Afluxin® for adults with gastroesophageal reflux disease (GERD)

A Multicenter, RandoMized, Double-blind, Parallel-grOup, Afluxin® Stick Pack vs. Inactive contRol Clinical Investigation to Evaluate the Performance and Safety in Patients With Gastroesophageal Reflux Disease (GERD)

This trial will test whether Afluxin® reduces heartburn and acid regurgitation in adults with GERD who are not currently using PPIs or other acid-suppressing treatments.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 208 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Devintec Sagl (Industry-sponsored)
• Locations: 7 sites (Genova and 6 other locations)
• Trial ID: NCT06984484 on ClinicalTrials.gov

What this trial studies

This interventional study will give enrolled adults with symptomatic GERD either Afluxin® or a placebo and monitor symptom changes and safety outcomes. Eligible participants are aged 18–75 and must not have used PPIs, H2RAs, antacids, alginates, or substance-based GERD devices in the week before screening. The trial will collect clinical symptom data and safety information while participants are treated at participating centers. Study visits are being conducted at multiple university-affiliated hospitals in Italy.

Who should consider this trial

Good fit: Adults aged 18–75 with ongoing heartburn or regurgitation who have not used PPIs, H2RAs, antacids, alginates, or similar substance-based devices in the week before screening are ideal candidates.

Not a fit: People on chronic or recent PPI therapy, those with complicated or severe GERD requiring long-term acid suppression, or patients outside the 18–75 age range may be unlikely to benefit from this trial.

Why it matters

Potential benefit: If successful, Afluxin® could offer an effective non-PPI option to reduce GERD symptoms and help limit long-term PPI use for some patients.

How similar studies have performed: Proton pump inhibitors are a well-established GERD treatment, while Afluxin® represents a relatively novel non-PPI approach with limited published clinical trial data to date.

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.

Where this trial is running

Genova and 6 other locations

• IRCCS Policlinico San Martino — Genova, Italy (Recruiting)
• IRCCS Ca' Granda Ospedale Maggiore Policlinico Foundation — Milan, Italy (Recruiting)
• AOU Federico II di Napoli — Naples, Italy (Recruiting)
• Azienda Ospedale Università Padova — Padova, Italy (Recruiting)
• S. Andrea Ospedale Universitario — Roma, Italy (Recruiting)
• Humanitas Research Hospital — Rozzano (MI), Italy (Recruiting)
• A.O.U. Città della Salute e della Scienza di Torino — Torino, Italy (Recruiting)

Study contacts

• Study coordinator: Daniela Salvati

Conditions Gastroesophageal Reflux Disease; GERD; Afluxin