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Esophagitis, Peptic clinical trials

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NCT ID: NCT02954848 Completed - Clinical trials for Non-erosive Gastroesophageal Reflux Disease

Phase 3 Study of TAK-438 10 mg in the Treatment of Non-Erosive Gastroesophageal Reflux Disease (NERD)

Start date: November 15, 2016
Phase: Phase 3
Study type: Interventional

The purpose of this study was to evaluate the efficacy and safety of oral TAK-438 10 mg once-daily in the treatment of non-erosive gastroesophageal reflux disease (NERD).

NCT ID: NCT02907632 Completed - Clinical trials for Gastroesophageal Reflux

Methoclopramide for Gastroesophageal Reflux in Premature Infants

Start date: April 26, 2017
Phase: Phase 4
Study type: Interventional

Gastroesophageal Reflux (GER) is a condition that affects the majority of premature infants that are followed at the Kangaroo Mother Care Program (ambulatory program for preterm infants discharged with their mothers in continuous skin to skin contact and strict outpatient follow up). For over 20 years, the use of Metoclopramide has been systematic among all preterm infants according to the protocols of the Kangaroo Mother Care (KMC) Program . The aim of this clinical trial is to evaluate the effectiveness and security of metoclopramide to lessen the symptoms of GRE in premature infants that are followed and treated in the Ambulatory KMC Program before 40 weeks of gestational age. Design: Randomized, double blind trial, controlled with placebo. Eligible Population: Premature infants that are followed and treated in the Ambulatory Kangaroo Mother Care Program at Hospital Universitario San Ignacio before 40 weeks of gestational age, which systematically receive: metoclopramide 0.2 mg per kg, every 8 hours, 15 minutes before every feeding up to 40 weeks of gestational age, between January 01 2017 and December 31 2017.Outcomes: Incidence of regurgitation episodes reported by the parents of the infants, episodes of apnea, bronchoaspiration, postprandial irritability, the infant rejects feeding, alteration in the postprandial posture and the frequency and severity of adverse effects associated with the use of Metoclopramide such as extrapyramidal symptoms and sedation. In the case of continuous variables, the mean and median will be compared according to the distribution and for nominal variables, a chi squared test or fisher test will be carried out. Duration: 12 months. Ethical Aspects: Experiment with minimum mayor risk. Informed consent will be requested to parents. An independent committee from the work group will be in charge of carrying out the follow-up of the safety and progression of the study. A methodological expert, a thematic expert, a statistician and an expert in bioethics will constitute the committee. Financial Disclosure: The study will be funded through the Kangaroo Foundation with the collaboration of the " Hospital Universitario San Ignacio", Bogotá, Colombia.

NCT ID: NCT02890979 Completed - Clinical trials for Esophageal Squamous Cell Carcinoma

Swallowable Sponge Cell Sampling Device and Next Generation Sequencing in Detecting Esophageal Cancer in Patients With Low or High Grade Dysplasia, Barrett Esophagus, or Gastroesophageal Reflux Disease

Start date: August 3, 2016
Phase: N/A
Study type: Interventional

This pilot clinical trial studies how well a swallowable sponge cell sampling device and next generation sequencing work in detecting esophageal cancer in patients with low or high grade dysplasia, Barrett esophagus, or gastroesophageal reflux disease. Checking biomarkers in abnormal esophageal cells using a swallowable sponge cell sampling device and next generation sequencing may improve diagnosis and treatment of esophageal cancer.

NCT ID: NCT02873689 Completed - Clinical trials for Gastroesophageal Reflux Disease

Efficacy and Safety of Dexlansoprazole on Heartburn Relief in Chinese Patients

Start date: December 27, 2016
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine the efficacy and safety of dexlansoprazole compared to placebo in relief of daytime and nighttime heartburn over 4 weeks in Chinese participants with symptomatic non-erosive Gastroesophageal Reflux Disease (GERD).

NCT ID: NCT02837627 Completed - Clinical trials for Gastroesophageal Reflux

Effect of Tube Feeding on Gastroesophageal Reflux in Preterm Infants

FT-GER-SO
Start date: January 1, 2016
Phase:
Study type: Observational

Due to several promoting factors, gastro-esophageal reflux (GER) is very frequent in preterm infants. To limit the potentially harmful widespread of pharmacological treatment, a step-wise approach, which firstly undertakes conservative strategies, is currently considered the best choice to manage GER in the preterm population. Among the most common conservative strategies, postural measures seem to effectively reduce GER features in symptomatic preterm babies, whereas feed thickening is almost ineffective. Due to their prematurity, preterm infants <34 weeks gestation are often unable to coordinate sucking, swallowing and breathing, thus requiring a feeding tube to ensure adequate enteral intakes. Continuous feeding and boluses are the most common techniques of enteral tube feeding in Neonatal Intensive Care Units; at present, however, the effects of these techniques on GER features have not been clearly established. This observational, prospective and explorative study primarily aims to evaluate the effect of different techniques of enteral tube feeding on GER frequency and features in symptomatic preterm infants (gestational age ≤33 weeks) undergoing a diagnostic combined pH and multiple intraluminal impedance (pH-MII) for GER evaluation.

NCT ID: NCT02759393 Enrolling by invitation - Clinical trials for Gastroesophageal Reflux Disease

Treatment Effect Between Dexlansoprazole and Double-dose Lansoprazole in Obesity Patients With Reflux Esophagitis

Start date: October 2015
Phase: Phase 4
Study type: Interventional

The purpose of this study is to investigate whether dexlansoprazole can be as effective as double dose PPI to achieve SSR in high BMI cases with reflux esophagitis in Los Angeles grades A & B.

NCT ID: NCT02755753 Completed - Clinical trials for Gastroesophageal Reflux

A Study to Evaluate REbamiPide as an Adjuvant Regimen to Heal erosIve Reflux Esophagitis

REPAIR
Start date: January 2014
Phase: Phase 4
Study type: Interventional

The purpose of this study is to evaluate whether Rebamipide facilitate the healing of inflamed mucosa as an adjuvant regimen in erosive reflux esophagitis (ERE).

NCT ID: NCT02749071 Terminated - Clinical trials for Gastroesophageal Reflux

An Investigation of the EndoStim® Lower Esophageal Sphincter (LES) Stimulation System for the Treatment of Reflux

Start date: May 2016
Phase: N/A
Study type: Interventional

The purpose of this investigation is to demonstrate the safety and effectiveness of Lower Esophageal Sphincter (LES) Stimulation System in treating gastroesophageal reflux disease (GERD). This investigation is a multicenter, randomized, double-blind, sham-controlled study. After the implant procedure, subjects will be randomized to either the Treatment Group (immediate stimulation) or Control Group (delayed stimulation) for six months followed by an additional open-label phase in which all subjects will receive electrical stimulation. Subjects continue on stimulation treatment in an extended open-label follow-up phase through 5 years post-stimulation.

NCT ID: NCT02706938 Completed - Clinical trials for Gastroesophageal Reflux Disease

Impact of Head of Bed Elevation in Symptoms of Patients With Gastroesophageal Reflux Disease

IBELGA
Start date: April 8, 2016
Phase: N/A
Study type: Interventional

BACKGROUND: Gastroesophageal reflux disease is a very frequent clinical condition and nocturnal symptoms are a cause of quality of life impairment, poor sleep quality and absenteeism. Head of bed elevation, as a low-cost non pharmacologic anti-reflux treatment is nowadays recommended, but its clinical impact in patients with nocturnal symptoms remains unknown due to inconsistent results and methodological limitations among different clinical trials, most of which were performed before the widespread use of proton pump inhibitors in clinical practice. HYPOTHESIS: Head of bed elevation is a useful treatment for patients with gastroesophageal reflux disease and nocturnal symptoms, and has a positive impact in quality of life in these patients. STUDY OBJECTIVE: To assess the effectiveness of head of bed elevation for treatment of patients with gastroesophageal reflux disease and nocturnal symptoms, and to determine the impact of this intervention in quality of life of these patients. METHODS: Randomized single-blind single-centre controlled clinical trial with a 2x2 cross-over design. A sample of 42 patients attending to the outpatient gastroenterology unit at Clínica Fundadores in Bogotá city, who met the inclusion criteria and had no exclusion criteria were selected to participate. Included patients were randomized to raise the head of bed with standard 20 cm-height wooden blocks or to sleep without bed inclination during the first 6 week period. After a 2 week washout period, allocation was crossed and participants were followed again during a second 6 week period. During the trial, every patient received standard pharmacological treatment with a proton pump inhibitor and/or sodium alginate. After allocation concealment, the researchers in charge of statistical analysis and reporting results were blinded for the non pharmacological intervention under study. Primary outcome was a significant symptom change according to Reflux Disease Questionnaire (RDQ) validated form. Secondary outcomes include impact on quality of life according to Short Form 36 (SF-36) validated questionnaire, patient preference and adverse events of non-pharmacological intervention. Statistical analysis was carried out with STATA 13.0 (Special Edition) for Windows. Differences with a p<0,05 were accepted as statistically significant.

NCT ID: NCT02637557 Completed - Clinical trials for Gastroesophageal Reflux Disease

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

Start date: March 1, 2016
Phase: Phase 2
Study type: Interventional

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).