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)

NCT05195528 | Completed Phase 3 Results FDA Drug

• 1 other identifier: NERD-301
• Study Type: interventional
• Target: 776
• Locations: 1 country
• Sites: 108

Brief 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.

Conditions

Non-Erosive Gastro-Esophageal Reflux Disease; Heartburn

Keywords

NERD; Vonoprazan

Outcome Measures

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.

  Day 1 to Day 28

Secondary Outcomes (1)

• Percentage of Days Without Rescue Antacid Use

  Day 1 to Day 28

Study Arms (3)

Vonoprazan 10 mg

EXPERIMENTAL

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

Vonoprazan 20 mg

EXPERIMENTAL

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

PLACEBO COMPARATOR

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

Vonoprazan DRUG

Orally via capsule

Vonoprazan 10 mg; Vonoprazan 20 mg

Placebo DRUG

Orally via capsule

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Phathom Pharmaceuticals, Inc.: lead

Study Sites (108)

North Alabama Research Center LLC

Athens, Alabama, 35611-2456, United States

Location

Cullman Research Center

Cullman, Alabama, 35055, United States

Location

Medical Affiliated Research Center Inc

Huntsville, Alabama, 35801-6002, United States

Location

East View Medical Research, LLC

Mobile, Alabama, 36606, United States

Location

Elite Clinical Studies - Phoenix - Clinedge

Phoenix, Arizona, 85018-5434, United States

Location

Del Sol Research Management - Clinedge

Tucson, Arizona, 85715-3834, United States

Location

Preferred Research Partners - ClinEdge

Little Rock, Arkansas, 72211-3868, United States

Location

Arkansas Gastroenterology

North Little Rock, Arkansas, 72117-2924, United States

Location

Alliance Research Institute

Canoga Park, California, 91304-3862, United States

Location

GW Research, Inc

Chula Vista, California, 91910-3906, United States

Location

eStudy Site

Chula Vista, California, 91911-6660, United States

Location

Kindred Medical Institute for Clinical Trials, LLC

Corona, California, 92879-3124, United States

Location

BG Clinical Research

Encinitas, California, 92024, United States

Location

Paragon Rx Clinical

Garden Grove, California, 92840-3103, United States

Location

OM Research LLC

Lancaster, California, 93534, United States

Location

Torrance Clinical Research Institute

Lomita, California, 90717-2101, United States

Location

Prospective Research Innovations

Rancho Cucamonga, California, 91730, United States

Location

Northern California Research Corp

Sacramento, California, 95821-2640, United States

Location

Digestive Care Center

San Carlos, California, 94070-3939, United States

Location

Clinical Applications Laboratories Inc

San Diego, California, 92103-5639, United States

Location

Medical Associates Research Group, Inc.

San Diego, California, 92123-4207, United States

Location

Paragon Rx Clinical, Inc.

Santa Ana, California, 92703-1811, United States

Location

Western States Clinical Research Inc

Wheat Ridge, Colorado, 80033-6800, United States

Location

Gastroenterology Associates of Fairfield County

Bridgeport, Connecticut, 06606-5301, United States

Location

Connecticut Clinical Research Institute

Bristol, Connecticut, 06010-5161, United States

Location

Medical Research Center of Connecticut, LLC

Hamden, Connecticut, 06518, United States

Location

Velocity Clinical Research - New Smyrna Beach

Edgewater, Florida, 32132-2720, United States

Location

Nature Coast Clinical Research

Inverness, Florida, 34452-4717, United States

Location

ENCORE Borland-Groover Clinical Research

Jacksonville, Florida, 32256-6004, United States

Location

ClinCloud

Maitland, Florida, 32751-5570, United States

Location

Legacy Clinical Solutions: Sensible HealthCare, LLC

Ocoee, Florida, 34761-2964, United States

Location

Digestive Disease Consultants, PA

Orange Park, Florida, 32073-4752, United States

Location

Medical Center

Orlando, Florida, 32807-4346, United States

Location

Advanced Gastroenterology Associates, LLC

Palm Harbor, Florida, 34684-2648, United States

Location

Precision Clinical Research

Sunrise, Florida, 33351-7311, United States

Location

Guardian Angel Research

Tampa, Florida, 33614-2700, United States

Location

Southeast Clinical Research Center

Dalton, Georgia, 30720, United States

Location

Atlanta Center For Gastroenterology PC

Decatur, Georgia, 30033-6146, United States

Location

Gastroenterology Associates of Central Georgia, LLC

Macon, Georgia, 31201-3262, United States

Location

Atlanta Center For Clinical Research

Roswell, Georgia, 30075-2456, United States

Location

Mount Vernon Clinical Research, LLC

Sandy Springs, Georgia, 30328-4277, United States

Location

In Quest Medical Research

Suwanee, Georgia, 30024-9134, United States

Location

Treasure Valley Medical Research

Boise, Idaho, 83706-1345, United States

Location

Grand Teton Research Group, PLLC

Idaho Falls, Idaho, 83404-7590, United States

Location

Iowa Digestive Disease Center

Clive, Iowa, 50325-8151, United States

Location

Kansas Medical Clinic

Topeka, Kansas, 66606-1707, United States

Location

Clinical Trials Management LLC

Covington, Louisiana, 70433-4966, United States

Location

Combined Gastro Research

Lafayette, Louisiana, 70503-2636, United States

Location

Tandem Clinical Research, LLC

Marrero, Louisiana, 70072-3151, United States

Location

Clinical Trials of America, LLC

West Monroe, Louisiana, 71291-5324, United States

Location

Investigative Clinical Research

Annapolis, Maryland, 21401-1091, United States

Location

Digestive Health Specialists

Chelmsford, Massachusetts, 01824-2775, United States

Location

Gastroenterology Associates of Western Michigan, PLC

Wyoming, Michigan, 49519-9691, United States

Location

MNGI Digestive Health

Minneapolis, Minnesota, 55413, United States

Location

Minnesota Gastroenterology PA

Plymouth, Minnesota, 55446-3661, United States

Location

Clinical Research Professionals

Chesterfield, Missouri, 63005-1248, United States

Location

Quality Clinical Research - HyperCore

Omaha, Nebraska, 68114-3723, United States

Location

Sierra Clinical Research

Las Vegas, Nevada, 89106-4159, United States

Location

Office of Site 1

Las Vegas, Nevada, 89119-5190, United States

Location

Office of Site 2

Las Vegas, Nevada, 89128-0802, United States

Location

Advanced Research Institute

Reno, Nevada, 89511-2060, United States

Location

The Gastroenterology Group of Northern NJ LLC

Englewood, New Jersey, 07631-4141, United States

Location

Allied Health Clinical Research Organization

Freehold, New Jersey, 07728-2974, United States

Location

NY Scientific

Brooklyn, New York, 11235, United States

Location

Drug Trials America

Hartsdale, New York, 10530-1837, United States

Location

Care Access Research

New York, New York, 10065-8559, United States

Location

UNC Medical Center

Chapel Hill, North Carolina, 27514-4220, United States

Location

Charlotte Gastroenterology and Hepatology PLLC

Charlotte, North Carolina, 28207-1200, United States

Location

Peters Medical Research, LLC

High Point, North Carolina, 27260, United States

Location

East Carolina Gastroenterology

Jacksonville, North Carolina, 28546-7325, United States

Location

Clinical Trials of America-NC, LLC

Mount Airy, North Carolina, 27030-4459, United States

Location

Trial Management Associates LLC

Wilmington, North Carolina, 28403-7018, United States

Location

Lillestol Research

Fargo, North Dakota, 58104-4557, United States

Location

Gastro Health Research

Cincinnati, Ohio, 45219, United States

Location

Remington Davis Clinical Research

Columbus, Ohio, 43215-7098, United States

Location

Great Lakes Medical Research LLC

Mentor, Ohio, 44060-6211, United States

Location

North Shore Gastroenterology

Westlake, Ohio, 44145-7215, United States

Location

Susquehanna Research Group, LLC

Harrisburg, Pennsylvania, 17110-3673, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104-5127, United States

Location

Frontier Clinical Research, LLC

Uniontown, Pennsylvania, 15401-9069, United States

Location

Velocity Clinical Research - Providence

East Greenwich, Rhode Island, 02818-1762, United States

Location

Gastroenterology Associates, PA of Greenville

Greenville, South Carolina, 29615, United States

Location

Gastro One

Cordova, Tennessee, 38018, United States

Location

Galen Medical Group

Hixson, Tennessee, 37343, United States

Location

Clinical Research Associates Inc

Nashville, Tennessee, 37203-2066, United States

Location

QUALITY Medical Research

Nashville, Tennessee, 37211-4981, United States

Location

Vanderbilt Digestive Disease Center

Nashville, Tennessee, 37232-0028, United States

Location

Gastroenterology Consultants of South Texas, PLLC

Brownsville, Texas, 78550, United States

Location

Digestive Health Associates of Texas, PA

Carrollton, Texas, 75010-4545, United States

Location

Family Medicine Associates of Texas

Carrollton, Texas, 75010, United States

Location

Texas Tech Physicians of El Paso

El Paso, Texas, 79905-2707, United States

Location

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

Garland, Texas, 75044-2210, United States

Location

Primecare Medical Group

Houston, Texas, 77024-2593, United States

Location

Biopharma Informatic, LLC

Houston, Texas, 77084, United States

Location

Rio Grande Gastroenterology

McAllen, Texas, 78503, United States

Location

Quality Research Inc

San Antonio, Texas, 78209-1744, United States

Location

Gastroenterology Research of San Antonio (GERSA)

San Antonio, Texas, 78229-3270, United States

Location

Southern Star Research Institute LLC

San Antonio, Texas, 78229-4894, United States

Location

Sherman Clinical Research

Sherman, Texas, 75092, United States

Location

Texas Digestive Disease Consultants

Southlake, Texas, 76092-9167, United States

Location

GI Alliance

Southlake, Texas, 76092, United States

Location

Texas Gastro Consultants

Tomball, Texas, 77375-3348, United States

Location

Advanced Research Institute

Ogden, Utah, 84405-4928, United States

Location

Kalo Clinical Research

Salt Lake City, Utah, 84102, United States

Location

Advanced Research Institute

Sandy City, Utah, 84092-4350, United States

Location

Blue Ridge Medical Research

Lynchburg, Virginia, 24502-4272, United States

Location

Clinical Research Partners LLC

Richmond, Virginia, 23226-3787, United States

Location

Washington Gastroenterology

Bellevue, Washington, 98004-4631, United States

Location

Related Publications (2)

• 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. 2025 Oct 13. doi: 10.14309/ajg.0000000000003794. Online ahead of print.

  PMID: 41081570 DERIVED

• 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.

  PMID: 38750866 DERIVED

MeSH Terms

Conditions

Heartburn

Interventions

1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)-N-methylmethanamine

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Phathom Medical Information
• Organization: Phathom Pharmaceuticals, Inc.

medicalinformation@phathompharma.com

1-888-775-7428

Study Officials

• Medical Director

  Phathom Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2022
• First Posted: January 19, 2022
• Study Start: January 17, 2022
• Primary Completion: November 21, 2022
• Study Completion: May 17, 2023
• Last Updated: December 29, 2023
• Results First Posted: December 29, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (108)