Reflux Band for Acid Reflux
Recruiting in Palo Alto (17 mi)
Overseen byRena Yadlapati, MD, MSHS
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Waitlist Available
Sponsor: University of California, San Diego
No Placebo Group
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?This trial tests if a special neck band can help people with throat issues caused by stomach acid. The band is worn at night and works by increasing pressure on a muscle to stop acid from reaching the throat.
Do I have to stop taking my current medications for the trial?
The trial does not specify if you need to stop taking your current medications. However, it requires participants to be on a double daily dose acid suppression therapy, so you may need to continue those medications.
What data supports the idea that Reflux Band for Acid Reflux is an effective treatment?
The available research does not provide specific data on the effectiveness of the Reflux Band for Acid Reflux. Instead, it focuses on various drugs like rabeprazole and pantoprazole, which are shown to be effective in relieving symptoms and healing damage caused by acid reflux. These drugs are compared to other treatments, such as H2-receptor antagonists, which are less effective in severe cases. However, there is no direct comparison or data on the Reflux Band in the provided information.
12345What safety data exists for the Reflux Band treatment for acid reflux?
The provided research does not contain specific safety data for the Reflux Band or Reza Band treatment for acid reflux. The studies focus on severe cutaneous adverse reactions to drugs and do not mention the Reflux Band or similar devices. Therefore, no relevant safety data for this treatment is available in the provided research.
678910Is the Reflux Band a promising treatment for acid reflux?
The provided research articles do not mention the Reflux Band or Reza Band as a treatment for acid reflux. They focus on various drugs and therapies for gastroesophageal reflux disease (GERD), such as vonoprazan, lesogaberan, and AZD0865, which are different from the Reflux Band. Therefore, based on the given information, we cannot determine if the Reflux Band is a promising treatment for acid reflux.
511121314Eligibility Criteria
This trial is for adults aged 18-99 with laryngopharyngeal reflux confirmed by tests, who have been on double dose acid suppression therapy. They must not have had neck cancer/surgery, use certain night-time breathing aids, or have specific conditions like glaucoma or a history of foregut surgery. Pregnant/breastfeeding individuals and those unable to consent in English/Spanish are excluded.Inclusion Criteria
I am between 18 and 99 years old and speak English or Spanish.
This criterion means that you need to meet at least one of the listed requirements.
I have had symptoms like voice changes or sore throat for over 8 weeks.
+5 more
Exclusion Criteria
I have carotid artery disease, uncontrolled thyroid disease, a history of stroke, or Marfan's/Ehlers-Danlos Syndrome.
My mental status may be altered due to sedatives or narcotics.
I have had cancer or surgery in my neck area.
+14 more
Participant Groups
The study compares an external device that compresses the upper esophageal sphincter (Reflux Band) against a sham device over 12 weeks to see if it reduces symptoms of acid reflux more effectively. Participants will be randomly assigned to either the real treatment or placebo without knowing which one they receive.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: ExperimentalExperimental Treatment1 Intervention
Participants allocated to the experimental arm will be fit with the UES Compression Device according to manufacturer guidelines.
Group II: ControlPlacebo Group1 Intervention
Participants allocated to the control arm will be fit with the UES Compression Device at a pressure known not to provide intervention.
Reflux Band is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as Reflux Band for:
- Laryngopharyngeal reflux (LPR) disease
🇪🇺 Approved in European Union as Reflux Band for:
- Laryngopharyngeal reflux (LPR) disease
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of California, San DiegoLa Jolla, CA
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Who Is Running the Clinical Trial?
University of California, San DiegoLead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Collaborator
References
Rabeprazole for the prevention of recurrent erosive or ulcerative gastro-oesophageal reflux disease. Rabeprazole Study Group. [2019]To evaluate the efficacy and tolerability of rabeprazole 10 mg and 20 mg versus placebo for the prevention of endoscopically demonstrable relapse in patients previously diagnosed with erosive or ulcerative gastro-oesophageal reflux disease (GORD) who had no oesophageal erosions or ulcerations at study entry. The study also assessed the effectiveness of rabeprazole in preventing GORD symptom recurrence and reductions in quality of life.
Effects of rabeprazole on early symptom relief in gastro-oesophageal reflux disease: the Hellenic Rabeprazole Study Group surveillance study. [2013]In controlled clinical trials, rabeprazole effectively improves symptoms and heals oesophageal erosions in patients with gastro-oesophageal reflux disease (GORD).
Pantoprazole 20 mg is effective for relief of symptoms and healing of lesions in mild reflux oesophagitis. [2019]To investigate the efficacy of a low dose of pantoprazole, a gastric proton pump inhibitor, for the relief of symptoms and healing of lesions in mild gastro-oesophageal reflux disease (GERD), and to compare it with the efficacy of ranitidine.
Pharmacological management of gastro-oesophageal reflux disease. [2018]Gastro-oesophageal reflux disease (GORD) ranges from episodic symptomatic reflux without oesophagitis to severe oesophageal mucosal damage, such as Barrett's metaplasia or peptic stricture. The multifactorial pathogenesis of GORD prevents medical cure of the disease. GORD is a chronic disease with a high tendency to relapse, requiring a long term treatment strategy in practically all patients. Complete healing of all mucosal lesions is not necessarily the aim of treatment in all patients. In milder forms of reflux disease, symptom relief is the most important goal. Many patients with mild GORD do well on symptomatic self-care with antacids and/or alginate. In addition, lifestyle changes should be advised to all patients: these improve symptoms and enhance the efficacy of therapy. In the acute treatment of GORD the prokinetic drug cisapride has been shown to be effective in relieving symptoms and healing grade I to II oesophagitis. Cisapride decreases symptomatic and endoscopic relapse in patients with mild GORD. Histamine H2-receptor antagonists are effective in relieving reflux symptoms in about 50% of patients, but with regard to healing, H2-antagonists appear to be mainly effective in grades I and II and not in higher grades of oesophagitis. Maintenance treatment with H2-antagonists is mainly symptomatically effective in patients with mild GORD. Proton pump inhibitors (PPIs) provide significantly higher healing rates of reflux oesophagitis than H2-antagonists, even in the more severe cases of oesophagitis and Barrett's ulcers. PPIs are also effective in patients with oesophagitis refractory to treatment with H2-antagonists. PPIs have become the drugs of first choice in healing of all patients with more severe forms of reflux oesophagitis, and increasingly also for patients with milder forms of oesophagitis, certainly those who fail to respond to other drugs. In maintenance treatment of GORD, PPIs are the most effective drugs, offering the possibility of keeping nearly all patients in remission with adjusted doses. Current patient data of up to 5 years indicate the safety of this strategy for this period, but the exact consequences of strong acid inhibition over a longer period still have to be clarified. At present, all but a few patients with GORD can be managed adequately by medical therapy.
A novel reflux inhibitor lesogaberan (AZD3355) as add-on treatment in patients with GORD with persistent reflux symptoms despite proton pump inhibitor therapy: a randomised placebo-controlled trial. [2014]o evaluate the efficacy and tolerability of add-on treatment with lesogaberan (AZD3355), a novel reflux inhibitor, in patients with persistent gastro-oesophageal reflux disease (GORD) symptoms despite proton pump inhibitor (PPI) therapy.
Severe cutaneous adverse reactions to drugs: A real-world pharmacovigilance study using the FDA Adverse Event Reporting System database. [2023]Background: Sound drug safety information is important to optimize patient management, but the widely recognized comprehensive landscape of culprit-drugs that cause severe cutaneous adverse reactions (SCARs) is currently lacking. Objective: The main aim of the study is to provide a comprehensive landscape of culprit-drugs for SCARs to guide clinical practice. Methods: We analyzed reports associated with SCARs in the FDA Adverse Event Reporting System database between 1 January 2004 and 31 December 2021 and compiled a list of drugs with potentially serious skin toxicity. According to this list, we summarized the reporting proportions of different drugs and drug classes and conducted disproportionality analysis for all the drugs. In addition, the risk characteristic of SCARs due to different drugs and drug classes was summarized by the positive-negative distribution based on the results of the disproportionality analysis. Results: A total of 77,789 reports in the FDA Adverse Event Reporting System database were considered SCAR-related, of which lamotrigine (6.2%) was the most reported single drug followed by acetaminophen (5.8%) and allopurinol (5.8%) and antibacterials (20.6%) was the most reported drug class followed by antiepileptics (16.7%) and antineoplastics (11.3%). A total of 1,219 drugs were reported as culprit-drugs causing SCARs in those reports, and the largest number of drugs belonged to antineoplastics. In disproportionality analysis, 776 drugs showed at least one positive pharmacovigilance signal. Drugs with the most positive signals were lamotrigine, acetaminophen, furosemide, and sulfamethoxazole/trimethoprim. Conclusion: Our study provided a real-world overview of SCARs to drugs, and the investigation of SCAR positive-negative distribution across different drugs revealed its risk characteristics, which may help optimize patient management.
Individual case safety reports in children in commonly used drug groups - signal detection. [2021]Due to few paediatric drug safety studies, knowledge on risks of drug treatment in children is limited. The knowledge needs to be increased to make proper risk-benefit analyses possible when treating paediatric patients with drugs. The aim of the present study was to investigate drug groups commonly used in children concerning type and frequency of individual case safety reports in children.
The Combined Utility of Ex Vivo IFN-γ Release Enzyme-Linked ImmunoSpot Assay and In Vivo Skin Testing in Patients with Antibiotic-Associated Severe Cutaneous Adverse Reactions. [2019]For severe cutaneous adverse reactions (SCARs) associated with multiple antibiotics dosed concurrently, clinical causality is challenging and diagnostic approaches are limited, leading to constricted future antibiotic choices.
The Weber effect and the United States Food and Drug Administration's Adverse Event Reporting System (FAERS): analysis of sixty-two drugs approved from 2006 to 2010. [2021]The United States Food and Drug Administration's (FDA) Adverse Event Reporting System (FAERS) consists of adverse event (AE) reports linked to approved drugs. The database is widely used to support post-marketing safety surveillance programs. Sometimes cited as a limitation to the usefulness of FAERS, however, is the 'Weber effect,' which is often summarized by stating that AE reporting peaks at the end of the second year after a regulatory authority approves a drug. Weber described this effect in 1984 based upon a single class of medications prescribed in the United Kingdom. Since that time, the FDA has made a concerted effort to improve both reporting and the database itself. Both volume and quality of AE reporting has dramatically improved since Weber's report, with an estimated 800,000 yearly reports now being logged into FAERS.
Delayed Cutaneous Hypersensitivity Reactions to Antibiotics: Management with Desensitization. [2018]Successful desensitization to mild to moderate delayed cutaneous adverse reaction to antibiotics has been described in a limited number of antibiotics and found to be safe. However, there are ample opportunities to standardize protocols for delayed cutaneous adverse reactions to antibiotics.
A study for every second day administration of vonoprazan for maintenance treatment of erosive GERD (ESD von GERD): a multicenter randomized cross-over study. [2022]Vonoprazan is a potassium competitive acid blocker used to treat erosive gastroesophageal reflux disease (GERD) with stronger, more stable acid-suppressing effects than proton pump inhibitors (PPIs). This study clarified the usefulness and superiority of vonoprazan administered every second day over PPIs in the maintenance therapy of erosive GERD.
Pharmacokinetic profile of lesogaberan (AZD3355) in healthy subjects: a novel GABA(B)-receptor agonist reflux inhibitor. [2021]Lesogaberan (AZD3355) is a novel reflux inhibitor developed as an add-on treatment to proton pump inhibitors (PPIs) for symptom relief in patients with gastroesophageal reflux disease who have a partial response to PPI therapy.
A randomized, comparative study of three doses of AZD0865 and esomeprazole for healing of reflux esophagitis. [2022]AZD0865 belongs to a new class of acid-suppressing agents with rapid onset of action and potent acid inhibition. We evaluated its effectiveness for healing reflux esophagitis.
Combination drug therapy for gastroesophageal reflux disease. [2017]To evaluate the role of combination therapy with proton-pump inhibitors (PPIs) and histamine(2) receptor antagonists in gastroesophageal reflux disease (GERD).