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)

NCT07624383 | Not Yet Recruiting DMC

• 1 other identifier: AZ001-01-01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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 the 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

Keywords

gastroesophageal reflux disease; reflux; heartburn; medical device in reflux; regurgitation; quality of life in reflux disease; reflux symptoms; non erosive reflux disease

Outcome Measures

Primary Outcomes (2)

• Change in reflux symptom severity score

  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 alginate based 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

  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 alginate based esophageal barrier medical device compared with placebo.

  After 14 days of treatment in each treatment period of the crossover study.

Secondary Outcomes (7)

• Onset and duration of action of the investigational device.

  During the 14 day treatment period, assessed after each administration throughout each treatment phase.

• Proportion of patients with complete clinical remission of heartburn.

  After 14 days of treatment in each treatment period of the crossover study.

• Proportion of patients with clinical response of heartburn.

  After 14 days of treatment in each treatment period of the crossover study.

• Proportion of patients with complete clinical remission of regurgitation.

  After 14 days of treatment in each treatment period of the crossover study.

• Proportion of patients with clinical response of regurgitation.

  After 14 days of treatment in each treatment period of the crossover study.

Study Arms (2)

Placebo Followed by Esophageal Barrier Medical Device Arm

EXPERIMENTAL

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.

Device: Esophageal barrier medical device; Device: Placebo oral formulation

Esophageal Barrier Medical Device Followed by Placebo Arm

EXPERIMENTAL

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.

Device: Esophageal barrier medical device; Device: Placebo oral formulation

Interventions

Esophageal barrier medical device 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.

Esophageal Barrier Medical Device Followed by Placebo Arm; Placebo Followed by Esophageal Barrier Medical Device Arm

Placebo oral formulation DEVICE

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.

Also known as: Placebo, Matching placebo, Inactive comparator formulation

Esophageal Barrier Medical Device Followed by Placebo Arm; Placebo Followed by Esophageal Barrier Medical Device Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cellmedis: lead
• Medical Network Sp. z o.o.: collaborator

Study Sites (1)

Medical Network

Warsaw, Masovian Voivodeship, 04-501, Poland

Location

MeSH Terms

Conditions

Gastroesophageal Reflux; Heartburn; Non-Erosive Reflux Disease

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Anna Zaorska, MD

CONTACT

+48 602 229 443; anna.zaorska@cellmedis.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Sponsor
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Interventional, randomized, double-blind, cross over study

Study Record Dates

• First Submitted: May 28, 2026
• First Posted: June 3, 2026
• Study Start: May 28, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: June 3, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)