BridgeMD
Tests treatment safety and results for Gastroesophageal Reflux Disease (GERD)
Official title Performance and Safety of Afluxin® in Patients With Gastroesophageal Reflux Disease
ClinicalTrials.gov ID: NCT06984484
What this study is testing
- What it's testing
- Gastroesophageal Reflux Disease (GERD) is a chronic condition in which stomach acid flows back into the esophagus, causing irritation and inflammation. GERD is categorized into Nonerosive Reflux Disease (NERD), Erosive Esophagitis (EE), and Barrett's esophagus (BE).
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Male and female patients, aged ≥ 18 years and ≤ 75 years.
- Evidence of symptomatic GERD: patients with ongoing heartburn and/or regurgitation (with or without dyspepsia symptoms of epigastric pain and/or...
- Patients not pre-treated with PPIs, even for problems different from GERD (e.g., gastroprotection, PPI-based triple or quadruple therapy for...
- Patient has provided written informed consent after being informed of the study procedures and risks prior to any study-related events.
- Patients are able to understand and adhere to the study procedures.
You likely can't join if
- Patient with hypersensitivity to any Afluxin® or inactive control components.
- Rhinosinusitis or bronchitis.
- Patients with a:
- history and/or
- symptom profile and/or
- discovered on endoscopy suggestive of the following: any other Gastrointestinal (GI) disease, erosive GERD, BE, acute peptic ulcer and/or ulcer...
See the full eligibility criteria
- Male and female patients, aged ≥ 18 years and ≤ 75 years.
- 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...
- 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...
- Patient has provided written informed consent after being informed of the study procedures and risks prior to any study-related events.
- Patients are able to understand and adhere to the study procedures.
- 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...
- Patient with hypersensitivity to any Afluxin® or inactive control components.
- Rhinosinusitis or bronchitis.
- Patients with a:
- history and/or
- symptom profile and/or
- 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...
- Patients diagnosed with functional dyspepsia characterized by postprandial distress syndrome (i.e., bothersome postprandial fullness and/or early satiation).
- Patients with a history of gastro-esophageal surgery, anti-reflux, or bariatric procedure.
- Presence of any active malignancy (except for non-invasive basal or squamous cell carcinoma of the skin).
- Patients using any drug that could affect symptoms or affecting the gastrointestinal tract during the last week prior to screening:
- prokinetics
- systemic glucocorticosteroids
- Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
- Patients who are pregnant or lactating.
- Patients who are enrolled in or have participated in other clinical trials or investigations within 30 days prior to screening.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Genova, Italy
- Milan, Italy
- Naples, Italy
- Padova, Italy
- Roma, Italy
- Rozzano (MI), Italy
- Torino, Italy
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 - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Genova, Italy; Milan, Italy; Naples, Italy; Padova, Italy; Roma, Italy; Rozzano (MI), Italy and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.