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New Topical tReatment Options for Symptomatic patiEnts With Nonerosive gastroesophageaL Reflux dIsease (The RELIEF Trial) (RELIEF)

2026年7月9日 更新者：Cellmedis

New Topical tReatment Options for Symptomatic patiEnts With Nonerosive gastroesophageaL Reflux dIsease: rEsults oF a Single-center, Randomized, Double-blind, Placebo-controlled Crossover Trial. (The RELIEF Trial)

The goal of this randomized, double-blind, single-center clinical trial RELEIF is to learn if medical devices work to decrease symptoms of gastroesophageal reflux disease (GERD) in adults' patients. It will also teach us about safety, tolerability and improvement of patient's quality of life during and after taking medical device. The main questions it aims to answer are:

  • Does medical device relieve reflux symptoms?
  • Does medical device improve the quality of life of patients with GERD symptoms? Researchers will compare medical device to a placebo (a look-alike substance that contains no drug) to see if medical device works in GERD gastroesophageal reflux disease .

Participants will:

  • Take medical device or a placebo every day (4 times a day) for 14 days
  • Stop taking medical device or placebo for 7 days (wash out period)
  • Switch the therapy for medical device or placebo for next 14 days
  • Visit the clinic 4 times during 35 days of this study for checkups and tests
  • Keep a diary of their symptoms and the number of times they use a medical device
  • Fill out the form to collect all necessary data.

調査の概要

状態

募集

条件

介入・治療

詳細な説明

This medical device was developed as a modern therapeutic alternative, offering rapid symptom relief and long-term protective effects on the esophageal mucosa. The introduction of medical device aims to expand the available therapeutic options for patients suffering from GERD symptoms and to support physicians in selecting optimal therapy. Thanks to its innovative formula, medical device can avoid the rising the symptoms, provide improved well-being and reduce the frequency of acute medication use.

研究の種類

介入

入学 (推定)

50

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。

研究連絡先

研究場所

  • ポーランド
    • Masovian Voivodeship
      • Warsaw、Masovian Voivodeship、ポーランド、04-501
        • 募集
        • Medical Network
        • コンタクト：
        • コンタクト：
        • 副調査官：
          • Konrad Lewandowski, MD, PhD
        • 主任研究者：
          • Grażyna Rydzewska - Wyszkowska, Prof., MD, PhD

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:

  • Diagnosis of gastroesophageal reflux disease based on the presence of typical symptoms such as heartburn and or regurgitation for at least 6 months prior to the screening visit, confirmed by the investigator
  • Exclusion of erosive reflux disease, Barrett esophagus, and other esophageal abnormalities by upper gastrointestinal endoscopy within the last 6 months, confirmed by the investigator based on medical documentation
  • No use within 1 month prior to screening of proton pump inhibitors, H2 receptor antagonists, prokinetics such as itopride or prucalopride, GLP1 or GIP analogues, antibiotics, baclofen, tricyclic antidepressants, serotonin and or noradrenaline reuptake inhibitors, and no use within 1 week prior to screening of sucralfate, antacids, or esophageal mucosal protective agents
  • Presence of gastroesophageal reflux symptoms that negatively impact quality of life, as subjectively reported by the patient and confirmed by the investigator
  • Age 18 years or older at the time of screening
  • Women of childbearing potential must not be pregnant confirmed by a negative urine pregnancy test and must not be breastfeeding, or must be of non childbearing potential defined as surgically sterile, physiologically incapable of becoming pregnant, or at least 12 months post menopause
  • Women of childbearing potential with a male partner of reproductive potential must use a highly effective method of contraception from screening until 18 weeks after the last dose of the investigational medical device
  • Sexually active men with women of childbearing potential must agree to use barrier contraception such as condoms or abstain from sexual intercourse throughout the study period and for at least 7 days after the last dose of the investigational medical device
  • Ability to comply with all aspects of the clinical study
  • Male patients eligible for participation in the study.

Exclusion Criteria:

  • Women who are breastfeeding or have a positive urine pregnancy test at the baseline visit
  • Introduction of significant changes in diet or lifestyle during the study period
  • Presence of alarm symptoms at baseline including dysphagia or odynophagia, unintentional weight loss greater than 5 percent of baseline body weight, signs of gastrointestinal bleeding, anemia, palpable epigastric mass, or persistent vomiting lasting 7 to 10 days
  • Planned use during the study of antibiotics, probiotics, prebiotics, synbiotics, short chain fatty acids, proton pump inhibitors, H2 receptor antagonists, prokinetics such as itopride or prucalopride, GLP1 or GIP analogues, baclofen, tricyclic antidepressants, serotonin and or noradrenaline reuptake inhibitors, and use within 1 week prior to study start of sucralfate, antacids, or esophageal mucosal protective agents
  • Diagnosis of a severe disease such as malignancy
  • Planned hospitalization for any reason or presence of any severe comorbidity that in the opinion of the investigator constitutes a contraindication to study participation or may compromise patient safety
  • Current or recent history within 1 year prior to randomization of alcohol dependence or substance abuse
  • Active psychiatric disorders that in the opinion of the investigator may interfere with compliance with study procedures
  • Presence of unstable or uncontrolled cardiovascular disorders, moderate or severe heart failure classified as New York Heart Association class III or IV, or any clinically significant pulmonary, hepatic, renal, gastrointestinal, genitourinary, hematological, coagulation, immunological, endocrine or metabolic disorder, or any other medical condition that in the opinion of the investigator could affect study results or patient safety
  • Individuals who are employees of the study site, investigator, contract research organization, or sponsor
  • First degree relatives of employees of the study site, investigator, contract research organization, or sponsor
  • Individuals unable to attend all study visits or comply with study procedures.

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：ランダム化
  • 介入モデル：クロスオーバー割り当て
  • マスキング：4倍

武器と介入

参加者グループ / アーム
介入・治療
実験的：Placebo Followed by Esophageal Barrier Medical Device Arm
Participants receive Placebo oral formulation during the first treatment period followed by esophageal barrier medical device during the second treatment period with a washout interval.
デバイス：Esophageal barrier medical device
Esophageal barrier medical device designed to form a bioadhesive protective barrier over gastric contents and the esophageal mucosa. The mechanism of action is local and physical, reducing exposure of the esophagus to refluxate without systemic absorption. The product is administered orally according to the study protocol and evaluated in a randomized, double blind, placebo controlled crossover design, distinguishing it from pharmacological acid suppressive therapies.
デバイス：Placebo oral formulation
Oral placebo formulation designed to match the investigational product in appearance, taste, and administration schedule, without containing active components. It does not form a protective barrier and has no therapeutic effect. The placebo is administered according to the same protocol as the active intervention within a randomized, double blind, placebo controlled crossover design to ensure blinding and allow comparative assessment.
他の名前：
  • プラセボ
  • 一致するプラセボ
  • Inactive comparator formulation
実験的：Esophageal Barrier Medical Device Followed by Placebo Arm
Participants receive esophageal barrier medical device during the first treatment period followed by Placebo oral formulation during the second treatment period with a washout interval.
デバイス：Esophageal barrier medical device
Esophageal barrier medical device designed to form a bioadhesive protective barrier over gastric contents and the esophageal mucosa. The mechanism of action is local and physical, reducing exposure of the esophagus to refluxate without systemic absorption. The product is administered orally according to the study protocol and evaluated in a randomized, double blind, placebo controlled crossover design, distinguishing it from pharmacological acid suppressive therapies.
デバイス：Placebo oral formulation
Oral placebo formulation designed to match the investigational product in appearance, taste, and administration schedule, without containing active components. It does not form a protective barrier and has no therapeutic effect. The placebo is administered according to the same protocol as the active intervention within a randomized, double blind, placebo controlled crossover design to ensure blinding and allow comparative assessment.
他の名前：
  • プラセボ
  • 一致するプラセボ
  • Inactive comparator formulation

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
Change in reflux symptom severity score
時間枠：Baseline and after 14 days of treatment in each treatment period of the crossover study.
Change from baseline in patient reported gastroesophageal reflux symptoms assessed using the GERD-HRQL questionnaire. Clinical response is defined as a reduction of at least 50 percent in the total GERD-HRQL score after 14 days of treatment with esophageal barrier medical device compared with placebo.
Baseline and after 14 days of treatment in each treatment period of the crossover study.
Proportion of patients with complete clinical remission
時間枠：After 14 days of treatment in each treatment period of the crossover study.
Proportion of patients achieving complete clinical remission of gastroesophageal reflux symptoms assessed using the GERD-HRQL questionnaire. Complete remission is defined as a total score of 0 points in questions 1 to 15 of the GERD-HRQL after 14 days of treatment with esophageal barrier medical device compared with placebo.
After 14 days of treatment in each treatment period of the crossover study.

二次結果の測定

結果測定
メジャーの説明
時間枠
Onset and duration of action of the investigational device.
時間枠：During the 14 day treatment period, assessed after each administration throughout each treatment phase.
Assessment of the onset and duration of action of the esophageal barrier medical device using a patient reported questionnaire. Onset of action is defined as the subjective relief of heartburn within two predefined time intervals: up to 15 minutes classified as very rapid onset and 16 to 30 minutes classified as rapid onset. Duration of action is defined as the time period free from reflux symptoms following administration of the investigational product.
During the 14 day treatment period, assessed after each administration throughout each treatment phase.
Proportion of patients with complete clinical remission of heartburn.
時間枠：After 14 days of treatment in each treatment period of the crossover study.
Proportion of patients achieving complete clinical remission of heartburn assessed using the GERD-HRQL questionnaire. Complete remission of heartburn is defined as a total score of 0 points in questions 1 to 6 of the GERD-HRQL after 14 days of treatment with esophageal barrier medical device compared with placebo.
After 14 days of treatment in each treatment period of the crossover study.
Proportion of patients with clinical response of heartburn.
時間枠：After 14 days of treatment in each treatment period of the crossover study.
Proportion of patients achieving clinical response of heartburn assessed using the GERD-HRQL questionnaire. Clinical response is defined as a reduction of at least 50 percent in the total score of questions 1 to 6 of the GERD-HRQL after 14 days of treatment with esophageal barrier medical device compared with placebo.
After 14 days of treatment in each treatment period of the crossover study.
Proportion of patients with complete clinical remission of regurgitation.
時間枠：After 14 days of treatment in each treatment period of the crossover study.
Proportion of patients achieving complete clinical remission of regurgitation assessed using the GERD-HRQL questionnaire. Complete remission of regurgitation is defined as a total score of 0 points in questions 10 to 15 of the GERD-HRQL after 14 days of treatment with esophageal barrier medical device compared with placebo.
After 14 days of treatment in each treatment period of the crossover study.
Proportion of patients with clinical response of regurgitation.
時間枠：After 14 days of treatment in each treatment period of the crossover study.
Proportion of patients achieving clinical response of regurgitation assessed using the GERD-HRQL questionnaire. Clinical response is defined as a reduction of at least 50 percent in the total score of questions 10 to 15 of the GERD-HRQL after 14 days of treatment with esophageal barrier medical device compared with placebo.
After 14 days of treatment in each treatment period of the crossover study.
Change in heartburn and regurgitation severity on Likert scale
時間枠：Baseline and after 14 days of treatment in each treatment period of the crossover study.
Change in severity of heartburn and regurgitation assessed using a five point Likert scale. Improvement is defined as a reduction of at least 2 points in the combined symptom severity score after 14 days of treatment with esophageal barrier medical device compared with placebo.
Baseline and after 14 days of treatment in each treatment period of the crossover study.
Proportion of patients with improvement in quality of life
時間枠：Baseline and after 14 days of treatment in each treatment period of the crossover study.
Proportion of patients achieving improvement in quality of life assessed using the 36 Item Short Form Survey SF 36. Improvement is defined as a reduction of at least 5 points in the total SF 36 score after 14 days of treatment with esophageal barrier medical device compared with placebo.
Baseline and after 14 days of treatment in each treatment period of the crossover study.

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

Cellmedis

協力者

Medical Network Sp. z o.o.

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)

2026年5月28日

一次修了 (推定)

2026年9月30日

研究の完了 (推定)

2026年9月30日

試験登録日

最初に提出

2026年5月28日

QC基準を満たした最初の提出物

2026年5月28日

最初の投稿 (実際)

2026年6月3日

学習記録の更新

投稿された最後の更新 (実際)

2026年7月10日

QC基準を満たした最後の更新が送信されました

2026年7月9日

最終確認日

2026年7月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • AZ001-01-01 (RELIEF Trial)
  • CIV-PL-26-03-057013 (その他の識別子：EUDAMED)

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

IPD プランの説明

Individual participant data will not be made publicly available due to privacy considerations and applicable data protection regulations. Aggregated and anonymized results will be reported in scientific publications. Data may be available from the corresponding author upon reasonable request, subject to institutional approval and data sharing agreements.

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米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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