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
2026年4月30日 更新者：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.
調査の概要
状態
完了
詳細な説明
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
研究の種類
介入
入学 (実際)
47
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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BO
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Bologna、BO、イタリア、40121
- UOC Medicina Interna Cardiovascolare - Centro Endoscopia Digestiva - Policlinico di Sant'Orsola - Bologna
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
To evaluate the safety and the tolerability of FIBROIN SYRUP. Safety and the tolerability will be monitored through vital signs.
時間枠：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)
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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To evaluate the performance of the "FIBROIN SYRUP" in reducing the gastroesophageal symptomatology in NERD patients.
時間枠：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
時間枠：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.
時間枠：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.
時間枠：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.
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2024年7月24日
一次修了 (実際)
2025年7月31日
研究の完了 (実際)
2025年8月8日
試験登録日
最初に提出
2025年11月27日
QC基準を満たした最初の提出物
2026年4月30日
最初の投稿 (実際)
2026年5月4日
学習記録の更新
投稿された最後の更新 (実際)
2026年5月4日
QC基準を満たした最後の更新が送信されました
2026年4月30日
最終確認日
2026年4月1日
詳しくは
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