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New treatment option for GERD (Gastroesophageal Reflux Disease)
Official title New Topical tReatment Options for Symptomatic patiEnts With Nonerosive gastroesophageaL Reflux dIsease (The RELIEF Trial)
ClinicalTrials.gov ID: NCT07624383
What this study is testing
- What it's testing
- 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.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Diagnosis of gastroesophageal reflux disease based on the presence of typical symptoms such as heartburn and or regurgitation for at least 6 months...
- Exclusion of erosive reflux disease, Barrett esophagus, and other esophageal abnormalities by upper gastrointestinal endoscopy within the last 6...
- No use within 1 month prior to screening of proton pump inhibitors, H2 receptor antagonists, prokinetics such as itopride or prucalopride, GLP1 or...
- Presence of gastroesophageal reflux symptoms that negatively impact quality of life, as subjectively reported by the patient and confirmed by the...
- Age 18 years or older at the time of screening
You likely can't join 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...
- Planned use during the study of antibiotics, probiotics, prebiotics, synbiotics, short chain fatty acids, proton pump inhibitors, H2 receptor...
- 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...
See the full eligibility criteria
Who can join
- 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...
- 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...
- 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...
- Ability to comply with all aspects of the clinical study
- Male patients eligible for participation in the study.
What rules you out
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Warsaw, Masovian Voivodeship, Poland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Warsaw, Masovian Voivodeship, Poland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.