RecruitingNot ApplicableNCT07624383

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

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)


Sponsor

Cellmedis

Enrollment

50 participants

Start Date

May 28, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Esophageal barrier medical device and a medical device called Placebo oral formulation for people with gerd (gastroesophageal reflux disease), heartburn, and other related conditions. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEEsophageal 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.

DEVICEPlacebo 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.


Locations(1)

Medical Network

Warsaw, Masovian Voivodeship, Poland

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NCT07624383


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