Phase 3 Gastro-oesophageal Reflux Disease Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who are willing to read and sign a consent form before any study activities begin.
• People aged 18 to 80 years old at the time of signing the consent form.
• People who are able and willing to follow all parts of the study, including attending camera examinations of the stomach (endoscopies), giving blood samples, swallowing tablets and capsules, and completing tasks on an electronic device.
• People who have been confirmed, through a camera examination of the food pipe (endoscopy) during the screening period, to have erosive esophagitis (inflammation and sores in the food pipe) caused by acid reflux, graded A through D on a standard medical scale.

Who may not be able to join:

• People who currently have an active H. pylori stomach infection, or who were diagnosed and treated for one within 6 weeks before being enrolled in the study, or who have taken antibiotics or bismuth-containing medicines within 6 weeks before enrolment.
• People with a significant medical history or current condition involving the heart, lungs, liver, kidneys, digestive system, hormones, blood, nervous system, or mental health, if the treating doctor considers this a concern — including people who have had a heart attack or acute coronary event within the past 3 months, a history of dangerous heart rhythm problems or an implanted heart device, severe heart failure, a family or personal history of inherited heart rhythm conditions, or adult asthma that has required emergency treatment.
• People who have had cancer of any organ in the past 5 years, with the exception of certain fully treated, non-spreading skin cancers or treated cervical carcinoma in place (confirm with trial site).
• People with certain conditions affecting the food pipe (esophagus), including an isolated ulcer in the upper portion of the food pipe, untreated Barrett's esophagus, eosinophilic esophagitis, varicose veins in the food pipe, viral or fungal infection there, narrowing of the food pipe, or a history of certain medical procedures or chemical injury to the food pipe. People with a Schatzki's ring (a band of tissue at the lower end of the food pipe) may still be considered, unless that ring was stretched/treated within 3 months before screening (confirm with trial site).
• People who have had major surgery or medical conditions that could significantly change their acid reflux disease or affect how the body processes medicines — such as removal of part of the stomach, weight-loss surgery, bowel removal surgery, or certain liver procedures. A previous Nissen fundoplication procedure is not automatically disqualifying (confirm with trial site).
• People known to have severe thinning and damage of the stomach lining (severe atrophic gastritis), identified from their medical history or the screening endoscopy.
• People with Zollinger-Ellison syndrome or other conditions that cause the stomach to produce too much acid.
• People who have taken the acid-reducing medicine lansoprazole within 2 months before screening.
• People who currently have a peptic ulcer (an open sore in the stomach or upper digestive tract).
• People whose body mass index (a measure of body weight relative to height) is 18 or below, or 40 or above, at the time of screening.

Important: Always verify eligibility with the trial site directly before applying.