This study focuses on individuals who have healed erosive esophagitis, which is an inflammation and damage to the lining of the esophagus caused by gastroesophageal reflux disease, a condition where stomach acid flows back up into the food pipe. The purpose of the study is to evaluate the effectiveness and safety of a new medication called linaprazan glurate compared to an existing medication called lansoprazole in keeping the esophagus healed.
Participants in the study will be assigned to receive either linaprazan glurate or lansoprazole. Because the study uses a double-dummy method to ensure that neither the researchers nor the participants know which medication is being taken, some individuals will receive combinations of the active medication and a placebo. The treatment involves taking tablets by oral use over a period of time to see how well the esophagus remains healed and to monitor any potential side effects.
Who Can Join the Study?
You must be able to understand and voluntarily sign an Informed Consent Form, which is a document that explains all the details of the study before you agree to join.
You must have had erosive esophagitis (which means sores or inflammation in the tube that carries food from your throat to your stomach) that has successfully healed.
The healing of your condition must have been confirmed by an endoscopic examination, which is a medical procedure where a doctor uses a tiny camera on a flexible tube to look inside your esophagus.
You must be willing and able to follow all the rules of the study, such as undergoing endoscopies, swallowing pills or capsules, and using an electronic device to record information.
You must have previously participated in a study testing linaprazan glurate for healing your condition.
The study is open to both males and females.
Participants must fall within the specific age range required for this study.
Who Cannot Join the Study?
People who have already participated in this specific study before.
People who did not follow the study rules or treatment correctly during a previous phase of this research.
People who had to stop taking the study medicine early in a previous phase due to an adverse event, which is an unwanted or harmful medical occurrence.
People with a single esophageal ulcer, which is a sore in the tube that carries food from your throat to your stomach, located in the upper part of that tube.
People with untreated Barrett’s esophagus, a condition where the lining of the food pipe changes due to long-term acid reflux.
People with any other condition affecting the food pipe, such as eosinophilic esophagitis (a type of inflammation caused by a specific type of white blood cell), esophageal varices (swollen veins in the food pipe), viral or fungal infections, or an esophageal stricture (a narrowing of the food pipe).
People with a history of current or recent use of alcohol, drugs, or androgens, which are natural substances like testosterone that act as male sex hormones, within the last 2 years.
Women who are currently pregnant or breastfeeding.
Women who are able to become pregnant and are sexually active but are unwilling to use highly effective contraception, which refers to methods used to prevent pregnancy, from the start of the study until 7 days after the last dose of medicine.
Men who have a partner able to become pregnant and are unwilling to use highly effective pregnancy prevention methods or agree not to father a child during the study period.
People who work for the study researchers, the company running the trial, or the organization managing the study, including their family members.
People with significant health problems in their cardiovascular (heart and blood vessels), respiratory (breathing), hepatic (liver), renal (kidney), gastrointestinal (stomach and intestines), endocrine (hormones), hematological (blood), neurological (brain and nerves), or psychiatric (mental health) systems that could make the study unsafe or affect the results.
People with a history of a myocardial infarction, which is the medical term for a heart attack, within the last 3 months.
People with a history of ventricular arrhythmia, which is an irregular heartbeat starting in the lower chambers of the heart, or those who have an implanted cardioverter defibrillator, a device placed in the chest to control heart rhythms.
People with congestive heart failure, a condition where the heart does not pump blood as well as it should.
People with a family history or diagnosis of hereditary arrhythmia syndrome, which are heart rhythm problems passed down through families.
People with a history of adult asthma that was severe enough to require emergency room treatment.
People planning any major surgery within one year of the study starting.
People with abnormal blood test results, specifically high levels of ALT or AST (liver enzymes that show liver health) or high total bilirubin (a substance made during the breakdown of red blood cells), unless they have Gilbert’s syndrome, a common and harmless liver condition.
People who are currently participating in a different medical study, unless it is a specific healing study for the same condition using the same medicine.
Linaprazan glurate is the experimental medication being tested in this study. It is an oral tablet used to help maintain the healing of the esophagus in people who have had damage caused by acid reflux.
Lansoprazole is a medication used as a comparison in this trial. It is an oral medicine commonly used to reduce the amount of acid produced in the stomach to help treat and maintain healing in the esophagus.
Erosive esophagitis – This condition occurs when stomach acid flows back into the tube connecting your mouth and stomach. This backflow causes irritation and leads to the formation of open sores or erosions on the lining of the esophagus. As the condition progresses, these sores can become more severe and widespread along the esophageal wall. The repeated exposure to acid can cause inflammation and damage to the tissue.
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