New Topical tReatment Options for Symptomatic patiEnts With Nonerosive gastroesophageaL Reflux dIsease (The RELIEF Trial)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCellmedis
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Crossover
Treatments tested in this trial
Esophageal barrier medical device
DeviceEsophageal 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.
Placebo oral formulation
DeviceOral 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.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Placebo Followed by Esophageal Barrier Medical Device ArmExperimental treatment 2 interventions
Group B: Esophageal Barrier Medical Device Followed by Placebo ArmExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
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 esophageal barrier medical device compared with placebo.
Time frame
Baseline and after 14 days of treatment in each treatment period of the crossover study.2
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 esophageal barrier medical device compared with placebo.
Time frame
After 14 days of treatment in each treatment period of the crossover study.Secondary outcomes
1
Onset and duration of action of the investigational device.
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.
Time frame
During the 14 day treatment period, assessed after each administration throughout each treatment phase.2
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 esophageal barrier medical device compared with placebo.
Time frame
After 14 days of treatment in each treatment period of the crossover study.3
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 esophageal barrier medical device compared with placebo.
Time frame
After 14 days of treatment in each treatment period of the crossover study.4
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 esophageal barrier medical device compared with placebo.
Time frame
After 14 days of treatment in each treatment period of the crossover study.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Cellmedis
Lead sponsor
Medical Network Sp. z o.o.
Collaborator
Source ClinicalTrials.gov