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

9 luglio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

50

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Polonia
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Polonia, 04-501
        • Reclutamento
        • Medical Network
        • Contatto:
        • Contatto:
        • Sub-investigatore:
          • Konrad Lewandowski, MD, PhD
        • Investigatore principale:
          • Grażyna Rydzewska - Wyszkowska, Prof., MD, PhD

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione incrociata
  • Mascheramento: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Dispositivo: 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.
Dispositivo: 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.
Altri nomi:
  • Placebo
  • Placebo corrispondente
  • Inactive comparator formulation
Sperimentale: 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.
Dispositivo: 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.
Dispositivo: 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.
Altri nomi:
  • Placebo
  • Placebo corrispondente
  • Inactive comparator formulation

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in reflux symptom severity score
Lasso di tempo: 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
Lasso di tempo: 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.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Onset and duration of action of the investigational device.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Cellmedis

Collaboratori

Medical Network Sp. z o.o.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

28 maggio 2026

Completamento primario (Stimato)

30 settembre 2026

Completamento dello studio (Stimato)

30 settembre 2026

Date di iscrizione allo studio

Primo inviato

28 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

28 maggio 2026

Primo Inserito (Effettivo)

3 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

10 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

9 luglio 2026

Ultimo verificato

1 luglio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • AZ001-01-01 (RELIEF Trial)
  • CIV-PL-26-03-057013 (Altro identificatore: EUDAMED)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

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.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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