Safety and Efficacy of Dexlansoprazole Modified Release Formulation to Treat Heartburn
Gastroesophageal Reflux DiseaseThe purpose of this study is to assess the efficacy and safety of daily treatment with Dexlansoprazole modified release (MR) (60 mg or 90 mg once daily [QD]) compared to placebo QD in relief of daytime and nighttime heartburn over 4 weeks in subjects with gastroesophageal reflux disease (GERD).
Determination of the Minimal Clinically Important Difference After Treatment With Pantoprazole in...
Gastroesophageal RefluxGastroesophageal reflux disease (GERD) is a medical condition affecting the stomach and esophagus. GERD occurs when the lower esophageal sphincter does not close properly and stomach contents leaks back (refluxes) into the esophagus. GERD is one of the most common medical disorders, with estimates of up to 50% of adults reporting reflux symptoms daily. Proton pump inhibitors such as pantoprazole can relieve symptoms of GERD in a large proportion of patients. Of particular interest in GERD is the assessment of symptom severity and quality of life, and the response of these parameters to treatment. Therefore, a questionnaire to assess GERD symptoms was developed (ReQuest TradeMark). An important point to consider when using such a questionnaire is to evaluate whether an observed difference in scores after a certain treatment represents a clinical effect. The aim of this study is to determine the minimal clinically important difference (MCID) in patients diagnosed with GERD. During the study, the patients will complete a patient-orientated, self-assessed reflux questionnaire (ReQuest TradeMark). Endoscopy will be performed at the start of the study. The study duration consists of a baseline period (1 to 3 weeks) and a treatment period (8 weeks). During the first treatment week, the patients will receive either pantoprazole (tablet) or placebo once daily in the morning; for the following 7 treatment weeks all patients will receive pantoprazole. The study will provide further data on safety and tolerability of pantoprazole.
Study of Pantoprazole for Sleepiness Associated With Acid Reflux and Sleep Apnea
Acid Reflux DiseaseObstructive Sleep ApneaThe purpose of this study is to determine if using Pantoprazole decreases your daytime sleepiness and improves your reaction time when compared to using a placebo (sugar pill).
A Study to Evaluate the Effect of Lansoprazole on Hospitalized Neonates With Gastroesophageal Reflux...
Gastroesophageal Reflux DiseaseThe purpose of this study is to understand how quickly lansoprazole, once daily (QD), improves feeding in premature babies or babies less than 28 days of age.
Economic Impact of Guidelines for Gastroesophageal Reflux Disease
Gastroesophageal Reflux DiseaseHealth EconomicsThis is a series of two prospective studies based on the Department of Veterans Affairs drug treatment guideline for the pharmacologic management of gastroesophageal reflux disease. Our hypothesis is that novel strategies for medical management of gastroesophageal reflux disease (GERD) can decrease resource utilization without adversely affecting patient quality of life. The strategies tested in this project included 1) step-down management, whereby patients rendered asymptomatic on proton pump inhibitors (PPIs) are treated with less expensive medication, and 2) intermittent therapy, defined as administration of medication only for recurrence of GERD symptoms. We chose to examine an intermittent strategy of PPI administration since in addition to the VA guideline requiring step-down therapy, over-the-counter PPIs administered by intermittent therapy became available for use by patients during the study period.
Evaluation of Smectite Effect As A Food Thickener On Gastroesophageal Reflux Disease In Neonates...
Gastroesophageal Reflux in Neonatesstudy of diagnosis of GERD in neonates by MII-PH with trial of smectite for treatment
Prevalence and Predictors of Proton Pump Inhibitor Partial Response in Gastroesophageal Reflux Disease...
Systemic SclerosisGastroesophageal Reflux1 moreProton pump inhibitor (PPI) twice daily dosing regimen-a standard dose therapy for gastroesophageal reflux disease (GERD)-is an effective therapy for uncomplicated GERD in systemic sclerosis (SSc) but there is no data of response rate of standard dose of PPI and predictors of PPI-partial response (PPI-PR) GERD in SSc.Objectives of the study were to determine the prevalence of omeprazole partial response GERD in SSc and to define the predictors of PPI-PR GERD in SSc. Adult SSc patients having GERD were treated with omeprazole 20 mg twice daily 30 minutes before meal for 4 weeks. Severity of symptom-grading by visual analogue scale (VAS) and frequency of symptoms by frequency scale for symptoms of GERD (FSSG) were assessed at baseline and 4 weeks after treatment. PPI-PR GERD was defined by less than 50% improvement in VAS of severity of symptom and acid reflux score by FSSG after treatment compare to baseline.
Study to Evaluate the Efficacy and Safety of DWP14012 in Patients With Erosive Gastroesophageal...
Erosive Gastroesophageal Reflux DiseaseThe purpose of this study is to determine the efficacy and safety of DWP14012 compared to esomeprazole in the treatment of erosive gastroesophageal reflux disease classified as Los Angeles(LA) classification grades A to D.
Impact of Head of Bed Elevation in Symptoms of Patients With Gastroesophageal Reflux Disease
Gastroesophageal Reflux DiseaseBACKGROUND: 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.
To Evaluate Efficacy and Safety of Z-215 in Erosive Esophagitis
EsophagitisRefluxThe purpose of this study is to evaluate the efficacy and safety of Z-215 (10 mg, 20 mg, 40 mg) , compared with Rabeprazole Sodium 10mg in patients with erosive esophagitis of Grade A to D as defined by the LA classification grading system.