A Pre-market, Two-stages Interventional Clinical Investigation to Evaluate the Safety and the Performance of Fibroin Syrup in Reducing the Gastroesophageal Reflux Disease (GERD) Symptomatology in Nonerosive Reflux Disease (NERD) Patients
30. april 2026 oppdatert av: Rose Pharma SA
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.
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Detaljert beskrivelse
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
Studietype
Intervensjonell
Registrering (Faktiske)
47
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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BO
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Bologna, BO, Italia, 40121
- UOC Medicina Interna Cardiovascolare - Centro Endoscopia Digestiva - Policlinico di Sant'Orsola - Bologna
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Adult patients suffering from gastroesophageal reflux disease
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Syrup made by hyaluronic acid that forms a protective layer that adheres to the esophageal mucosa and has a mechanical action
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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To evaluate the safety and the tolerability of FIBROIN SYRUP. Safety and the tolerability will be monitored through vital signs.
Tidsramme: V-1 (within 7 days before V0); V0 (day 0) V1 (6 week from V0) V2 (12 weeks form V0)
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Safety will be monitored through Blood pressure measurement.
Blood pressure readings are typically expressed in millimeters of mercury (mmHg)
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V-1 (within 7 days before V0); V0 (day 0) V1 (6 week from V0) V2 (12 weeks form V0)
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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To evaluate the performance of the "FIBROIN SYRUP" in reducing the gastroesophageal symptomatology in NERD patients.
Tidsramme: V0 (day 0) V1 (6 week from V0) V2 (12 weeks form V0)
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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.
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V0 (day 0) V1 (6 week from V0) V2 (12 weeks form V0)
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To evaluate the patient's satisfaction
Tidsramme: V2 (12 weeks form V0)
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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.
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V2 (12 weeks form V0)
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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.
Tidsramme: V-1 (within 7 days before V0); V0 (day 0) V1 (6 week from V0) V2 (12 weeks form V0)
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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.
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V-1 (within 7 days before V0); V0 (day 0) V1 (6 week from V0) V2 (12 weeks form V0)
|
|
To evaluate the safety and the tolerability of FIBROIN SYRUP. Safety and the tolerability will be monitored through vital signs.
Tidsramme: 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)
|
V-1 (within 7 days before V0); V0 (day 0) V1 (6 week from V0) V2 (12 weeks form V0)
|
|
To evaluate the safety and the tolerability of FIBROIN SYRUP. Safety and the tolerability will be monitored through vital signs.
Tidsramme: 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 measurement of the oxygen levels. 2 refers to the percentage of oxygen-saturated hemoglobin relative to total hemoglobin in the blood.
The measurement of O2 is performed using a non-invasive device known as a pulse oximeter.
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V-1 (within 7 days before V0); V0 (day 0) V1 (6 week from V0) V2 (12 weeks form V0)
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Samarbeidspartnere og etterforskere
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Sponsor
Studierekorddatoer
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Studer hoveddatoer
Studiestart (Faktiske)
24. juli 2024
Primær fullføring (Faktiske)
31. juli 2025
Studiet fullført (Faktiske)
8. august 2025
Datoer for studieregistrering
Først innsendt
27. november 2025
Først innsendt som oppfylte QC-kriteriene
30. april 2026
Først lagt ut (Faktiske)
4. mai 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
4. mai 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
30. april 2026
Sist bekreftet
1. april 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- RF-FibroinS-2024
Plan for individuelle deltakerdata (IPD)
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NEI
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