Symptomatic Non-erosive Gastroesophageal Reflux Disease study: Vonoprazan
Official title A Study to Evaluate the Efficacy and Safety of Vonoprazan 10 mg Compared to Placebo for Relief of Episodic Heartburn in Participants With Symptomatic Non-Erosive Gastroesophageal Reflux Disease Through 24 Weeks
ClinicalTrials.gov ID: NCT07752407
What this study is testing
What is Vonoprazan?
This is an investigational oral tablet being studied to see if it helps relieve heartburn in people with non-erosive gastroesophageal reflux disease. It is designed to reduce the amount of acid produced in the stomach.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study will see if vonoprazan helps stop heartburn episodes and stays safe over time.
- Who it's for
- Adults who have frequent heartburn but no visible damage in their esophagus.
- What's involved
- Participants will take 10 mg vonoprazan or a placebo as needed, attend clinic visits, and have routine safety checks.
- Time commitment
- The study lasts about 24 weeks, with regular visits to monitor symptoms and safety.
- Phase 3: a large, late-stage study
- Time commitment: about 12 weeks
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- The participant has a diagnosis of non-erosive GERD with heartburn as the participant's predominant symptom prior to the Screening Period as...
- History of onset of heartburn at least 6 months prior to the Screening Period.
You likely can't join if
- The participant has endoscopically confirmed erosive esophagitis (EE) during the Screening Period or was diagnosed with EE within 2 weeks prior to...
- The participant has uncontrolled irritable bowel syndrome (IBS) or has had a flare of IBS requiring therapy within the prior 6 months.
- Functional heartburn, as described in the Rome V criteria.
- Functional dyspepsia, as described in the Rome V criteria.
- The participant has endoscopic Barrett's esophagus (\>1 cm of columnar-lined esophagus) and/or definite dysplastic changes in the esophagus.
- The participant tests positive for H. pylori infection during the Screening Period, after ≥ 4 weeks free from antibiotics and bismuth and ≥ 2 weeks...
See the full eligibility criteria
Who can 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, 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 has a diagnosis of non-erosive GERD with heartburn as the participant's predominant symptom prior to the Screening Period as documented in the medical history and/or as assessed and documented by the...
- History of onset of heartburn at least 6 months prior to the Screening Period.
- Heartburn reported on average 4 or more days per week and 4 or more days during the last 7 days of the Screening Period as recorded in the electronic diary.
- 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 on the last 7 days of the Run-In Period.
- The participant continues to fulfill all eligibility criteria for the Run-In Period except heartburn reported on average 4 or more days per week and 4 or more days during the last 7 days of the Screening Period as...
- Participant completes at least 80% of diary entries during the Run-In Period and completes at least 6 of 7 (86%) diary entries over the last 7 days of the Run-In Period.
What rules you out
- The participant has endoscopically confirmed erosive esophagitis (EE) during the Screening Period or was diagnosed with EE within 2 weeks prior to the Screening Period.
- The participant has uncontrolled irritable bowel syndrome (IBS) or has had a flare of IBS requiring therapy within the prior 6 months.
- Functional heartburn, as described in the Rome V criteria.
- Functional dyspepsia, as described in the Rome V criteria.
- The participant has endoscopic Barrett's esophagus (\>1 cm of columnar-lined esophagus) and/or definite dysplastic changes in the esophagus.
- The participant tests positive for H. pylori infection during the Screening Period, after ≥ 4 weeks free from antibiotics and bismuth and ≥ 2 weeks free from proton pump inhibitors (PPIs), potassium-competitive acid...
- The participant has any other clinically significant condition affecting the esophagus, including eosinophilic esophagitis; esophageal varices; viral or fungal infection; esophageal stricture
- 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...
- The participant has had gastric or duodenal ulcer(s) within 4 weeks before the first dose of study drug.
- The participant requires or is expected to require use of prescription or non-prescription PPIs, PCABs, or 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 has ever received vonoprazan in a clinical trial...
- 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...
- 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...
- 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...
- 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, metabolic, other gastrointestinal, urological, endocrine, or hematological disease that, in the...
- 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 Period.
- The participant has a history of malignancy (including mucosa-associated lymphoid tissue lymphoma) or has been treated for malignancy within 5 years prior to the start of the Screening Period (Visit 1).
- The participant has acquired immunodeficiency syndrome or human immunodeficiency virus (HIV) infection, or tests positive for the hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or HCV-ribonucleic...
- The participant has moderate to severe hepatic impairment [Child-Pugh Class B and Child-Pugh Class C].
- The participant has severe renal impairment [estimated glomerular filtration rate \<30 mL/min]).
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>2 × the upper limit of normal (ULN) or total bilirubin \>2 × ULN (except participants with Gilbert Syndrome).
- Creatinine levels: \>2 mg/dL (\>177 μmol/L).
The study team makes the final eligibility decision.
Where it is enrolling
- Mentor, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The study runs about 12 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Mentor, Ohio, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.