Treatment Trials

345 Clinical Trials for Various Conditions

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A Study to Evaluate Vonoprazan in Children Who Have Symptomatic Gastroesophageal Reflux Disease
Description

The aim of this study is to evaluate the pharmacokinetic (PK) profile of vonoprazan (10 or 20 mg once daily \[QD\]) in children ≥ 6 to \< 12 years of age who have symptomatic Gastroesophageal Reflux Disease (GERD).

Conditions

Gastroesophageal Reflux Disease

Diagnostic Tests in Supra-Esophageal Gastroesophageal Reflux Disease (SE-GERD)
Description

After defining the manometric characteristics of UES incompetence associated with documented pharyngeal reflux, we will determine the reproducibility of manometric criteria for UES incompetence in prevention of pharyngeal reflux. We hypothesize that these criteria are comprised of either a single or constellation of manometric abnormalities. After determining the ability of externally applied cricoid cartilage pressure in preventing pharyngeal reflux, we further hypothesize that this approach will eliminate or reduce esophago-pharyngeal reflux by enhancing the UES pressure barrier. We anticipate there will be a close spatial correlation between the site of applied pressure and area of increased pressure within UES high pressure zone. Lastly, we will determine and characterize the effect of externally applied cricoid cartilage pressure on related functions such as belch and swallow, testing the hypothesis that these functions will not be impaired.

Conditions

Gastroesophageal Reflux

A Study to Evaluate the Pharmacokinetics, Pharmacodynamics and Safety of Vonoprazan in Adolescents With Symptomatic Gastroesophageal Reflux Disease
Description

The primary objective of this study is to evaluate the pharmacokinetic profile of vonoprazan in adolescent participants with symptomatic gastroesophageal reflux disease (GERD).

Conditions

Gastroesophageal Reflux

Targeting Hypervigilance and Autonomic Arousal: the Psycho-physiologic Model of Gastroesophageal Reflux Disease (GERD)
Description

GERD affects roughly 20% of the U.S. population and the direct and indirect costs of GERD are substantial, totaling close to 50 billion dollars per year. Evidence supports that a large proportion of this cost and poor clinical outcomes in GERD are related to poor healthcare decisions by both the physician and the patient. The problem of inappropriate GERD management stems from three main issues. First, the disease is heterogeneous and requires treatment informed by a precision model. Second, the current paradigm largely ignores the important brain-gut interactions that drive symptoms and healthcare utilization. Third, there is a paucity of well-performed comparative effectiveness trials focused on assessing treatments beyond acid suppression. We will use physiomarkers defined during the previous funding cycle to phenotype the patients and use cognitive behavioral interventions to modulate hypervigilance to test the Psycho-Physiologic Model of GERD. Cognitive Behavioral Therapy (CBT) is able to improve hypervigilance and symptom specific autonomic arousal and thus, we will test our theory that CBT can improve outcomes in GERD by targeting these two important psychologic stressors. We will also continue our focus on the interplay of psychology and physiology by determining whether increased mucosal permeability is associated with reflux perception and whether this is modified by hypervigilance and autonomic disruption.

Conditions

Gastroesophageal Reflux

Tolerability Study of a Novel Microbiome Therapeutic in Subjects With Gastroesophageal Reflux Disease
Description

This is a remote study. No office visits required. The purpose and efficacy endpoint of this study is to assess whether GERD patients tolerate ISOT-101. In addition, usage of the ReQuest validated questionnaire to measure GERD symptoms will be explored as well as usage of the validated SF-36 quality of life (QoL) questionnaire. Each subject serves as his/her own control. Relative tolerability in subjects both on and off proton pump inhibitors (PPIs) will be compared. Subjects naive to PPIs, currently taking PPIs and historically on PPIs will be evaluated with ReQuest and QoL scores. In addition, survey measurements will be taken on a subset of 10 subjects that are non-responders to PPIs. These will not be included in the statistical analysis with the above groups. A tertiary endpoint of this study is to assess any relevant adverse events that occur.

Conditions

Gastroesophageal Reflux

Gracie Diet for Gastroesophageal Reflux Disease
Description

The goal of this clinical trial is to learn if dietary changes can help improve gastroesophageal reflux disease (GERD) symptoms. The main question\[s\] it aims to answer whether the Gracie Diet is an option to treat GERD symptoms in individuals wish to discontinue standard doses of PPI and / or H2 receptor antagonists. Participants will be taken off PPI and be placed on the Gracie Diet for 8 weeks. Information about the participants reflux symptoms and GERD health related quality of life will be collected to assess the effect of the diet.

Conditions

Gastroesophageal Reflux, GERD

Trial of IW-3718 for 8 Weeks in Patients With Persistent Gastroesophageal Reflux Disease (GERD) Receiving Proton Pump Inhibitors (PPIs)
Description

The objective of this study is to evaluate the safety and efficacy of IW-3718 administered to patients with GERD who continue to have persistent symptoms, such as heartburn and regurgitation, while receiving once-daily (QD), standard dose PPIs.

Conditions

Gastroesophageal Reflux Disease (GERD)

A Trial of IW-3718 for 8 Weeks in Patients With Persistent Gastroesophageal Reflux Disease (GERD) Receiving Proton Pump Inhibitors (PPIs)
Description

The objective of this study is to evaluate the safety and efficacy of IW-3718 administered to patients with GERD who continue to have persistent symptoms, such as heartburn and regurgitation, while receiving once-daily (QD), standard-dose PPIs.

Conditions

Gastroesophageal Reflux Disease (GERD)

Confocal Endomicroscopy for Permeability of Esophageal Wall in Refractory Gastroesophageal Reflux Disease (GERD)
Description

Confocal Endomicroscopy for Permeability of Esophageal Wall in Refractory Gastroesophageal Reflux Disease (GERD)

Conditions

Gastro Esophageal Reflux, Barrett Esophagus, Erosive Esophagitis

A Trial of IW-3718 for 8 Weeks in Patients With Symptomatic Gastroesophageal Reflux Disease (GERD)
Description

The objectives of this study are to evaluate the safety, efficacy, and dose-response relationship of IW-3718 administered orally to participants who have GERD and continue to experience GERD symptoms while receiving once-daily (QD), standard-dose proton pump inhibitors (PPIs).

Conditions

Gastroesophageal Reflux Disease

A Study to Check the Safety of Dexlansoprazole and Learn if it Can Treat Symptomatic Nonerosive Gastroesophageal Reflux Disease in Children 2 to 11 Years Old
Description

Gastroesophageal reflux disease (GERD) is caused by food or acid coming up from the stomach into the esophagus, repeatedly. The esophagus is the tube that carries food and liquids from the mouth to the stomach. The body uses stomach acid to break down food, but when acid rises up into the esophagus it can hurt or damage it. People with GERD often feel food coming back up into the throat and mouth and have a burning feeling in their stomach, chest, or throat, called heartburn. Other symptoms of GERD include pain in the stomach or throat, difficulty eating, and throwing up. Symptomatic nonerosive GERD is a condition where people have the symptoms of GERD but the esophagus has not been damaged. People of all ages can have GERD. The causes of GERD in children are similar to those in adults and teenagers. Dexlansoprazole is a medicine that has been shown to help relieve the symptoms of GERD in adults and teenagers. This study aims to find out if dexlansoprazole doses given to children with symptomatic nonerosive GERD, based on their body weight, helps them feel better.

Conditions

Gastroesophageal Reflux Disease (GERD)

Gastroesophageal Reflux Disease Prospective Registry
Description

The purpose of this registry is to evaluate information to determine which operations and treatments for gastroesophageal reflux disease or similar diseases of the stomach, esophagus or digestive tract are providing the most benefit including the long-term effects of treatment (or no treatment) and the progression of the disease over time.

Conditions

GERD

Morphological Markers of Gastroesophageal Reflux Disease (GERD)
Description

The purpose of this project is to learn more about a new and promising way to diagnose acid reflux disease using a very high-powered microscope. This special microscope provides much finer detail than typical microscopes previously used for diagnosing reflux, and may help doctors to better identify children with acid reflux.

Conditions

Eosinophilic Esophagitis, Gastroesophageal Reflux Disease

Proton Pump Inhibitor (PPI) Responsive Eosinophilic Esophagitis EoE: Gastroesophageal Reflux Disease (GERD) or Eosinophilic Esophagitis (EoE)?
Description

The investigators would like to determine if there are patients with PPI responsive Eosinophilic Esophagitis Infiltration that have significant loss of esophageal distensibility suggestive of esophageal fibrosis typical of classic Eosniophilic Esophagitis. If this group of patients exists, the investigators would like to determine if they have the typical endoscopic features of EoE rather than those of GERD.

Conditions

Erosive Esophagitis

Decision Aid for Gastroesophageal Reflux Disease Management
Description

The study is to test a decision aid that is designed to help patients make decision regarding management of their gastroesophageal reflux disease (GERD). Once the decision aid is constructed we will test and assess the aid on \~100 patients who have GERD to assess effectiveness.

Conditions

Gastroesophageal Reflux Disease, Esophageal Cancer, Barrett's Esophagus

Impact of Weight Loss on Gastroesophageal Reflux Disease in Overweight and Obese Subjects: a Prospective Study
Description

By affecting the gastroesophageal pressure gradient, obesity predisposes to reflux of gastric contents. The investigators hypothesized that the loss of weight will decrease this gradient and as a result decrease the severity and frequency of GERD symptoms. GERD negatively affects health related quality of life. Since loss of weight may decrease gastroesophageal reflux, the investigators hypothesized that it obesity contributes to poor quality of life in GERD subjects and losing weight should also favorably impact and improve quality of life in GERD patients.

Conditions

GERD, Obesity

Anthropometry in Gastroesophageal Reflux Disease and Esophageal Injury
Description

Is waist to hip ratio (WHR), waist circumference (WC), (as markers of visceral adiposity) associated with an increase in acidic and non acidic reflux as well as systemic inflammation involving esophageal mucosa, thereby increasing esophageal injury and predisposing to subsequent development of Barrett's esophagus (BE)?

Conditions

Gastroesophageal Reflux Disease (GERD)

Selective 5-HT4 Receptor Agonist and Proton Pump Inhibitor (PPI) in Subjects With Gastroesophageal Reflux Disease (GERD)
Description

The aim of this study is to establish a dose-related effect of a selective 5-HT4 receptor agonist compared to placebo on residual symptoms (regurgitation with or without heartburn) in subjects with GERD who have persistent symptoms while on PPI therapy.

Conditions

Gastroesophageal Reflux Disease

Retrospective TIF Study for Treatment of Gastroesophageal Reflux Disease (GERD). The RetroTIF Study
Description

The purpose of this retrospective, open-label, post-market study is to evaluate the safety and efficacy of Transoral Incisionless Fundoplication (TIF) performed with EsophyX (brand name) in a broad range of GastroEsophageal Reflux Disease (GERD) patients treated at high volume centers across the United States.

Conditions

Gastroesophageal Reflux Disease (GERD)

Can We Predict Who Has Gastroesophageal Reflux Disease (GERD)?
Description

Gastroesophageal reflux disease (GERD) is currently defined as "a condition which develops when the reflux of stomach contents causes troublesome symptoms and/or complications". Doctors often diagnose and treat GERD based on symptoms of heartburn and regurgitation. In recent years, the prevalence of partial or non-response to Proton Pump Inhibitors (PPI) has increased resulting in diagnostic testing with esophagogastroduodenoscopy (EGD) or ambulatory pH monitoring. Most patients do not have endoscopic evidence for reflux. Thus, in this group pH monitoring has emerged as an important physiologic test to determine the degree of esophageal acid exposure and to assess the association between patients' persistent symptoms and acid reflux events. The aims of this study are to assess the sensitivity and specificity of symptom associated indices and determine the best parameter for predicting GERD from a list of conventional pH measurement findings.

Conditions

Gastroesophageal Reflux Disease

Rubber Band Ligation and Mucosectomy for Gastroesophageal Reflux Disease (GERD)
Description

The purpose of this study is to determine the safety and effectiveness of two separate procedures to treat gastroesophageal reflux disease (GERD) also known as heartburn. The two therapies are: 1) a banding procedure alone using the Cook® 6 Shooter™ Saeed Multi-Band Ligator or 2) a banding/shaving procedure called Endoscopic Mucosal Resection (EMR) using the Cook® Duette™ Multi-Band Mucosectomy device.

Conditions

Gastroesophageal Reflux Disease, Heartburn, Regurgitation, Dyspepsia

A Study to Evaluate the Safety, Tolerability and Pharmacodynamics of Pumosetrag in Patients With Gastroesophageal Reflux Disease (GERD)
Description

The purpose of this study is to determine if pumosetrag is effective in treating Gastroesophageal Reflux Disease (GERD) symptoms in patients who have a history of GERD symptoms and are currently taking an acid suppression therapy, such as a Proton Pump Inhibitor (PPI).

Conditions

Gastroesophageal Reflux Disease

Transoral Incisionless Fundoplication (TIF) Registry Study for Treatment of Gastroesophageal Reflux Disease (GERD)
Description

The study objective is to evaluate the safety and efficacy of TIF among a broad range of GERD patients treated in routine clinical practice at multiple centers across the United States.

Conditions

Gastroesophageal Reflux Disease, Hiatal Hernia

Gastroesophageal Reflux Disease (GERD)/Nighttime Heartburn and Driving Performance
Description

The implications of sleep as it relates to the physiology and pathogenesis of a number of diseases has until recently been ignored. With the evolution of sleep laboratories, there is an emerging recognition of the relationship between sleep and various gastrointestinal diseases- in particular gastroesophageal reflux disease (GERD).( 1-5) It seems intuitive that waking/daytime activities or events may affect sleep and that any consequent sleep dysfunction may reciprocally further affect daytime function

Conditions

GERD

A Study to Estimate Effect of 4 Different Doses of AZD3355 on Reflux Episodes, Which Patients With Gastroesophageal Reflux Disease (GERD) May Experience
Description

The purpose of the study is to estimate what effect 4 different doses of AZD3355 will have on the number of reflux episodes, in patients who have GERD and still experience symptoms despite proton pump inhibitor (PPI) treatment.

Conditions

Gastroesophageal Reflux Disease

Study to Evaluate the Effect of a Very Low Carbohydrate Diet on Gastroesophageal Reflux Disease
Description

The purpose of this research study is to learn if a very low carbohydrate (sugar) diet or traditional low fat diet is able to reduce symptoms related to gastroesophageal reflux disease (GERD) in people who are overweight. Patients with GERD may experience all or some of the following symptoms: stomach acid or partially digested food re-entering the esophagus (which is sometimes referred to as heartburn or regurgitation) and belching. In this study, the investigators also hope to find out if acid in the esophagus is reduced more by a low carbohydrate diet than a low fat diet.

Conditions

Gastroesophageal Reflux Disease, Overweight, Acid Reflux Disease

A Study to Evaluate the Efficacy and Safety of Arbaclofen Placarbil (XP19986) as Adjunctive Therapy in Subjects With Gastroesophageal Reflux Disease (GERD)
Description

The purpose of the study is to evaluate efficacy and safety of arbaclofen placarbil (XP19986) versus placebo as adjunctive therapy in subjects with troublesome GERD symptoms despite therapy with approved doses of a Proton Pump Inhibitor (PPI).

Conditions

Gastroesophageal Reflux Disease

Comparing the Efficacy, Safety, and Tolerability of Rabeprazole ER 50 mg With Placebo in Subjects With Symptomatic Gastroesophageal Reflux Disease (sGERD)
Description

The purpose of this study is to compare the efficacy, safety and tolerability of rabeprazole extended release (ER) 50 mg with placebo in subjects with symptomatic gastroesophageal reflux disease (sGERD).

Conditions

Symptomatic Gastroesophageal Reflux Disease (sGERD)

Open Label Safety Study of Enteric-Coated Spheroid Suspension in Infants Aged Less Than 12 Months With Presumed Gastroesophageal Reflux Disease (GERD)
Description

The purpose of this study is to provide additional information on safety and tolerability after multiple does of pantoprazole. Only patients who successfully completed the 3001B3-331 study (NCT00362609) or 3001B3-333 study (NCT00259012) are eligible to participate in this study.

Conditions

Gastroesophageal Reflux

A Pharmacokinetics, Pharmacodynamics and Safety Study of Rabeprazole in New Born Infants With Gastroesophageal Reflux Disease (GERD)
Description

The purpose of this study is to evaluate the pharmacokinetics, pharmacodynamics, and the safety of rabeprazole sodium for the treatment of gastroesophageal reflux disease (GERD) in newborns and pre-term infants.

Conditions

Gastroesophageal Reflux