Performance and Safety of Afluxin® in Patients With Gastroesophageal Reflux Disease

Launched by DEVINTEC SAGL · May 21, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment called Afluxin® for people with Gastroesophageal Reflux Disease (GERD), a condition where stomach acid flows back into the esophagus, causing discomfort like heartburn. Afluxin® is a medical device made from natural ingredients that aims to create a protective barrier in the esophagus, potentially reducing symptoms and damage caused by acid reflux. The study will compare Afluxin® to a placebo (an inactive version) to see how well it works and how safe it is for patients experiencing mild to moderate GERD symptoms.

To participate in this trial, individuals must be between 18 and 75 years old and have been experiencing symptoms of GERD, such as heartburn or regurgitation, for at least a week. Participants should not have taken certain medications like proton pump inhibitors (PPIs) or other treatments for GERD recently. During the trial, participants will receive either Afluxin® or the placebo and will be monitored for their symptoms and any potential side effects. It’s important for potential participants to understand the study procedures and provide informed consent before joining.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Male and female patients, aged ≥ 18 years and ≤ 75 years.
• • 2. Evidence of symptomatic GERD: patients with ongoing heartburn and/or regurgitation (with or without dyspepsia symptoms of epigastric pain and/or burning) of at least mild to moderate severity or experienced during the least 7 days before starting the treatment, as assessed on a clinical basis by the Investigator.
• • 3. Patients not pre-treated with PPIs, even for problems different from GERD (e.g., gastroprotection, PPI-based triple or quadruple therapy for eradication of H. pylori), H2RAs, and/or with antiacids, alginates or medical devices made of substances (i.e., substance-based medical devices to treat GERD, gastroesophageal reflux and similar conditions) in the last week prior to screening.
• • 4. Patient has provided written informed consent after being informed of the study procedures and risks prior to any study-related events.
• • 5. Patients are able to understand and adhere to the study procedures.
• • 6. Females of childbearing potential must have a negative urine pregnancy test (dipstick) at Visit 1 and currently use or agree to use consistently and correctly (i.e., perfect use) a highly effective or acceptable effective contraceptive method for the individual subject and her partner(s) throughout the study treatment period.
• Exclusion Criteria:
• • 1. Patient with hypersensitivity to any Afluxin® or inactive control components.
• • 2. Rhinosinusitis or bronchitis.
• 3. Patients with a:
• • 1. history and/or
• • 2. symptom profile and/or
• • 3. discovered on endoscopy suggestive of the following: any other Gastrointestinal (GI) disease, erosive GERD, BE, acute peptic ulcer and/or ulcer complications, hiatus hernia with a diameter which exceeds 3 cm, Zollinger-Ellison syndrome, esophageal or gastric cancer, pyloric stenosis, esophageal or gastric surgery, intestinal obstruction, current pernicious anemia, indication for H. pylori eradication therapy, known gastro-intestinal bleeding (hematochezia or hematemesis) within the last 12 months.
• • 4. Patients diagnosed with functional dyspepsia characterized by postprandial distress syndrome (i.e., bothersome postprandial fullness and/or early satiation).
• • 5. Patients with a history of gastro-esophageal surgery, anti-reflux, or bariatric procedure.
• • 6. Presence of any active malignancy (except for non-invasive basal or squamous cell carcinoma of the skin).
• 7. Patients using any drug that could affect symptoms or affecting the gastrointestinal tract during the last week prior to screening:
• • 1. prokinetics
• • 2. systemic glucocorticosteroids
• • 3. Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
• • 8. Patients who are pregnant or lactating.
• • 9. Patients who are enrolled in or have participated in other clinical trials or investigations within 30 days prior to screening.
• • 10. Clinically significant or unstable concurrent diseases whose sequelae or treatment might contraindicate study participation or interfere with the study evaluation parameters, as judged by the Investigator.