clinical Research, LLC

    Sunrise, Florida, 33351

  • Guardian Angel Research Center

    Tampa, Florida, 33614

  • Clinical Associates Research

    Towson, Maryland, 21286

  • Oakland Medical Research Center

    Troy, Michigan, 48085

  • Del Sol Research Management - BTC - PPDS

    Tucson, Arizona, 85712

  • Western States Clinical Research, Inc.

    Wheat Ridge, Colorado, 80033

  • Gastroenterology Associates of Western Michigan, PLC

    Wyoming, Michigan, 49519

Other trials in United States

Poland19 sites

  • Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w Bydgoszczy Centrum Endoskopii Zabiegowej - Poradnia Chorob Jelitowych

    Bydgoszcz, 85-168

  • Gabinet Lekarski-Janusz Rudzinski ul. Powstancow Warszawy 5

    Bydgoszcz, 85-681

  • Synexus - Czestochowa

    Częstochowa, 42-202

  • Synexus - Gdansk

    Gdansk, 80-382

  • Synexus - Gdynia

    Gdynia, 81-537

  • Synexus - Katowice

    Katowice, 40-040

  • Synexus Affiliate - Krakowskie Centrum Medyczne

    Krakow, 31-501

  • Centrum Opieki Zdrowotnej Orkan-Med Stec-Michalska Sp. J.

    Ksawerów, 95-054

  • Synexus - Lodz

    Lodz, 90-127

  • Santa Familia Centrum Badań Profilaktyki i Leczenia

    Lodz, 90-302

  • GASTRO MED Zaklad Opieki Zdrowotnej

    Lublin, 20-582

  • Synexus - Poznan

    Poznan, 60-702

  • Korczowski Bartosz, Gabinet Lekarski

    Rzeszów, 35-302

  • Twoja Przychodnia - Szczecińskie Centrum Medyczne

    Szczecin, 71-434

  • Gastromed Specjalistyczne Centrum Gastrologii i Endoskopii

    Torun, 87-100

  • REUMATIKA - Centrum Reumatologii NZOZ

    Warsaw, 0-691

  • Synexus - Warszawa

    Warsaw, 01-192

  • Synexus - Wroclaw

    Wroclaw, 50-381

  • Melita Medical

    Wroclaw, 50-449

Other trials in Poland

United Kingdom9 sites

  • Synexus - Wales Clinical Research Centre

    Cardiff, CF15 9SS

  • Synexus - Lancashire Clinical Research Centre

    Chorley, PR7 7NA

  • Synexus - Midlands Clinical Research Centre

    Edgbaston, West Midlands, B15 2SQ

  • CPS Research

    Glasgow, G20 0XA

  • Synexus - Hexham Clinical Research Centre

    Hexham, NE46 1QJ

  • Synexus - Merseyside Clinical Research Centre

    Liverpool, L22 0LG

  • Synexus - Manchester Clinical Research Centre

    Manchester, M15 6SE

  • Synexus Thames Valley Clinical Research Centre

    Reading, Berkshire, RG2 0TG

  • Synexus - North Tees Clinical Research Centre

    Stockton-on-Tees, TS19 8PE

Other trials in United Kingdom

Bulgaria8 sites

  • Multiprofile Hospital for Active Treatment Puls AD - PPDS

    Blagoevgrad, 2700

  • University Multiprofile Hospital for Active Treatment

    Pleven, 5800

  • Fourth Multiprofile Hospital for Active Treatment

    Sofia, Sofia-Grad, 1606

  • Second Multiprofile Hospital for Active Treatment Sofia

    Sofia, 1202

  • Medical Center Excelsior OOD - PPDS

    Sofia, 1407

  • Diagnostic-Consultative Center Aleksandrovska EOOD

    Sofia, 1431

  • Synexus - Medical Center Synexus Sofia EOOD

    Sofia, 1784

  • Synexus - Medical Centre Synexus Sofia EOOD

    Stara Zagora, 6003

Other trials in Bulgaria

Hungary7 sites

  • Synexus (DRS) - Synexus Magyarország Kft. Budapest

    Budapest, 1036

  • Debreceni Egyetem Klinikai Kozpont Nagyerdei Krt. 98, Belgyogyaszati Klinika

    Debrecen, Hajdú-Bihar, 4032

  • Synexus Affiliate - Synexus Magyarorszag Kft. Debrecen

    Debrecen, 4025

  • Synexus (DRS) - Synexus Magyarorszag Kft. Gyula

    Gyula, 5700

  • Synexus Affiliate BKS Research Kft. Hatvan

    Hatvan, Heves County, 3000

  • Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz

    Nyíregyháza, Szabolcs-Szatmár-Bereg, 4400

  • Synexus (DRS) - Synexus Magyarország Kft. Zalaegerszeg

    Zalaegerszeg, 8900

Other trials in Hungary

Czechia5 sites

  • PreventaMed s.r.o.

    Olomouc, 779 00

  • MEDIC KRAL s.r.o.

    Prague, Prague, 190 00

  • Synexus Czech s.r.o.

    Prague, 120 00

  • Krajska zdravotni, a.s. - Masarykova nemocnice v Usti nad Labem, o.z. Oddeleni gastroenterolgie

    Ústí nad Labem, 401 13

  • Nemocnice Pardubickeho kraje, a.s. Orlickoustecka nemocnice, Interni oddeleni, Cs.

    Ústí nad Orlicí, Pardubice, 562 18

Other trials in Czechia

About this study

Official title: 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.

Being tested
Vonoprazan, Lansoprazole
Keywords
Erosive Esophagitis, Vonoprazan, Lansoprazole

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VonoprazanDrug

    Over-encapsulated tablet administered orally with approximately 240 mL water, 30 minutes prior to the morning meal.

  • LansoprazoleDrug

    Over-encapsulated capsule administered orally with approximately 240 mL water, 30 minutes prior to the morning meal.

Study groups in NCT04124926
Study groupRoleWhat they receive
Healing Phase: Vonoprazan 20 mgExperimentalParticipants will receive oral vonoprazan 20 mg once per day (QD) for a maximum of 8 weeks.
Receives: Drug: Vonoprazan
Healing Phase: Lansoprazole 30 mgActive comparatorParticipants will receive oral lansoprazole 30 mg once per day (QD) for a maximum of 8 weeks.
Receives: Drug: Lansoprazole
Maintenance Phase: Vonoprazan 10 mgExperimentalParticipants will receive oral vonoprazan 10 mg once per day (QD) for a maximum of 24 weeks.
Receives: Drug: Vonoprazan
Maintenance Phase: Vonoprazan 20 mgExperimentalParticipants will receive oral vonoprazan 20 mg once per day (QD) for a maximum of 24 weeks.
Receives: Drug: Vonoprazan
Maintenance Phase: Lansoprazole 15 mgActive comparatorParticipants will receive oral lansoprazole 15 mg once per day (QD) for a maximum of 24 weeks.
Receives: Drug: Lansoprazole

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Week 8

  2. 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.

    Measured: Week 24

Secondary outcomes (7)

  1. 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.

    Measured: Day 1 to Week 8

  2. 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.

    Measured: Week 2

  3. 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.

    Measured: Day 1 to maximum of Day 10 (inclusive of 7 day heartburn assessment)

  4. 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.

    Measured: Week 8

  5. 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.

    Measured: Week 2

  6. 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.

    Measured: Week 24

  7. 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.

    Measured: Day 1 to Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Oct 2019
  2. Study start28 Oct 2019
  3. Primary completion29 Jul 2021
  4. Study completion24 Aug 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,027 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04124926
Sponsor's protocol ID
EE-301
Other IDs
2019-002579-33, 2019
Status last verified
Jul 2022
First submitted
10 Oct 2019
Last updated
29 Jul 2022
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided: Data from this study will be published; however, it is undecided if patient level data will be made available at this time.

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. 2023 Jan;164(1):61-71. doi: 10.1053/j.gastro.2022.09.041. Epub 2022 Oct 10.

    PubMed 36228734

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Vonoprazan and Lansoprazole in people with Erosive Esophagitis, run by Phathom Pharmaceuticals, Inc. at 157 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 157 sites in United States, Poland, United Kingdom, Bulgaria, Hungary and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Jul 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Healing Phase: Percentage of Participants Who Had Complete Healing of EE by Week 8 (time frame: Week 8). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04124926, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2022.

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