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CompletedNCT05195528Updated Dec 29, 2023Results posted

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 interventional study of Vonoprazan and Placebo in Non-Erosive Gastro-Esophageal Reflux Disease and Heartburn, sponsored by Phathom Pharmaceuticals, Inc.. Completed at 108 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-12-29.

Sponsored by Phathom Pharmaceuticals, Inc. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
776
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Non-Erosive Gastro-Esophageal Reflux Disease
  • Heartburn

Browse trials for

Keywords

  • NERD
  • Vonoprazan
03

In context

Heartburn

154 studies on the registry are indexed under Heartburn; 12 are open to participants now.

This study's enrollment of 776 is above the median of 100 across 127 interventional studies indexed under Heartburn.

Browse Heartburn studies →

Lead sponsor

Phathom Pharmaceuticals, Inc. is the lead sponsor of 15 studies on the registry; 2 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 11 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. The participant is ≥18 years of age at the time of signing.
  2. 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.
  3. 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.
  4. 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.
  5. History of onset of heartburn at least 6 months prior to the Screening Period.
  6. Heartburn reported on 4 or more days during any consecutive 7-day period of the Screening Period as recorded in the electronic diary.
  7. A female participant of who is or may be sexually active with a non-sterilized male partner agrees to routinely use adequate from the signing of informed consent until 4 weeks after the last dose of study drug.

Exclusion criteria

Exclusion Criteria:

  1. 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).
  2. The participant has active irritable bowel syndrome (IBS) or has had a flare of IBS requiring therapy within the prior 6 months.

  3. The participant has a history of or is suspected of having functional upper gastrointestinal disorders, such as:

    1. Functional heartburn, as described in the Rome IV Criteria.
    2. Functional dyspepsia, as described in the Rome IV Criteria.
  4. The participant has endoscopic Barrett's esophagus (>1 cm of columnar-lined esophagus) and/or definite dysplastic changes in the esophagus.
  5. 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) or hiatal hernia are eligible to participate.
  6. The participant has scleroderma (systemic sclerosis) or systemic lupus erythematosus.
  7. 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).
  8. The participant has an active gastric or duodenal ulcer within 4 weeks before the first dose of study drug.
  9. 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.
  10. The participant has received any 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.
  11. 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.
  12. The participant has had clinically significant upper or lower gastrointestinal bleeding within 4 weeks prior to the Screening Period.
  13. The participant has Zollinger-Ellison syndrome or other gastric acid hypersecretory conditions.
  14. The participant has a history of or allergies to vonoprazan (including the formulation : 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.
  15. 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.
  16. The participant is taking any excluded medications or treatments listed in the protocol, including prescription cannabinoids/tetrahydrocannabinol.
  17. 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.
  18. 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.
  19. 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.
  20. The participant has a history of (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).
  21. The participant has acquired immunodeficiency syndrome or infection, or tests positive for the surface antigen, 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.

  22. 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. (ALT) or aspartate aminotransferase (AST) >2 × the (ULN) or total >2 × ULN (except for participants with a diagnosis of Gilbert's syndrome).
  23. 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).
Terms in these criteria, in plain language(14)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
776 participants (actual)

Study arms

  • Experimental
    Vonoprazan 10 mg

    Participants 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.

    Drug: Vonoprazan

  • Experimental
    Vonoprazan 20 mg

    Participants 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.

    Drug: Vonoprazan

  • Placebo comparator
    Placebo

    Participants 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.

    Drug: Placebo

Interventions

  • DrugVonoprazan

    Orally via capsule

  • DrugPlacebo

    Orally via capsule

06

What researchers measure

Primary outcomes

  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.

    Time frame: Day 1 to Day 28

Secondary outcomes

  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.

    Time frame: Day 1 to Day 28

07

Results

Posted Dec 29, 2023

Participant flow

Participants were recruited across 91 sites in the United States in the period of time from January 2022 to May 2023. Participants were in the study for a period of time up to 33 weeks.

Placebo-controlled Treatment Period
Participant flow — Placebo-controlled Treatment Period
MilestonePlaceboVonoprazan 10 mgVonoprazan 20 mgPlacebo/Vonoprazan 10 mgPlacebo/Vonoprazan 20 mg
Started25925825900
Intent to treat analysis set25825725700
Safety analysis set25625925700
Completed24725024200
Not completed1281700
Withdrew: Protocol violation11000
Withdrew: Pre-treatment event (pte) or adverse event (ae) or serious adverse event (sae)21600
Withdrew: Lost to follow-up03400
Withdrew: Withdrawal by subject62400
Withdrew: Lack of efficacy20000
Withdrew: Not treated11200
Withdrew: Other00100
Extension Period
Participant flow — Extension Period
MilestonePlaceboVonoprazan 10 mgVonoprazan 20 mgPlacebo/Vonoprazan 10 mgPlacebo/Vonoprazan 20 mg
Started0247237122122
Intent to treat analysis set0247235119122
Safety analysis set0248236118121
Completed0219206106103
Not completed028311619
Withdrew: Pte or ae or sae04544
Withdrew: Protocol violation02101
Withdrew: Lost to follow-up061337
Withdrew: Withdrawal by subject012965
Withdrew: Lack of efficacy03002
Withdrew: Not treated00230
Withdrew: Other01100

Outcome measures

PrimaryPercentage 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.

Time frame:
Day 1 to Day 28
Reported as:
Least squares mean · Percentage of days
Percentage of Days Without Daytime or Nighttime Heartburn
Percentage of daysPlaceboVonoprazan 10 mgVonoprazan 20 mg
Percentage of Days Without Daytime or Nighttime Heartburn27.7 (23.92 to 31.46)44.8 (41.06 to 48.58)44.4 (40.62 to 48.15)
Statistical analysis
  • Placebo vs Vonoprazan 10 mg · General linear model · p = <0.0001 (P-values were obtained from the general linear model with treatment group as factor and severity and frequency of heartburn at baseline as covariates.) · Difference in least square mean: 17.1 · 95% CI 11.81 to 22.45
  • Placebo vs Vonoprazan 20 mg · General linear model · p = <0.0001 (P-values were obtained from the general linear model with treatment group as factor and severity and frequency of heartburn at baseline as covariates.) · Least square mean difference: 16.7 · 95% CI 11.36 to 22.04
SecondaryPercentage 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.

Time frame:
Day 1 to Day 28
Reported as:
Least squares mean · Percentage of days
Percentage of Days Without Rescue Antacid Use
Percentage of daysPlaceboVonoprazan 10 mgVonoprazan 20 mg
Percentage of Days Without Rescue Antacid Use47.6 (43.43 to 51.68)63.3 (59.19 to 67.45)61.2 (57.12 to 65.36)
Statistical analysis
  • Placebo vs Vonoprazan 10 mg · General linear model · p = <0.0001 (P-values were obtained from the general linear model with treatment group as factor and severity and frequency of heartburn at baseline as covariates.) · Least square mean difference: 15.8 · 95% CI 9.93 to 21.60
  • Placebo vs Vonoprazan 20 mg · General linear model · p = <0.0001 (P-values were obtained from the general linear model with treatment group as factor and severity and frequency of heartburn at baseline as covariates.) · Least square mean difference: 13.7 · 95% CI 7.84 to 19.54

Adverse events

Collected over All-cause mortality was collected from time of enrollment through 33 weeks (5 weeks screening, 4 weeks Placebo-controlled Treatment Period, 20 weeks Extension Period, 4 weeks follow-up). Treatment-emergent adverse events were collected from first dose of study treatment through 28 weeks.. Non-serious events are listed at a 2% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo (Part 1: 4 Weeks)0/259 (0%)0/256 (0%)17/256 (6.6%)
Vonoprazan 10 mg (Part 1: 4 Weeks)0/258 (0%)1/259 (0.4%)28/259 (10.8%)
Vonoprazan 20 mg (Part 1: 4 Weeks) Part 10/259 (0%)2/257 (0.8%)32/257 (12.5%)
Placebo/Vonoprazan 10 mg (Part 2: 20 Weeks)0/122 (0%)2/118 (1.7%)26/118 (22%)
Placebo/Vonoprazan 20 mg (Part 2: 20 Weeks)0/122 (0%)4/121 (3.3%)11/121 (9.1%)
Vonoprazan 10 mg/Vonoprazan 10 mg (Part 2: 20 Weeks)0/247 (0%)7/248 (2.8%)40/248 (16.1%)
Vonoprazan 20/Vonoprazan 20 mg (Part 2: 20 Weeks)0/237 (0%)3/236 (1.3%)45/236 (19.1%)
Most frequent serious events
Showing 10 of 17
Most frequent serious events
EventPlacebo (Part 1: 4 Weeks)Vonoprazan 10 mg (Part 1: 4 Weeks)Vonoprazan 20 mg (Part 1: 4 Weeks) Part 1Placebo/Vonoprazan 10 mg (Part 2: 20 Weeks)Placebo/Vonoprazan 20 mg (Part 2: 20 Weeks)Vonoprazan 10 mg/Vonoprazan 10 mg (Part 2: 20 Weeks)Vonoprazan 20/Vonoprazan 20 mg (Part 2: 20 Weeks)
Angina pectorisCardiac disorders0/2560/2590/2571/1180/1210/2480/236
Cerebrovascular accidentNervous system disorders0/2560/2590/2571/1180/1210/2480/236
Cholecystitis acuteHepatobiliary disorders0/2560/2590/2570/1181/1211/2480/236
Abdominal pain upperGastrointestinal disorders0/2560/2590/2570/1181/1210/2480/236
Non-cardiac chest painGeneral disorders0/2560/2590/2570/1181/1211/2480/236
Bipolar disorderPsychiatric disorders0/2560/2590/2570/1181/1210/2480/236
CholelithiasisHepatobiliary disorders0/2560/2590/2570/1180/1212/2481/236
ConstipationGastrointestinal disorders0/2560/2590/2570/1180/1210/2481/236
Intervertebral disc protrusionMusculoskeletal and connective tissue disorders0/2560/2590/2570/1180/1210/2481/236
CholecystitisHepatobiliary disorders0/2560/2590/2570/1180/1211/2480/236
Most frequent other events
Showing 10 of 11
Most frequent other events
EventPlacebo (Part 1: 4 Weeks)Vonoprazan 10 mg (Part 1: 4 Weeks)Vonoprazan 20 mg (Part 1: 4 Weeks) Part 1Placebo/Vonoprazan 10 mg (Part 2: 20 Weeks)Placebo/Vonoprazan 20 mg (Part 2: 20 Weeks)Vonoprazan 10 mg/Vonoprazan 10 mg (Part 2: 20 Weeks)Vonoprazan 20/Vonoprazan 20 mg (Part 2: 20 Weeks)
COVID-19Infections and infestations2/2563/2594/25712/1183/12111/24820/236
Upper respiratory tract infectionInfections and infestations1/2560/2592/2572/1181/12112/2485/236
InfluenzaInfections and infestations1/2560/2591/2574/1182/1215/2483/236
SinusitisInfections and infestations0/2562/2591/2572/1182/1218/2483/236
NauseaGastrointestinal disorders1/2566/2598/2571/1181/1213/2485/236
Urinary tract infectionInfections and infestations3/2564/2594/2572/1180/1215/2486/236
Abdominal painGastrointestinal disorders2/2564/2596/2572/1181/1211/2483/236
ConstipationGastrointestinal disorders2/2566/2592/2571/1180/1213/2481/236
DiarrhoeaGastrointestinal disorders3/2566/2591/2572/1182/1213/2482/236
GastroenteritisInfections and infestations1/2560/2590/2572/1181/1211/2485/236

Baseline characteristics

Data is presented for the Placebo-controlled treatment Period, ITT population.

Age, Continuous
Age, Continuous(Years)PlaceboVonoprazan 10 mgVonoprazan 20 mgTotal
Mean51.5 ± 14.7451 ± 14.0350.4 ± 14.3950.9 ± 14.38
Sex: Female, Male
Sex: Female, Male(Participants)PlaceboVonoprazan 10 mgVonoprazan 20 mgTotal
Female179182166527
Male797591245
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)PlaceboVonoprazan 10 mgVonoprazan 20 mgTotal
Hispanic or Latino778780244
Not Hispanic or Latino180165171516
Unknown or Not Reported15612
Race (NIH/OMB)
Race (NIH/OMB)(Participants)PlaceboVonoprazan 10 mgVonoprazan 20 mgTotal
American Indian or Alaska Native1304
Asian12221145
Native Hawaiian or Other Pacific Islander0000
Black or African American333852123
White205186185576
More than one race34411
Unknown or Not Reported44513
08

Study locations

108 sites
  • North Alabama Research Center LLC
    Athens, Alabama 35611-2456, United States
  • Cullman Research Center
    Cullman, Alabama 35055, United States
  • Medical Affiliated Research Center Inc
    Huntsville, Alabama 35801-6002, United States
  • East View Medical Research, LLC
    Mobile, Alabama 36606, United States
  • Elite Clinical Studies - Phoenix - Clinedge
    Phoenix, Arizona 85018-5434, United States
  • Del Sol Research Management - Clinedge
    Tucson, Arizona 85715-3834, United States
  • Preferred Research Partners - ClinEdge
    Little Rock, Arkansas 72211-3868, United States
  • Arkansas Gastroenterology
    North Little Rock, Arkansas 72117-2924, United States
  • Alliance Research Institute
    Canoga Park, California 91304-3862, United States
  • GW Research, Inc
    Chula Vista, California 91910-3906, United States
  • eStudy Site
    Chula Vista, California 91911-6660, United States
  • Kindred Medical Institute for Clinical Trials, LLC
    Corona, California 92879-3124, United States
  • BG Clinical Research
    Encinitas, California 92024, United States
  • Paragon Rx Clinical
    Garden Grove, California 92840-3103, United States
  • OM Research LLC
    Lancaster, California 93534, United States
  • Torrance Clinical Research Institute
    Lomita, California 90717-2101, United States
  • Prospective Research Innovations
    Rancho Cucamonga, California 91730, United States
  • Northern California Research Corp
    Sacramento, California 95821-2640, United States
  • Digestive Care Center
    San Carlos, California 94070-3939, United States
  • Clinical Applications Laboratories Inc
    San Diego, California 92103-5639, United States
  • Medical Associates Research Group, Inc.
    San Diego, California 92123-4207, United States
  • Paragon Rx Clinical, Inc.
    Santa Ana, California 92703-1811, United States
  • Western States Clinical Research Inc
    Wheat Ridge, Colorado 80033-6800, United States
  • Gastroenterology Associates of Fairfield County
    Bridgeport, Connecticut 06606-5301, United States
  • Connecticut Clinical Research Institute
    Bristol, Connecticut 06010-5161, United States
  • Medical Research Center of Connecticut, LLC
    Hamden, Connecticut 06518, United States
  • Velocity Clinical Research - New Smyrna Beach
    Edgewater, Florida 32132-2720, United States
  • Nature Coast Clinical Research
    Inverness, Florida 34452-4717, United States
  • ENCORE Borland-Groover Clinical Research
    Jacksonville, Florida 32256-6004, United States
  • ClinCloud
    Maitland, Florida 32751-5570, United States
  • Legacy Clinical Solutions: Sensible HealthCare, LLC
    Ocoee, Florida 34761-2964, United States
  • Digestive Disease Consultants, PA
    Orange Park, Florida 32073-4752, United States
  • Medical Center
    Orlando, Florida 32807-4346, United States
  • Advanced Gastroenterology Associates, LLC
    Palm Harbor, Florida 34684-2648, United States
  • Precision Clinical Research
    Sunrise, Florida 33351-7311, United States
  • Guardian Angel Research
    Tampa, Florida 33614-2700, United States
  • Southeast Clinical Research Center
    Dalton, Georgia 30720, United States
  • Atlanta Center For Gastroenterology PC
    Decatur, Georgia 30033-6146, United States
  • Gastroenterology Associates of Central Georgia, LLC
    Macon, Georgia 31201-3262, United States
  • Atlanta Center For Clinical Research
    Roswell, Georgia 30075-2456, United States
  • Mount Vernon Clinical Research, LLC
    Sandy Springs, Georgia 30328-4277, United States
  • In Quest Medical Research
    Suwanee, Georgia 30024-9134, United States
  • Treasure Valley Medical Research
    Boise, Idaho 83706-1345, United States
  • Grand Teton Research Group, PLLC
    Idaho Falls, Idaho 83404-7590, United States
  • Iowa Digestive Disease Center
    Clive, Iowa 50325-8151, United States
  • Kansas Medical Clinic
    Topeka, Kansas 66606-1707, United States
  • Clinical Trials Management LLC
    Covington, Louisiana 70433-4966, United States
  • Combined Gastro Research
    Lafayette, Louisiana 70503-2636, United States
  • Tandem Clinical Research, LLC
    Marrero, Louisiana 70072-3151, United States
  • Clinical Trials of America, LLC
    West Monroe, Louisiana 71291-5324, United States
  • Investigative Clinical Research
    Annapolis, Maryland 21401-1091, United States
  • Digestive Health Specialists
    Chelmsford, Massachusetts 01824-2775, United States
  • Gastroenterology Associates of Western Michigan, PLC
    Wyoming, Michigan 49519-9691, United States
  • MNGI Digestive Health
    Minneapolis, Minnesota 55413, United States
  • Minnesota Gastroenterology PA
    Plymouth, Minnesota 55446-3661, United States
  • Clinical Research Professionals
    Chesterfield, Missouri 63005-1248, United States
  • Quality Clinical Research - HyperCore
    Omaha, Nebraska 68114-3723, United States
  • Sierra Clinical Research
    Las Vegas, Nevada 89106-4159, United States
  • Office of Site 1
    Las Vegas, Nevada 89119-5190, United States
  • Office of Site 2
    Las Vegas, Nevada 89128-0802, United States
  • Advanced Research Institute
    Reno, Nevada 89511-2060, United States
  • The Gastroenterology Group of Northern NJ LLC
    Englewood, New Jersey 07631-4141, United States
  • Allied Health Clinical Research Organization
    Freehold, New Jersey 07728-2974, United States
  • NY Scientific
    Brooklyn, New York 11235, United States
  • Drug Trials America
    Hartsdale, New York 10530-1837, United States
  • Care Access Research
    New York, New York 10065-8559, United States
  • UNC Medical Center
    Chapel Hill, North Carolina 27514-4220, United States
  • Charlotte Gastroenterology and Hepatology PLLC
    Charlotte, North Carolina 28207-1200, United States
  • Peters Medical Research, LLC
    High Point, North Carolina 27260, United States
  • East Carolina Gastroenterology
    Jacksonville, North Carolina 28546-7325, United States
  • Clinical Trials of America-NC, LLC
    Mount Airy, North Carolina 27030-4459, United States
  • Trial Management Associates LLC
    Wilmington, North Carolina 28403-7018, United States
  • Lillestol Research
    Fargo, North Dakota 58104-4557, United States
  • Gastro Health Research
    Cincinnati, Ohio 45219, United States
  • Remington Davis Clinical Research
    Columbus, Ohio 43215-7098, United States
  • Great Lakes Medical Research LLC
    Mentor, Ohio 44060-6211, United States
  • North Shore Gastroenterology
    Westlake, Ohio 44145-7215, United States
  • Susquehanna Research Group, LLC
    Harrisburg, Pennsylvania 17110-3673, United States
  • University of Pennsylvania
    Philadelphia, Pennsylvania 19104-5127, United States
  • Frontier Clinical Research, LLC
    Uniontown, Pennsylvania 15401-9069, United States
  • Velocity Clinical Research - Providence
    East Greenwich, Rhode Island 02818-1762, United States
  • Gastroenterology Associates, PA of Greenville
    Greenville, South Carolina 29615, United States
  • Gastro One
    Cordova, Tennessee 38018, United States
  • Galen Medical Group
    Hixson, Tennessee 37343, United States
  • Clinical Research Associates Inc
    Nashville, Tennessee 37203-2066, United States
  • QUALITY Medical Research
    Nashville, Tennessee 37211-4981, United States
  • Vanderbilt Digestive Disease Center
    Nashville, Tennessee 37232-0028, United States
  • Gastroenterology Consultants of South Texas, PLLC
    Brownsville, Texas 78550, United States
  • Digestive Health Associates of Texas, PA
    Carrollton, Texas 75010-4545, United States
  • Family Medicine Associates of Texas
    Carrollton, Texas 75010, United States
  • Texas Tech Physicians of El Paso
    El Paso, Texas 79905-2707, United States
  • Digestive Health Associates of Texas, P.A.dba DHAT Research Institute
    Garland, Texas 75044-2210, United States
  • Primecare Medical Group
    Houston, Texas 77024-2593, United States
  • Biopharma Informatic, LLC
    Houston, Texas 77084, United States
  • Rio Grande Gastroenterology
    McAllen, Texas 78503, United States
  • Quality Research Inc
    San Antonio, Texas 78209-1744, United States
  • Gastroenterology Research of San Antonio (GERSA)
    San Antonio, Texas 78229-3270, United States
  • Southern Star Research Institute LLC
    San Antonio, Texas 78229-4894, United States
  • Sherman Clinical Research
    Sherman, Texas 75092, United States
  • Texas Digestive Disease Consultants
    Southlake, Texas 76092-9167, United States

Showing the first 100 of 108 sites. Choose a country and city above to see the rest.

09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 29, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT05195528
Lead sponsor
Phathom Pharmaceuticals, Inc.
Responsible party
Sponsor
First posted
Jan 19, 2022
Start date
Jan 17, 2022
Primary completion
Nov 21, 2022
Completion
May 17, 2023
Results posted
Dec 29, 2023
Last update
Dec 29, 2023

Study contacts

Medical Director
study director · Phathom Pharmaceuticals

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Vonoprazan

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Phathom Pharmaceuticals, Inc.

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