Gastroesophageal Reflux (GERD), GERD (Heartburn, Regurgitation, and Dyspepsia)
Conditions
Keywords
GastroEsophageal Reflux GERD
Brief summary
This study involves a medical device in the form of syrup, not yet on the market and tested for the first time in humans, named "FIBROIN SYRUP". The intended use is to reduce the GastroEsophageal Reflux Disease (GERD) symptoms such as heartburn, epigastric pain, irritative and nocturnal cough, dysphagia and dysphonia, which may occur especially after meals or during the night due to lying position. "FIBROIN SYRUP" has never been tested on humans and this study aims to evaluate the safety, tolerability and efficacy of the medical device when taken after the main meals (breakfast, lunch, and dinner; total: 3 sticks/day) for 6 weeks.
Detailed description
This study requires 4 outpatient visits in 6 weeks and it is addressed to patients over 18 years old suffering from heartburn and/or regurgitation for at least 8 weeks
Interventions
DEVICESyrup made by hyaluronic acid
Syrup made by hyaluronic acid that forms a protective layer that adheres to the esophageal mucosa and has a mechanical action
Sponsors
Rose Pharma SA
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Medical device under form of syrup with a mechanical action
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient who signed Informed consent form; * Male or Female over 18 years old at the time of the signature of the Informed consent form; * Symptomatic non-erosive reflux disease (heartburn and/or regurgitation) for at least 8 weeks; * RDQ (Reflux Disease Questionnaire) score ≥ 12 at baseline (questionnaire specific for reporting the frequency and severity of upper gastrointestinal symptoms); * Willingness to follow all study procedures, including attending all site visits, tests and examinations.
Exclusion criteria
* Esophagitis according to the Los Angeles classification (grade A to D); * Diagnosis of Helicobacter pylori infection; * Use of proton pump inhibitors or H2 receptor antagonists in the previous 4 weeks; * Uncontrolled cardiac, renal, liver or pulmonary disease; * Diabetes; * Active malignant neoplasia; * Pregnancy or breast-feeding; * Known allergy to device components; * Simultaneous participation in an interventional study or participation in an interventional study in the last 1 month before study inclusion; * Known drug and/or alcohol abuse; * Mental incapacity that precludes adequate understanding or cooperation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the safety and the tolerability of FIBROIN SYRUP. Safety and the tolerability will be monitored through vital signs. | V-1 (within 7 days before V0); V0 (day 0) V1 (6 week from V0) V2 (12 weeks form V0) | Safety will be monitored through Blood pressure measurement. Blood pressure readings are typically expressed in millimeters of mercury (mmHg) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the performance of the "FIBROIN SYRUP" in reducing the gastroesophageal symptomatology in NERD patients. | V0 (day 0) V1 (6 week from V0) V2 (12 weeks form V0) | The performance of the "FIBROIN SYRUP" in reducing the gastroesophageal symptomatology in NERD patients, will be evaluated by Reflux disease questionnaire (RDQ). The difference in the RDQ score will be evaluated between baseline and EOS visit will be was used to determine how many patients will be included for the STAGE 2. The RDQ score is a patient-reported measure used to assess the frequency and severity of GERD symptoms, such as heartburn and acid regurgitation. Each item is scored on a graded scale, and the responses are summed to produce a total score. The minimum RDQ score is 0, indicating no reflux-related symptoms, while the maximum score typically ranges up to 40 or 60, representing the most frequent and severe symptoms possible. Higher RDQ scores reflect greater symptom burden and disease severity, whereas lower scores indicate mild or absent symptoms. |
| To evaluate the patient's satisfaction | V2 (12 weeks form V0) | To evaluate patient's satisfaction with FIBROIN SYRUP, a 5-Likert Scale will be used. Here's a breakdown of a typical 5 point Likert scale: Strongly Disagree (point 1) - Disagree (point 2) -Neutral (or Neither Agree nor Disagree) (point 3)- Agree (point 4) - Strongly Agree (point 5). This scale allows respondents to express the intensity of their feelings towards a given statement, making it easier to quantify subjective data. It's widely used because it's simple to understand and analyze. |
| The Safety and the tolerability will be monitored through the reporting of the adverse events, serious adverse events and concomitant medications during the entire study duration. | V-1 (within 7 days before V0); V0 (day 0) V1 (6 week from V0) V2 (12 weeks form V0) | The event, date of onset, severity, duration, and relationship to the device will be recorded. Subjects will receive a diary to record any deviation from the normal health status as well as any concomitant medication taken. |
| To evaluate the safety and the tolerability of FIBROIN SYRUP. Safety and the tolerability will be monitored through vital signs. | V-1 (within 7 days before V0); V0 (day 0) V1 (6 week from V0) V2 (12 weeks form V0) | Safety and the tolerability will be monitored through Heart Rate measurement. Heart rate is the frequency of the heartbeat measured by the number of contractions of the heart per minute (beats per minute, or bpm) |
Countries
Italy
Outcome results
None listed