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)
NCT ID: NCT05195528
Last Updated: 2023-12-29
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
776 participants
INTERVENTIONAL
2022-01-17
2023-05-17
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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.
Vonoprazan
Orally via capsule
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.
Vonoprazan
Orally via capsule
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.
Placebo
Orally via capsule
Interventions
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Vonoprazan
Orally via capsule
Placebo
Orally via capsule
Eligibility Criteria
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Inclusion Criteria
2. In the opinion of the investigator or subinvestigators, the participant is capable of understanding and complying with protocol requirements, 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 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.
Exclusion Criteria
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 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.
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 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.
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 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.
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 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).
21. 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.
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. 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).
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).
18 Years
ALL
No
Sponsors
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Phathom Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Phathom Pharmaceuticals
Locations
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North Alabama Research Center LLC
Athens, Alabama, United States
Cullman Research Center
Cullman, Alabama, United States
Medical Affiliated Research Center Inc
Huntsville, Alabama, United States
East View Medical Research, LLC
Mobile, Alabama, United States
Elite Clinical Studies - Phoenix - Clinedge
Phoenix, Arizona, United States
Del Sol Research Management - Clinedge
Tucson, Arizona, United States
Preferred Research Partners - ClinEdge
Little Rock, Arkansas, United States
Arkansas Gastroenterology
North Little Rock, Arkansas, United States
Alliance Research Institute
Canoga Park, California, United States
GW Research, Inc
Chula Vista, California, United States
eStudy Site
Chula Vista, California, United States
Kindred Medical Institute for Clinical Trials, LLC
Corona, California, United States
BG Clinical Research
Encinitas, California, United States
Paragon Rx Clinical
Garden Grove, California, United States
OM Research LLC
Lancaster, California, United States
Torrance Clinical Research Institute
Lomita, California, United States
Prospective Research Innovations
Rancho Cucamonga, California, United States
Northern California Research Corp
Sacramento, California, United States
Digestive Care Center
San Carlos, California, United States
Clinical Applications Laboratories Inc
San Diego, California, United States
Medical Associates Research Group, Inc.
San Diego, California, United States
Paragon Rx Clinical, Inc.
Santa Ana, California, United States
Western States Clinical Research Inc
Wheat Ridge, Colorado, United States
Gastroenterology Associates of Fairfield County
Bridgeport, Connecticut, United States
Connecticut Clinical Research Institute
Bristol, Connecticut, United States
Medical Research Center of Connecticut, LLC
Hamden, Connecticut, United States
Velocity Clinical Research - New Smyrna Beach
Edgewater, Florida, United States
Nature Coast Clinical Research
Inverness, Florida, United States
ENCORE Borland-Groover Clinical Research
Jacksonville, Florida, United States
ClinCloud
Maitland, Florida, United States
Legacy Clinical Solutions: Sensible HealthCare, LLC
Ocoee, Florida, United States
Digestive Disease Consultants, PA
Orange Park, Florida, United States
Medical Center
Orlando, Florida, United States
Advanced Gastroenterology Associates, LLC
Palm Harbor, Florida, United States
Precision Clinical Research
Sunrise, Florida, United States
Guardian Angel Research
Tampa, Florida, United States
Southeast Clinical Research Center
Dalton, Georgia, United States
Atlanta Center For Gastroenterology PC
Decatur, Georgia, United States
Gastroenterology Associates of Central Georgia, LLC
Macon, Georgia, United States
Atlanta Center For Clinical Research
Roswell, Georgia, United States
Mount Vernon Clinical Research, LLC
Sandy Springs, Georgia, United States
In Quest Medical Research
Suwanee, Georgia, United States
Treasure Valley Medical Research
Boise, Idaho, United States
Grand Teton Research Group, PLLC
Idaho Falls, Idaho, United States
Iowa Digestive Disease Center
Clive, Iowa, United States
Kansas Medical Clinic
Topeka, Kansas, United States
Clinical Trials Management LLC
Covington, Louisiana, United States
Combined Gastro Research
Lafayette, Louisiana, United States
Tandem Clinical Research, LLC
Marrero, Louisiana, United States
Clinical Trials of America, LLC
West Monroe, Louisiana, United States
Investigative Clinical Research
Annapolis, Maryland, United States
Digestive Health Specialists
Chelmsford, Massachusetts, United States
Gastroenterology Associates of Western Michigan, PLC
Wyoming, Michigan, United States
MNGI Digestive Health
Minneapolis, Minnesota, United States
Minnesota Gastroenterology PA
Plymouth, Minnesota, United States
Clinical Research Professionals
Chesterfield, Missouri, United States
Quality Clinical Research - HyperCore
Omaha, Nebraska, United States
Sierra Clinical Research
Las Vegas, Nevada, United States
Office of Site 1
Las Vegas, Nevada, United States
Office of Site 2
Las Vegas, Nevada, United States
Advanced Research Institute
Reno, Nevada, United States
The Gastroenterology Group of Northern NJ LLC
Englewood, New Jersey, United States
Allied Health Clinical Research Organization
Freehold, New Jersey, United States
NY Scientific
Brooklyn, New York, United States
Drug Trials America
Hartsdale, New York, United States
Care Access Research
New York, New York, United States
UNC Medical Center
Chapel Hill, North Carolina, United States
Charlotte Gastroenterology and Hepatology PLLC
Charlotte, North Carolina, United States
Peters Medical Research, LLC
High Point, North Carolina, United States
East Carolina Gastroenterology
Jacksonville, North Carolina, United States
Clinical Trials of America-NC, LLC
Mount Airy, North Carolina, United States
Trial Management Associates LLC
Wilmington, North Carolina, United States
Lillestol Research
Fargo, North Dakota, United States
Gastro Health Research
Cincinnati, Ohio, United States
Remington Davis Clinical Research
Columbus, Ohio, United States
Great Lakes Medical Research LLC
Mentor, Ohio, United States
North Shore Gastroenterology
Westlake, Ohio, United States
Susquehanna Research Group, LLC
Harrisburg, Pennsylvania, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Frontier Clinical Research, LLC
Uniontown, Pennsylvania, United States
Velocity Clinical Research - Providence
East Greenwich, Rhode Island, United States
Gastroenterology Associates, PA of Greenville
Greenville, South Carolina, United States
Gastro One
Cordova, Tennessee, United States
Galen Medical Group
Hixson, Tennessee, United States
Clinical Research Associates Inc
Nashville, Tennessee, United States
QUALITY Medical Research
Nashville, Tennessee, United States
Vanderbilt Digestive Disease Center
Nashville, Tennessee, United States
Gastroenterology Consultants of South Texas, PLLC
Brownsville, Texas, United States
Digestive Health Associates of Texas, PA
Carrollton, Texas, United States
Family Medicine Associates of Texas
Carrollton, Texas, United States
Texas Tech Physicians of El Paso
El Paso, Texas, United States
Digestive Health Associates of Texas, P.A.dba DHAT Research Institute
Garland, Texas, United States
Primecare Medical Group
Houston, Texas, United States
Biopharma Informatic, LLC
Houston, Texas, United States
Rio Grande Gastroenterology
McAllen, Texas, United States
Quality Research Inc
San Antonio, Texas, United States
Gastroenterology Research of San Antonio (GERSA)
San Antonio, Texas, United States
Southern Star Research Institute LLC
San Antonio, Texas, United States
Sherman Clinical Research
Sherman, Texas, United States
Texas Digestive Disease Consultants
Southlake, Texas, United States
GI Alliance
Southlake, Texas, United States
Texas Gastro Consultants
Tomball, Texas, United States
Advanced Research Institute
Ogden, Utah, United States
Kalo Clinical Research
Salt Lake City, Utah, United States
Advanced Research Institute
Sandy City, Utah, United States
Blue Ridge Medical Research
Lynchburg, Virginia, United States
Clinical Research Partners LLC
Richmond, Virginia, United States
Washington Gastroenterology
Bellevue, Washington, United States
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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NERD-301
Identifier Type: -
Identifier Source: org_study_id