Gastroesophageal Reflux Disease (GERD)ARMORNCT06984484
Performance and Safety of Afluxin® in Patients With Gastroesophageal Reflux Disease
A study testing Afluxin® in people with Gastroesophageal Reflux Disease (GERD), run by Devintec Sagl at 7 sites in Italy.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastroesophageal Reflux Disease (GERD)
- What is being tested?
- Afluxin®
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 208 participants
- Where
- 7 sitesItaly
- Study dates
- 2 Jul 2025to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 least 7 days before starting the treatment, as assessed on a clinical basis by the Investigator.
- 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.
- 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 effective contraceptive method for the individual subject and her partner(s) throughout the study treatment period.
Who cannot join
- 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, 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.
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- 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.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
Italy7 sites, 7 recruiting
- Recruiting
IRCCS Policlinico San Martino
Genova, 16132
Elisa Marabotto
- Recruiting
IRCCS Ca' Granda Ospedale Maggiore Policlinico Foundation
Milan, 20122
Marina Coletta
- Recruiting
AOU Federico II di Napoli
Naples, 80131
Giovanni Sarnelli
- Recruiting
Azienda Ospedale Università Padova
Padova, 35128
Edoardo Vincenzo Savarino
- Recruiting
S. Andrea Ospedale Universitario
Roma, 00189
Bruno Annibale
- Recruiting
Humanitas Research Hospital
Rozzano (MI), 20089
Roberta Maselli
- Recruiting
A.O.U. Città della Salute e della Scienza di Torino
Torino, 10126
Davide Giuseppe Ribaldone
About this study
Official title: 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)
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). Common symptoms include heartburn and acid regurgitation. Lifestyle factors such as smoking, obesity, and Helicobacter pylori infection can increase the risk of developing GERD. The clinical management of GERD typically involves Proton Pump Inhibitors (PPIs) therapy, which, although effective, may not benefit all patients and can be associated with long-term risks. The American College of Gastroenterology (ACG) suggests PPIs discontinuation or on-demand therapy for uncomplicated GERD after an 8-week trial. However, evidence indicates that PPIs are used more frequently, often long-term and in high doses, and not necessarily according to recommendations. Moreover, the availability of Over-The-Counter (OTC) PPIs has led to prolonged use by patients without medical guidance. Concerns have been raised due to potential side effects of long-term PPIs use, including enteric, respiratory, and urinary tract infections, as well as an increased risk of vitamin and mineral deficiencies and osteoporosis.
Alternatives to PPIs include Histamine-2 Receptor Antagonists (H2RAs), antacids and alginate-based formulations. Among OTC treatments, medical devices formulated with natural components are also gaining attention for their potential performance and tolerability in managing mild to moderate GERD symptoms. These alternatives could address the unmet needs of NERD patients, especially those with a low response to PPIs treatment and provide an option without the potential side effects of prolonged PPIs use. Afluxin® is a class III medical device, containing functional substances (tamarind seed polysaccharide, pea protein and polyacrylic acid), formulated for the treatment of mild to moderate GERD. Preclinical data have shown that Afluxin® is able to create a protective barrier over the gastroesophageal epithelium, preventing reflux damage. In vitro studies suggest that Afluxin® effectively binds to the esophageal and gastric mucosa, reducing abnormal permeability caused by acid reflux. Moreover, in vivo evidence shows that Afluxin® can increase gastric pH, reduce epigastric pain, esophageal damage, and inflammatory markers associated with GERD. Given the encouraging results obtained in preclinical investigations, this study is designed to provide clinical evidence to support the performance and safety of Afluxin® in reducing gastrointestinal symptoms of patients with mild to moderate GERD in a multicenter, randomized, double-blind, parallel-group, Afluxin® stick pack vs. inactive control clinical investigation.
- Conditions
- Gastroesophageal Reflux Disease (GERD)
- Being tested
- Afluxin®, Placebo
- Keywords
- Gastroesophageal Reflux Disease, GERD, Afluxin
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Afluxin®Device
Afluxin® stick pack is an oral suspension to be taken without any liquid 3 times a day after breakfast, lunch and before going to bed, for 7 days.
PlaceboDrug
Inactive control stick pack is an oral suspension to be taken without any liquid 3 times a day after breakfast, lunch and before going to bed, for 7 days.
| Study group | Role | What they receive |
|---|---|---|
| Afluxin® | Experimental | Afluxin® is a medical device not CE marked yet. According to the Annex VIII of MDR 2017/745 it belongs to class III (Rule 21). Afluxin® stick pack is an oral suspension to be taken without any liquid 3 times a day after breakfast, lunch and before going to bed.
Afluxin® does not contain any medicinal substances, human or animal tissues or their derivatives, or other biologically active substances coming in contact with the patient.
The composition of one stick pack of Afluxin® is the following: purified water, isolated pea proteins, tamarind seed polysaccharide (Tamarindus indica L.), polyacrylic acid, propyl 4-hydroxybenzoate sodium salt, sodium methylparaben, strawberry aroma, mint aroma, sodium hydroxide, sucralose. Receives: Device: Afluxin® |
| Placebo | Placebo comparator | Placebo is an inactive preparation designed to match the active treatment in taste and have a similar color (white-transparent) to Afluxin®. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the superiority of a 7-day treatment course with Afluxin® over inactive control in terms of difference between treatment groups in terms of proportion of responders
The primary endpoint is the difference between treatment groups (Afluxin® and placebo) in terms of proportion of responders, defined as patients who report a reduction in the GERD dimension of the RDQ (Reflux Disease Questionnaire) equal to 1.5 points (clinically significant difference, according to Wilkinson et al., 2019), between baseline and the end of the 7-day treatment.
In the RDQ questionnaire validated in Italian language, patients are asked to rate GERD-related symptoms they have been experiencing over the past 7 days. The questionnaire consists of 12 items to report the frequency and severity of heartburn, regurgitation and dyspepsia. In this study the two subscales for heartburn and regurgitation will be combined into the GERD dimension. Symptom frequency and severity will be measured on 6-point scales (ranging from 0=none to 5 =daily/severe).
Measured: From enrollment to the end of the 7-day treatment
Secondary outcomes (13)
RDQ GERD dimension, including single item scores
GERD dimension evaluated through the RDQ (Reflux Disease Questionnaire) and evaluation of the single item scores, at the baseline and at the end of the 7-day treatment.
In the RDQ questionnaire validated in Italian language, patients are asked to rate GERD-related symptoms they have been experiencing over the past 7 days. The self-assessed questionnaire will consist of 12 items to report the frequency and severity of heartburn, regurgitation and dyspepsia. The two subscales for heartburn and regurgitation will be combined into the GERD dimension. Symptom frequency and severity will be measured on 6-point scales (ranging from 0=none to 5 =daily/severe).
Measured: Baseline and at the end of the 7-day treatment
RDQ dyspepsia dimension total and single item scores
Dyspepsia dimension evaluated through the RDQ (Reflux Disease Questionnaire) total and single item scores, at the baseline and at the end of the 7-day treatment.
In the RDQ questionnaire validated in Italian language, patients are asked to rate GERD-related symptoms they have been experiencing over the past 7 days. The self-assessed questionnaire will consist of 12 items to report the frequency and severity of heartburn, regurgitation and dyspepsia (burning/pain in the upper stomach). Symptom frequency and severity will be measured on 6-point scales (ranging from 0=none to 5 =daily/severe).
Measured: Baseline and at the end of the 7-day treatment
Total and single item scores of the Reflux Symptom Index (RSI)
Total and single item scores of the Reflux Symptom Index (RSI) at baseline and at the end of the 7-day treatment, assessing the severity of Laryngopharyngeal Reflux (LPR) symptoms.
The RSI validated in Italian language, will be used for the evaluation of LPR symptoms that patients have been experiencing within the last month. The RSI examines 9 items, to be scored from 0 (no problem) to 5 (severe problem), with a higher score indicating a higher severity of the symptom (range of total score: 0-45) .
Measured: Baseline and at the end of the 7-day treatment
Severity of GERD cardinal symptoms (i.e., heartburn and regurgitation)
Severity of GERD cardinal symptoms (i.e., heartburn and regurgitation) throughout the 7-day treatment, as self-assessed daily by patients using a 7-point Likert scale ranging from 1 = no discomfort to 7 = very severe discomfort.
Measured: Throughout the 7-day treatment
Severity of LPR symptoms (i.e., hoarseness/clearing the throat and troublesome cough)
Severity of (Laryngopharyngeal Reflux) LPR symptoms (i.e., hoarseness/clearing the throat and troublesome cough) throughout the 7-day treatment, as self-assessed daily by patients using a 7-point Likert scale ranging from 1 = no discomfort to 7 = very severe discomfort.
Measured: Throughout the 7-day treatment
Number and percentage of patients with occurrence of symptoms during the night
Number and percentage of patients with occurrence of symptoms during the night throughout the 7-day treatment
Measured: Throughout the 7-day treatment
Mean time to alleviation of symptoms following treatment administration
Mean time to alleviation of symptoms following treatment administration throughout the 7-day treatment, as self-assessed daily by patients
Measured: Throughout the 7-day treatment
Number and percentage of patients with complete remission of symptoms
Number and percentage of patients with complete remission of symptoms at the end of the 7-day treatment, defined as an RDQ (Reflux Disease Questionnaire) GERD dimension total score = 0 points.
In the RDQ questionnaire validated in Italian language, patients are asked to rate GERD-related symptoms they have been experiencing over the past 7 days. The self-assessed questionnaire will consist of 12 items to report the frequency and severity of heartburn, regurgitation and dyspepsia. Symptom frequency and severity will be measured on 6-point scales (ranging from 0=none to 5 =daily/severe).
Measured: At the end of the 7-day treatment
Mean score on the self-report measure Patient's Global Impression of Change (PGI-C)
Mean score on the self-report measure Patient's Global Impression of Change (PGI-C) at the end of the 7-day treatment, assessing the patient's overall perceived change in their condition.
The self-report measure PGI-C will be used to assess the overall perceived improvement at the end of the 7-day treatment. Patients will reply to the general statement "Since the start of the study, my overall status is'", using the following 7-point scale: 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, and 7=very much worse.
Measured: At the end of the 7-day treatment
Number and percentage of patients who take prohibited medications
Number and percentage of patients who take prohibited medications (Proton Pump Inhibitors, Histamine-2 Receptor Antagonists, antiacid, alginates or medical devices made of substances).
Measured: Throughout the 7-day treatment
Patient's compliance with treatment
Patient's compliance with treatment protocol, in terms of adherence to the instructions and recommendations of the study treatment protocol. The information are recorded on the patient's diary and reviewed by the investigators. Patient differences in % compliance between the two treatments will be calculated.
Measured: Throughout the 7-day treatment
Patient's satisfaction with treatment
Patient's satisfaction with treatment, as self-assessed by the patient using a 5-point response scale, at the end of the 7-day treatment.
At the end of the 7-day treatment the patient will record his/her opinion of satisfaction with treatment in the e-diary, answering the question: "How satisfied are you with the study treatment you received?" with a 5-point response scale (1=unsatisfied, 2=somewhat unsatisfied, 3=neutral, 4=somewhat satisfied, 5=satisfied).
Measured: At the end of the 7-day treatment
Safety: adverse events and device deficiencies
Incidence and type of AEs and DDs continuously monitored during the study
Measured: Throughout the 7-day treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2025
- Study start2 Jul 2025
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroesophageal Reflux Disease (GERD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 208 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Devintec Sagl
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06984484
- Sponsor's protocol ID
- DVT2024-3
- Acronym
- ARMOR
- Status last verified
- Aug 2026
- First submitted
- 14 May 2025
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT06984484
- Acronym / sponsor ID
- ARMOR / DVT2024-3
- Conditions
- Gastroesophageal Reflux Disease (GERD)
- Keywords
- Gastroesophageal Reflux Disease, GERD, Afluxin
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 208 participants (estimated)
- Lead sponsor
- Devintec SaglIndustry (pharma, biotech, devices)
- Study start
- 2 Jul 2025 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 22 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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). Common symptoms include heartburn and acid regurgitation. Lifestyle factors such as smoking, obesity, and Helicobacter pylori infection can increase the risk of developing GERD. The clinical management of GERD typically involves Proton Pump Inhibitors (PPIs) therapy, which, although effective, may not benefit all patients and can be associated with long-term risks. The American College of Gastroenterology (ACG) suggests PPIs discontinuation or on-demand therapy for uncomplicated GERD after an 8-week trial. However, evidence indicates that PPIs are used more frequently, often long-term and in high doses, and not necessarily according to recommendations. Moreover, the availability of Over-The-Counter (OTC) PPIs has led to prolonged use by patients without medical guidance. Concerns have been raised due to potential side effects of long-term PPIs use, including enteric, respiratory, and urinary tract infections, as well as an increased risk of vitamin and mineral deficiencies and osteoporosis.
Alternatives to PPIs include Histamine-2 Receptor Antagonists (H2RAs), antacids and alginate-based formulations. Among OTC treatments, medical devices formulated with natural components are also gaining attention for their potential performance and tolerability in managing mild to moderate GERD symptoms. These alternatives could address the unmet needs of NERD patients, especially those with a low response to PPIs treatment and provide an option without the potential side effects of prolonged PPIs use. Afluxin® is a class III medical device, containing functional substances (tamarind seed polysaccharide, pea protein and polyacrylic acid), formulated for the treatment of mild to moderate GERD. Preclinical data have shown that Afluxin® is able to create a protective barrier over the gastroesophageal epithelium, preventing reflux damage. In vitro studies suggest that Afluxin® effectively binds to the esophageal and gastric mucosa, reducing abnormal permeability caused by acid reflux. Moreover, in vivo evidence shows that Afluxin® can increase gastric pH, reduce epigastric pain, esophageal damage, and inflammatory markers associated with GERD. Given the encouraging results obtained in preclinical investigations, this study is designed to provide clinical evidence to support the performance and safety of Afluxin® in reducing gastrointestinal symptoms of patients with mild to moderate GERD in a multicenter, randomized, double-blind, parallel-group, Afluxin® stick pack vs. inactive control clinical investigation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Afluxin® | Experimental | Device: Afluxin®Afluxin® is a medical device not CE marked yet. According to the Annex VIII of MDR 2017/745 it belongs to class III (Rule 21). Afluxin® stick pack is an oral suspension to be taken without any liquid 3 times a day after breakfast, lunch and before going to bed. Afluxin® does not contain any medicinal substances, human or animal tissues or their derivatives, or other biologically active substances coming in contact with the patient. The composition of one stick pack of Afluxin® is the following: purified water, isolated pea proteins, tamarind seed polysaccharide (Tamarindus indica L.), polyacrylic acid, propyl 4-hydroxybenzoate sodium salt, sodium methylparaben, strawberry aroma, mint aroma, sodium hydroxide, sucralose. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo is an inactive preparation designed to match the active treatment in taste and have a similar color (white-transparent) to Afluxin®. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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 least 7 days before starting the treatment, as assessed on a clinical basis by the Investigator.
- 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.
- 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.
Key exclusion criteria (16 listed)
- Patient with hypersensitivity to any Afluxin® or inactive control components.
- Rhinosinusitis or bronchitis.
- Patients with a:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Afluxin®Afluxin® stick pack is an oral suspension to be taken without any liquid 3 times a day after breakfast, lunch and before going to bed, for 7 days. | Device | Afluxin® |
| PlaceboInactive control stick pack is an oral suspension to be taken without any liquid 3 times a day after breakfast, lunch and before going to bed, for 7 days. | Drug | Placebo |
Primary outcome
Assess the superiority of a 7-day treatment course with Afluxin® over inactive control in terms of difference between treatment groups in terms of proportion of responders
Time frame: From enrollment to the end of the 7-day treatment
The primary endpoint is the difference between treatment groups (Afluxin® and placebo) in terms of proportion of responders, defined as patients who report a reduction in the GERD dimension of the RDQ (Reflux Disease Questionnaire) equal to 1.5 points (clinically significant difference, according to Wilkinson et al., 2019), between baseline and the end of the 7-day treatment. In the RDQ questionnaire validated in Italian language, patients are asked to rate GERD-related symptoms they have been experiencing over the past 7 days. The questionnaire consists of 12 items to report the frequency and severity of heartburn, regurgitation and dyspepsia. In this study the two subscales for heartburn and regurgitation will be combined into the GERD dimension. Symptom frequency and severity will be measured on 6-point scales (ranging from 0=none to 5 =daily/severe).
13 secondary outcomes
RDQ GERD dimension, including single item scores
Time frame: Baseline and at the end of the 7-day treatment
RDQ dyspepsia dimension total and single item scores
Time frame: Baseline and at the end of the 7-day treatment
Total and single item scores of the Reflux Symptom Index (RSI)
Time frame: Baseline and at the end of the 7-day treatment
Severity of GERD cardinal symptoms (i.e., heartburn and regurgitation)
Time frame: Throughout the 7-day treatment
Severity of LPR symptoms (i.e., hoarseness/clearing the throat and troublesome cough)
Time frame: Throughout the 7-day treatment
Number and percentage of patients with occurrence of symptoms during the night
Time frame: Throughout the 7-day treatment
Mean time to alleviation of symptoms following treatment administration
Time frame: Throughout the 7-day treatment
Number and percentage of patients with complete remission of symptoms
Time frame: At the end of the 7-day treatment
Mean score on the self-report measure Patient's Global Impression of Change (PGI-C)
Time frame: At the end of the 7-day treatment
Number and percentage of patients who take prohibited medications
Time frame: Throughout the 7-day treatment
Patient's compliance with treatment
Time frame: Throughout the 7-day treatment
Patient's satisfaction with treatment
Time frame: At the end of the 7-day treatment
Safety: adverse events and device deficiencies
Time frame: Throughout the 7-day treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Afluxin® in people with Gastroesophageal Reflux Disease (GERD), run by Devintec Sagl at 7 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daniela Salvati (+39 3334828012, daniela.salvati@prineos.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess the superiority of a 7-day treatment course with Afluxin® over inactive control in terms of difference between treatment groups in terms of proportion of responders (time frame: From enrollment to the end of the 7-day treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.