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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
50
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.
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.
Medical Network
Warsaw, Masovian Voivodeship, Poland
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.
Time frame: 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.
Time frame: After 14 days of treatment in each treatment period of the crossover study.
Onset and duration of action of the investigational device.
Assessment of the onset and duration of action of the alginate based 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.
Time frame: During the 14 day treatment period, assessed after each administration throughout each treatment phase.
Proportion of patients with complete clinical remission of heartburn.
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 alginate based esophageal barrier medical device compared with placebo.
Time frame: After 14 days of treatment in each treatment period of the crossover study.
Proportion of patients with clinical response of heartburn.
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 alginate based esophageal barrier medical device compared with placebo.
Time frame: After 14 days of treatment in each treatment period of the crossover study.
Proportion of patients with complete clinical remission of regurgitation.
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 alginate based esophageal barrier medical device compared with placebo.
Time frame: After 14 days of treatment in each treatment period of the crossover study.
Proportion of patients with clinical response of regurgitation.
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 alginate based esophageal barrier medical device compared with placebo.
Time frame: After 14 days of treatment in each treatment period of the crossover study.
Change in heartburn and regurgitation severity on Likert scale
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 alginate based esophageal barrier medical device compared with placebo.
Time frame: Baseline and after 14 days of treatment in each treatment period of the crossover study.
Proportion of patients with improvement in quality of life
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 alginate based esophageal barrier medical device compared with placebo.
Time frame: Baseline and after 14 days of treatment in each treatment period of the crossover study.
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