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Non-Erosive Gastro-Esophageal Reflux DiseasePhase 3NCT05195528

A Study to Evaluate the Efficacy and Safety of Vonoprazan Compared to Placebo for Relief of Heartburn in Participants With Symptomatic Non-Erosive Gastroesophageal Reflux Disease (NERD)

A Phase 3 study testing Vonoprazan in people with Non-Erosive Gastro-Esophageal Reflux Disease and Heartburn, run by Phathom Pharmaceuticals, Inc. at 108 sites in United States.

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

The primary objectives of this study are to assess the efficacy of vonoprazan (10 mg and 20 mg once daily [QD]) compared to placebo (QD) in relief of heartburn over 4 weeks in participants with NERD. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Vonoprazan
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
776 participants
Where
108 sitesUnited States
Study dates
17 Jan 2022to 17 May 2023
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, including compliance with the electronic diary.
  • The participant signs and dates a written informed consent form (ICF) 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 subject has a diagnosis of symptomatic gastroesophageal reflux disease (GERD) with heartburn as the subject's predominant symptom prior to the Screening Period, as documented in the subject's medical record.
  • History of onset of heartburn at least 6 months prior to the Screening Period.
  • Heartburn reported on 4 or more days during any consecutive 7-day period of the Screening Period as recorded in the electronic diary.
  • A female participant of childbearing potential who is or may be sexually active with a non-sterilized 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 has endoscopically confirmed erosive esophagitis (EE) during the Screening Period. Endoscopy conducted during the Screening Period should be performed after participants meet Inclusion Criterion 6 (i.e., heartburn reported on 4 or more days during any consecutive 7-day period of the Screening Period as recorded in the electronic diary).
  • The participant has active irritable bowel syndrome (IBS) or has had a flare of IBS requiring therapy within the prior 6 months.
  • The participant has a history of or is suspected of having functional upper gastrointestinal disorders, such as:
  • Functional heartburn, as described in the Rome IV Criteria.
  • Functional dyspepsia, as described in the Rome IV Criteria.
  • The participant has endoscopic Barrett's esophagus (>1 cm of columnar-lined esophagus) and/or definite dysplastic changes in the esophagus.
Show all 27Show fewer
  • The participant has any other clinically significant 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) or hiatal hernia are eligible to participate.
  • The participant has scleroderma (systemic sclerosis) or systemic lupus erythematosus.
  • The participant has a history of surgery or endoscopic treatment affecting gastroesophageal reflux, including fundoplication and dilation for esophageal stricture (except dilation for a Schatzki's ring) or a history of gastric or duodenal surgery (except endoscopic removal of benign polyps).
  • The participant has an active gastric or duodenal ulcer within 4 weeks before the first dose of study drug.
  • The participant requires or is expected to require use of prescription or non-prescription proton pump inhibitors (PPIs) or histamine-2 receptor antagonists (H2RAs) throughout the study.
  • The participant has received any investigational compound (including those in post-marketing studies) within 30 days prior to the start of the Screening Period or vonoprazan in a clinical trial at any time (including participation in Study NERD-201). 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 had clinically significant upper or lower gastrointestinal bleeding within 4 weeks prior to the Screening Period.
  • 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, and titanium oxide, or red or yellow ferric oxide). 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 for cannabinoids/tetrahydrocannabinol (including prescription cannabinoids) and non-prescribed medications during the Screening Period.
  • The participant is taking any excluded medications or treatments listed in the protocol, including prescription cannabinoids/tetrahydrocannabinol.
  • 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 (from Visit 1 to end of Follow-up Period at Visit 10) or has undergone major surgical procedures within 30 days prior to the Screening Period.
  • The participant has a history of malignancy (including mucosa-associated lymphoid tissue lymphoma) 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-ribonucleic acid (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 (ALT) or aspartate aminotransferase (AST) >2 × the upper limit of normal (ULN) or total bilirubin >2 × ULN (except for participants with a diagnosis of Gilbert's syndrome).
  • The subject tests positive for active H pylori infection during the Screening Period, after ≥4 weeks free from antibiotics and bismuth and ≥2 weeks free from PPIs and histamine-2 receptor antagonists (H2RAs).

Trial locations and contacts

108 sites in 1 country.

108 sites in 1 country

United States108 sites

  • Investigative Clinical Research

    Annapolis, Maryland, 21401-1091

  • North Alabama Research Center LLC

    Athens, Alabama, 35611-2456

  • Washington Gastroenterology

    Bellevue, Washington, 98004-4631

  • Treasure Valley Medical Research

    Boise, Idaho, 83706-1345

  • Gastroenterology Associates of Fairfield County

    Bridgeport, Connecticut, 06606-5301

  • Connecticut Clinical Research Institute

    Bristol, Connecticut, 06010-5161

  • NY Scientific

    Brooklyn, New York, 11235

  • Gastroenterology Consultants of South Texas, PLLC

    Brownsville, Texas, 78550

  • Alliance Research Institute

    Canoga Park, California, 91304-3862

  • Digestive Health Associates of Texas, PA

    Carrollton, Texas, 75010-4545

  • Family Medicine Associates of Texas

    Carrollton, Texas, 75010

  • UNC Medical Center

    Chapel Hill, North Carolina, 27514-4220

  • Charlotte Gastroenterology and Hepatology PLLC

    Charlotte, North Carolina, 28207-1200

  • Digestive Health Specialists

    Chelmsford, Massachusetts, 01824-2775

  • Clinical Research Professionals

    Chesterfield, Missouri, 63005-1248

  • GW Research, Inc

    Chula Vista, California, 91910-3906

  • eStudy Site

    Chula Vista, California, 91911-6660

  • Gastro Health Research

    Cincinnati, Ohio, 45219

  • Iowa Digestive Disease Center

    Clive, Iowa, 50325-8151

  • Remington Davis Clinical Research

    Columbus, Ohio, 43215-7098

  • Gastro One

    Cordova, Tennessee, 38018

  • Kindred Medical Institute for Clinical Trials, LLC

    Corona, California, 92879-3124

  • Clinical Trials Management LLC

    Covington, Louisiana, 70433-4966

  • Cullman Research Center

    Cullman, Alabama, 35055

  • Southeast Clinical Research Center

    Dalton, Georgia, 30720

  • Atlanta Center For Gastroenterology PC

    Decatur, Georgia, 30033-6146

  • Velocity Clinical Research - Providence

    East Greenwich, Rhode Island, 02818-1762

  • Velocity Clinical Research - New Smyrna Beach

    Edgewater, Florida, 32132-2720

  • Texas Tech Physicians of El Paso

    El Paso, Texas, 79905-2707

  • BG Clinical Research

    Encinitas, California, 92024

  • The Gastroenterology Group of Northern NJ LLC

    Englewood, New Jersey, 07631-4141

  • Lillestol Research

    Fargo, North Dakota, 58104-4557

  • Allied Health Clinical Research Organization

    Freehold, New Jersey, 07728-2974

  • Paragon Rx Clinical

    Garden Grove, California, 92840-3103

  • Digestive Health Associates of Texas, P.A.dba DHAT Research Institute

    Garland, Texas, 75044-2210

  • Gastroenterology Associates, PA of Greenville

    Greenville, South Carolina, 29615

  • Medical Research Center of Connecticut, LLC

    Hamden, Connecticut, 06518

  • Susquehanna Research Group, LLC

    Harrisburg, Pennsylvania, 17110-3673

  • Drug Trials America

    Hartsdale, New York, 10530-1837

  • Peters Medical Research, LLC

    High Point, North Carolina, 27260

  • Galen Medical Group

    Hixson, Tennessee, 37343

  • Primecare Medical Group

    Houston, Texas, 77024-2593

  • Biopharma Informatic, LLC

    Houston, Texas, 77084

  • Medical Affiliated Research Center Inc

    Huntsville, Alabama, 35801-6002

  • Grand Teton Research Group, PLLC

    Idaho Falls, Idaho, 83404-7590

  • Nature Coast Clinical Research

    Inverness, Florida, 34452-4717

  • ENCORE Borland-Groover Clinical Research

    Jacksonville, Florida, 32256-6004

  • East Carolina Gastroenterology

    Jacksonville, North Carolina, 28546-7325

  • Combined Gastro Research

    Lafayette, Louisiana, 70503-2636

  • OM Research LLC

    Lancaster, California, 93534

  • Sierra Clinical Research

    Las Vegas, Nevada, 89106-4159

  • Office of Site 1

    Las Vegas, Nevada, 89119-5190

  • Office of Site 2

    Las Vegas, Nevada, 89128-0802

  • Preferred Research Partners - ClinEdge

    Little Rock, Arkansas, 72211-3868

  • Torrance Clinical Research Institute

    Lomita, California, 90717-2101

  • Blue Ridge Medical Research

    Lynchburg, Virginia, 24502-4272

  • Gastroenterology Associates of Central Georgia, LLC

    Macon, Georgia, 31201-3262

  • ClinCloud

    Maitland, Florida, 32751-5570

  • Tandem Clinical Research, LLC

    Marrero, Louisiana, 70072-3151

  • Rio Grande Gastroenterology

    McAllen, Texas, 78503

  • Great Lakes Medical Research LLC

    Mentor, Ohio, 44060-6211

  • MNGI Digestive Health

    Minneapolis, Minnesota, 55413

  • East View Medical Research, LLC

    Mobile, Alabama, 36606

  • Clinical Trials of America-NC, LLC

    Mount Airy, North Carolina, 27030-4459

  • Clinical Research Associates Inc

    Nashville, Tennessee, 37203-2066

  • QUALITY Medical Research

    Nashville, Tennessee, 37211-4981

  • Vanderbilt Digestive Disease Center

    Nashville, Tennessee, 37232-0028

  • Care Access Research

    New York, New York, 10065-8559

  • Arkansas Gastroenterology

    North Little Rock, Arkansas, 72117-2924

  • Legacy Clinical Solutions: Sensible HealthCare, LLC

    Ocoee, Florida, 34761-2964

  • Advanced Research Institute

    Ogden, Utah, 84405-4928

  • Quality Clinical Research - HyperCore

    Omaha, Nebraska, 68114-3723

  • Digestive Disease Consultants, PA

    Orange Park, Florida, 32073-4752

  • Medical Center

    Orlando, Florida, 32807-4346

  • Advanced Gastroenterology Associates, LLC

    Palm Harbor, Florida, 34684-2648

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104-5127

  • Elite Clinical Studies - Phoenix - Clinedge

    Phoenix, Arizona, 85018-5434

  • Minnesota Gastroenterology PA

    Plymouth, Minnesota, 55446-3661

  • Prospective Research Innovations

    Rancho Cucamonga, California, 91730

  • Advanced Research Institute

    Reno, Nevada, 89511-2060

  • Clinical Research Partners LLC

    Richmond, Virginia, 23226-3787

  • Atlanta Center For Clinical Research

    Roswell, Georgia, 30075-2456

  • Northern California Research Corp

    Sacramento, California, 95821-2640

  • Kalo Clinical Research

    Salt Lake City, Utah, 84102

  • Quality Research Inc

    San Antonio, Texas, 78209-1744

  • Gastroenterology Research of San Antonio (GERSA)

    San Antonio, Texas, 78229-3270

  • Southern Star Research Institute LLC

    San Antonio, Texas, 78229-4894

  • Digestive Care Center

    San Carlos, California, 94070-3939

  • Clinical Applications Laboratories Inc

    San Diego, California, 92103-5639

  • Medical Associates Research Group, Inc.

    San Diego, California, 92123-4207

  • Advanced Research Institute

    Sandy City, Utah, 84092-4350

  • Mount Vernon Clinical Research, LLC

    Sandy Springs, Georgia, 30328-4277

  • Paragon Rx Clinical, Inc.

    Santa Ana, California, 92703-1811

  • Sherman Clinical Research

    Sherman, Texas, 75092

  • Texas Digestive Disease Consultants

    Southlake, Texas, 76092-9167

  • GI Alliance

    Southlake, Texas, 76092

  • Precision Clinical Research

    Sunrise, Florida, 33351-7311

  • In Quest Medical Research

    Suwanee, Georgia, 30024-9134

  • Guardian Angel Research

    Tampa, Florida, 33614-2700

  • Texas Gastro Consultants

    Tomball, Texas, 77375-3348

  • Kansas Medical Clinic

    Topeka, Kansas, 66606-1707

  • Del Sol Research Management - Clinedge

    Tucson, Arizona, 85715-3834

  • Frontier Clinical Research, LLC

    Uniontown, Pennsylvania, 15401-9069

  • Clinical Trials of America, LLC

    West Monroe, Louisiana, 71291-5324

  • North Shore Gastroenterology

    Westlake, Ohio, 44145-7215

  • Western States Clinical Research Inc

    Wheat Ridge, Colorado, 80033-6800

  • Trial Management Associates LLC

    Wilmington, North Carolina, 28403-7018

  • Gastroenterology Associates of Western Michigan, PLC

    Wyoming, Michigan, 49519-9691

Other trials in United States

About this study

Official title: A Phase 3, Randomized, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of Vonoprazan 10 and 20 mg Compared to Placebo for Relief of Heartburn in Subjects With Symptomatic Non-Erosive Gastroesophageal Reflux Disease (NERD) After 4 Weeks and to Evaluate the Efficacy and Safety of Vonoprazan 10 and 20 mg for Relief of Heartburn in Subjects With NERD After 6 Months

The primary objectives of this study are to assess the efficacy of vonoprazan (10 mg and 20 mg once daily [QD]) compared to placebo (QD) in relief of heartburn over 4 weeks in participants with NERD.

Being tested
Vonoprazan, Placebo
Keywords
NERD, Vonoprazan
Medical subject headings
Heartburn

What participants receive

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

  • VonoprazanDrug

    Orally via capsule

  • PlaceboDrug

    Orally via capsule

Study groups in NCT05195528
Study groupRoleWhat they receive
Vonoprazan 10 mgExperimentalParticipants will be administered vonoprazan at a dose of 10 mg QD in the 4 week Placebo-controlled Treatment Period. Participants randomized to vonoprazan 10 mg in the Placebo-controlled Treatment Period will continue to take the same dose in the 20 week Extension Period.
Receives: Drug: Vonoprazan
Vonoprazan 20 mgExperimentalParticipants will be administered vonoprazan at a dose of 20 mg QD in the 4 week Placebo-controlled Treatment Period. Participants randomized to vonoprazan 20 mg in the Placebo-controlled Treatment Period will continue to take the same dose in the 20 week Extension Period.
Receives: Drug: Vonoprazan
PlaceboPlacebo comparatorParticipants will be administered the placebo QD in the 4 week Placebo-controlled Treatment Period. Participants randomized to placebo in the Placebo-controlled Treatment Period will be re-randomized to receive either vonoprazan 10 mg QD or vonoprazan 20 mg QD in the 20 week Extension Period.
Receives: Drug: Placebo

What is being measured

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

  1. Percentage of Days Without Daytime or Nighttime Heartburn

    Participants were assigned an electronic diary to complete twice daily, in the morning and evening. Diary day was considered heartburn-free if both morning and evening diary entries were heartburn-free and there was no reported use of rescue antacid, H2RAs, or PPIs.

    Measured: Day 1 to Day 28

Secondary outcomes (1)

  1. Percentage of Days Without Rescue Antacid Use

    Participants were assigned an electronic diary to complete twice daily, in the morning and evening. Participants recorded use of rescue antacid.

    Measured: Day 1 to Day 28

Timeline

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

  1. First posted19 Jan 2022
  2. Study start17 Jan 2022
  3. Primary completion21 Nov 2022
  4. Study completion17 May 2023

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
Double blind
Who is masked
Participant, Investigator
Enrolment
776 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05195528
Sponsor's protocol ID
NERD-301
Status last verified
Dec 2023
First submitted
4 Jan 2022
Last updated
29 Dec 2023
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Antunes C, Ghosh G, Katz P, Yadlapati R, Leifke E, Harris T, Graham H, Laine L. Vonoprazan Improves Nocturnal Gastroesophageal Reflux Symptoms in Nonerosive Reflux Disease. Am J Gastroenterol. 2026 Aug 1;121(8):1866-1874. doi: 10.14309/ajg.0000000000003794. Epub 2025 Oct 13.

    PubMed 41081570

  • Laine L, Spechler S, Yadlapati R, Schnoll-Sussman F, Smith N, Leifke E, Harris T, Hunt B, Fass R, Katz P. Vonoprazan is Efficacious for Treatment of Heartburn in Non-erosive Reflux Disease: A Randomized Trial. Clin Gastroenterol Hepatol. 2024 Nov;22(11):2211-2220.e10. doi: 10.1016/j.cgh.2024.05.004. Epub 2024 May 14.

    PubMed 38750866

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Vonoprazan in people with Non-Erosive Gastro-Esophageal Reflux Disease and Heartburn, run by Phathom Pharmaceuticals, Inc. at 108 sites in United States.

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 7 inclusion and 27 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 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 108 sites in United States. 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. Some participants in this study may receive a placebo. 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 Dec 2023). 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?

Percentage of Days Without Daytime or Nighttime Heartburn (time frame: Day 1 to Day 28). 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 NCT05195528, which also lists 2 linked publications.

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 Dec 2023.

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