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Non-Erosive Gastro-Esophageal Reflux DiseasePhase 2NCT04799158

A Study to Evaluate the Efficacy and Safety of Vonoprazan Compared to Placebo in Participants With Symptomatic Non-Erosive Gastroesophageal Reflux Disease

A Phase 2 study testing Vonoprazan in people with Non-Erosive Gastro-Esophageal Reflux Disease and Heartburn, run by Phathom Pharmaceuticals, Inc. at 63 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, 20 mg, and 40 mg On-Demand) compared to placebo (On-Demand) in relief of episodic heartburn over 6 weeks in participants with symptomatic non-erosive gastroesophageal reflux disease (NERD), and to assess the safety of vonoprazan (10… 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
458 participants
Where
63 sitesUnited States
Study dates
25 Mar 2021to 17 Jan 2022
Phase
Phase 2
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 sub investigators, the participant is capable of understanding and complying with protocol requirements.
  • 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 participant identified their main symptom as heartburn, a burning sensation in the retrosternal area (behind the breastbone).
  • History of episodes of heartburn for 6 months or longer prior to screening.
  • Heartburn reported on 4 or more days during any 7 consecutive days in the Screening Period as recorded in the electronic diary.
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  • 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.
  • The participant completes the Run-In Period, during which the participant was at least 80% compliant with open-label study drug.
  • The participant has stable disease, ie, no heartburn the last 7 days of the Run-In Period.
  • The participant continues to fulfill all eligibility criteria for the Run-In Period (except Inclusion Criteria 4).
  • Participant completes at least 80% of diary entries during Run-In Period, including 80% of diary entries over the last 7 days.

Who cannot join

  • Endoscopically confirmed erosive esophagitis (EE) during the Screening Period assessed by the investigator. Endoscopy should be performed after participants meet Inclusion Criteria 6. Any endoscopic confirmation performed in a routine clinical setting within 7 days before signing the informed consent is acceptable to use for the purpose of fulfilling the screening requirement.
  • The participant has active irritable bowel syndrome (IBS) or had a flare of IBS requiring therapy within the prior 6 months.
  • The participant has a history of or is suspected of having functional heartburn diagnosed by the Rome IV criteria.
  • The participant has a history of or is suspected of having functional dyspepsia diagnosed by 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.
  • 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.
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  • 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).
  • The participant has an active gastric or duodenal ulcer within 4 weeks before the first dose of study drug.
  • Use of prescription or non-prescription proton pump inhibitors (PPIs) or histamine-2 receptor antagonists (H2RAs) throughout the study.
  • The participant has received vonoprazan in a clinical trial at any time or any other 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 screening.
  • 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). Skin testing may be performed according to local standard practice to confirm hypersensitivity.
  • The participant has a history of alcohol abuse, illegal drug use, drug addiction, 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 within the 12 months prior to screening. Participants must have a negative urine drug screen for cannabinoids/ tetrahydrocannabinol and nonprescribed medications at screening. Participants taking prescription drugs (except prescription cannabinoids/tetrahydrocannabinol) will be allowed.
  • The participant is taking any excluded medications or treatments listed in the protocol.
  • 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 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 recovered from cutaneous basal cell carcinoma or cervical carcinoma in situ).
  • The participant has acquired immune deficiency syndrome (AIDS) or human immunodeficiency virus (HIV) infection, or tests positive for the hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or HCV ribonucleic acid (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 (ALT) or aspartate aminotransferase (AST) >2 × the upper limit of normal (ULN) or total bilirubin >2 × ULN (except participants with Gilbert Syndrome)

Trial locations and contacts

63 sites in 1 country.

63 sites in 1 country

United States63 sites

  • Investigative Clinical Research

    Annapolis, Maryland, 21401-1091

  • Pinnacle Research Group

    Anniston, Alabama, 36207

  • North Alabama Research Center LLC

    Athens, Alabama, 35611-2456

  • Inquest Clinical Research

    Baytown, Texas, 77521-2416

  • Treasure Valley Medical Research

    Boise, Idaho, 83706-1345

  • Imagine Research of Palm Beach County

    Boynton Beach, Florida, 33435-5610

  • Family Medicine Associates of Texas

    Carrollton, Texas, 75010

  • Javara Inc

    Charlotte, North Carolina, 28287-3884

  • Care Access

    Chicago, Illinois, 60616

  • GW Research, Inc

    Chula Vista, California, 91910-3906

  • eStudySite

    Chula Vista, California, 91911-6660

  • Iowa Digestive Disease Center

    Clive, Iowa, 50325-8151

  • IACT Health

    Columbus, Georgia, 31904-8946

  • Remington Davis Inc

    Columbus, Ohio, 43215-7098

  • Clinical Trials Management LLC

    Covington, Louisiana, 70433-4966

  • Riverside Clinical Research

    Edgewater, Florida, 32132

  • GI Associates and Endoscopy Center

    Flowood, Mississippi, 39232

  • Paragon Rx Clinical

    Garden Grove, California, 92840-3103

  • Medication Management LLC

    Greensboro, North Carolina, 27408-7099

  • Carolina Research

    Greenville, North Carolina, 27834-3761

  • Drug Trials America

    Hartsdale, New York, 10530-1837

  • Peters Medical Research, LLC

    High Point, North Carolina, 27262-4800

  • Synergy Group US, LLC

    Houston, Texas, 77036

  • Biopharma Informatic, LLC

    Houston, Texas, 77084

  • Medical Affiliated Research Center Inc

    Huntsville, Alabama, 35801

  • Nature Coast Clinical Research

    Inverness, Florida, 34452-4717

  • ENCORE Borland-Groover Clinical Research

    Jacksonville, Florida, 32256-6004

  • OM Research LLC

    Lancaster, California, 93534-5504

  • Sierra Clinical Research - ClinEdge

    Las Vegas, Nevada, 89106-4159

  • Site 2

    Las Vegas, Nevada, 89119

  • Site 1

    Las Vegas, Nevada, 89128

  • Preferred Research Partners - ClinEdge

    Little Rock, Arkansas, 72211-3868

  • ClinCloud

    Maitland, Florida, 32751-3320

  • Legacy Clinical Solutions: Tandem Clinical Research, LLC

    Marrero, Louisiana, 70072-3156

  • Rio Grande Gastroenterology

    McAllen, Texas, 78530

  • Clinical Trials Management LLC

    Metairie, Louisiana, 70006-4165

  • Clinical Research Associates Inc

    Nashville, Tennessee, 37203-2066

  • Coastal Carolina Research Center

    North Charleston, South Carolina, 29405

  • Arkansas Gastroenterology

    North Little Rock, Arkansas, 72117-2924

  • Advanced Research Institute

    Ogden, Utah, 84405

  • Quality Clinical Research

    Omaha, Nebraska, 68114

  • G. Medical Center

    Orlando, Florida, 32807-4346

  • Advanced Gastroenterology Associates, LLC

    Palm Harbor, Florida, 34684

  • Elite Clinical Studies, LLC

    Phoenix, Arizona, 85018

  • Clinical Research Center of Florida

    Pompano Beach, Florida, 33060-6934

  • Rapid City Medical Center LLP

    Rapid City, South Dakota, 57701-5462

  • Advanced Research Institute

    Reno, Nevada, 89511

  • Quality Research Inc

    San Antonio, Texas, 78209-1744

  • Gastroenterology Research of San Antonio (GERSA)

    San Antonio, Texas, 78229-3270

  • Medical Associates Research Group, Inc.

    San Diego, California, 92123-4207

  • Advanced Research Institute

    Sandy City, Utah, 84092-4350

  • Paragon Rx Clinical, Inc.

    Santa Ana, California, 92703-1811

  • Sherman Clinical Research

    Sherman, Texas, 75092

  • Virginia Gastroenterology Institute

    Suffolk, Virginia, 23435

  • Precision Clinical Research, LLC

    Sunrise, Florida, 33351-7311

  • In Quest Medical Research

    Suwanee, Georgia, 30024-9134

  • Guardian Angel Research Center

    Tampa, Florida, 33614

  • Del Sol Research Management - Clinedge

    Tucson, Arizona, 85712-5637

  • Frontier Clinical Research, LLC

    Uniontown, Pennsylvania, 15401-9069

  • 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

  • Florida Medical Clinic, LLC Clinical Research Division

    Zephyrhills, Florida, 33542

Other trials in United States

About this study

Official title: A Phase 2, Randomized, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of Vonoprazan 10 mg, 20 mg, and 40 mg Compared to Placebo for Relief of Episodic Heartburn in Subjects With Symptomatic Non-Erosive Gastroesophageal Reflux Disease

The primary objectives of this study are to assess the efficacy of vonoprazan (10 mg, 20 mg, and 40 mg On-Demand) compared to placebo (On-Demand) in relief of episodic heartburn over 6 weeks in participants with symptomatic non-erosive gastroesophageal reflux disease (NERD), and to assess the safety of vonoprazan (10 mg, 20 mg, and 40 mg On-Demand) compared to placebo (On-Demand) in participants with symptomatic NERD.

Being tested
Vonoprazan, Placebo
Keywords
Symptomatic Non-Erosive Gastroesophageal Reflux Disease, NERD, Vonoprazan, Heartburn
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 capsules

  • PlaceboDrug

    Orally via capsules

Study groups in NCT04799158
Study groupRoleWhat they receive
Run-In PeriodExperimentalParticipants will receive vonoprazan 20 mg once daily for up to 4 weeks.
Receives: Drug: Vonoprazan
Vonoprazan 10 mg: On-Demand Treatment PeriodExperimentalParticipants who have stable disease (no heartburn on the last 7 days of the Run-In Period) will take vonoprazan 10 mg when heartburn occurs during the 6 week On-Demand Treatment Period. Participants can take no more than one dose in a 24 hour period.
Receives: Drug: Vonoprazan
Vonoprazan 20 mg: On-Demand Treatment PeriodExperimentalParticipants who have stable disease (no heartburn on the last 7 days of the Run-In Period) will take vonoprazan 20 mg when heartburn occurs during the 6 week On-Demand Treatment Period. Participants can take no more than one dose in a 24 hour period.
Receives: Drug: Vonoprazan
Vonoprazan 40 mg: On-Demand Treatment PeriodExperimentalParticipants who have stable disease (no heartburn on the last 7 days of the Run-In Period) will take vonoprazan 40 mg when heartburn occurs during the 6 week On-Demand Treatment Period. Participants can take no more than one dose in a 24 hour period.
Receives: Drug: Vonoprazan
Placebo: On-Demand Treatment PeriodPlacebo comparatorParticipants who have stable disease (no heartburn on the last 7 days of the Run-In Period) will take a placebo when heartburn occurs during the 6 week On-Demand Treatment Period. Participants can take no more than one dose in a 24 hour period.
Receives: Drug: Placebo

What is being measured

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

  1. Percentage of Evaluable Heartburn Episodes Completely Relieved Within 3 Hours and With No Further Heartburn Reported for 24 Hours After Taking Study Drug

    An evaluable heartburn episode was an episode for which study drug was taken and for which the participant completed at least one entry in the heartburn episode diary.

    For a heartburn episode to be considered completely relieved, a participant must not have taken rescue antacid within 3 hours of taking study drug. For sustained relief, complete relief must have been accompanied by 24 hours without another heartburn episode after taking study drug.

    Measured: On-Demand Treatment Period: Day 1 to Day 42

Secondary outcomes (6)

  1. Percentage of Evaluable Heartburn Episodes Completely Relieved Within 3 Hours After Taking Study Drug

    An evaluable heartburn episode was an episode for which study drug was taken and for which the participant completed at least one entry in the heartburn episode diary.

    For a heartburn episode to be considered completely relieved, a participant must not have taken rescue antacid within 3 hours of taking study drug.

    Measured: On-Demand Treatment Period: Day 1 to Day 42

  2. Percentage of Evaluable Heartburn Episodes for Each Participant That Are Completely Relieved Within 3 Hours and With No Further Heartburn Reported for 24 Hours After Taking Study Drug

    An evaluable heartburn episode was an episode for which study drug was taken and for which the participant completed at least one entry in the heartburn episode diary.

    For a heartburn episode to be considered completely relieved, a participant must not have taken rescue antacid within 3 hours of taking study drug. For sustained relief, complete relief must have been accompanied by 24 hours without another heartburn episode after taking study drug.

    Measured: On-Demand Treatment Period: Day 1 to Day 42

  3. Mean Number of Tablets of Rescue Antacid Taken Per Day Over the On-Demand Treatment Period

    Measured: On-Demand Treatment Period: Day 1 to Day 42

  4. Percentage of Participants With Complete Relief of Heartburn Within 3 Hours After the First Episode and With No Further Heartburn Reported for 24 Hours After Taking Study Drug

    An evaluable heartburn episode was an episode for which study drug was taken and for which the participant completed at least one entry in the heartburn episode diary.

    For a heartburn episode to be considered completely relieved, a participant must not have taken rescue antacid within 3 hours of taking study drug. For sustained relief, complete relief must have been accompanied by 24 hours without another heartburn episode after taking study drug.

    Measured: On-Demand Treatment Period: Day 1 to Day 42

  5. Percentage of Days Study Drug Was Taken Over the On-Demand Treatment Period

    Measured: On-Demand Treatment Period: Day 1 to Day 42

  6. Percentage of 24-Hour Heartburn-Free Days Over the On-Demand Treatment Period

    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: On-Demand Treatment Period: Day 1 to Day 42

Timeline

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

  1. First posted16 Mar 2021
  2. Study start25 Mar 2021
  3. Primary completion16 Dec 2021
  4. Study completion17 Jan 2022

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
458 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04799158
Sponsor's protocol ID
NERD-201
Status last verified
Dec 2022
First submitted
11 Mar 2021
Last updated
4 Jan 2023
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: Data from this study will be published; however, it is undecided if patient level data will be made available at this time.

Publications

  • Fass R, Vaezi M, Sharma P, Yadlapati R, Hunt B, Harris T, Smith N, Leifke E, Armstrong D. Randomised clinical trial: Efficacy and safety of on-demand vonoprazan versus placebo for non-erosive reflux disease. Aliment Pharmacol Ther. 2023 Nov;58(10):1016-1027. doi: 10.1111/apt.17728. Epub 2023 Sep 26.

    PubMed 37750406

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Vonoprazan in people with Non-Erosive Gastro-Esophageal Reflux Disease and Heartburn, run by Phathom Pharmaceuticals, Inc. at 63 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 11 inclusion and 26 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 4 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 63 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 4 Jan 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 Evaluable Heartburn Episodes Completely Relieved Within 3 Hours and With No Further Heartburn Reported for 24 Hours After Taking Study Drug (time frame: On-Demand Treatment Period: Day 1 to Day 42). 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 NCT04799158, 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 4 Jan 2023.

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