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

NCT07624383 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-07-10

No results posted yet for this study

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.

Conditions

  • GERD (Gastroesophageal Reflux Disease)
  • NERD
  • Heartburn
  • Regurgitation, Gastric

Interventions

DEVICE

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.

DEVICE

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.

Sponsors & Collaborators

  • Medical Network Sp. z o.o.

    collaborator UNKNOWN

  • Cellmedis

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-28
Primary Completion
2026-09-30
Completion
2026-09-30

Countries

  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07624383 on ClinicalTrials.gov