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Medical Treatment for Gastroesophageal Reflux Disease (GERD) in Preterm Infants

Cross-over Trial of Medical Treatment for GERD in Preterm Infants

Study Question: In premature infants with apnea and/or bradycardia attributed to gastroesophageal reflux disease (GERD), does treatment with medications (acid blockers and motility agents), compared to placebo, reduce the frequency of apnea and bradycardia? Background: Many clinicians believe that apnea and bradycardia in preterm infants may be caused by gastroesophageal reflux (GER), however, studies have failed to demonstrate even a temporal association between episodes of GER and apnea. There have been no prospective randomized trials of treatment for GERD in preterm infants with apnea or other symptoms attributed to GER. Methods: A randomized, cross-over study will be performed. This cross-over design will provide the patient's clinician with unbiased information about the patient's response to treatment. The clinician can use this information in deciding whether or not to continue treatment after the two-week study period.

NCT00131248 — Gastroesophageal Reflux
Status: Completed
http://inclinicaltrials.com/gastroesophageal-reflux/NCT00131248/

Study of Acid Reflux in Asthma

The Study of Acid Reflux in Asthma

The purpose of this study is to determine if subjects with symptomatic asthma who are assigned to treatment with a proton pump inhibitor (PPI) drug such as Nexium have fewer asthma attacks than similar subjects assigned to placebo treatment.

NCT00069823 — Asthma
Status: Completed
http://inclinicaltrials.com/asthma/NCT00069823/

Medical and Surgical Treatment of Esophageal Reflux

The purpose of this project is to lay the groundwork for a proposed clinical trial to compare the effectiveness of two approaches to gastroesophageal reflux disease: treatment with medications and treatment with anti-reflux surgery. This project includes a non-interventional pilot study to test ways of measuring outcomes of treatment, and to gauge potential participants' willingness to enroll in the proposed clinical trial.

NCT00061724 — Gastroesophageal Reflux
Status: Completed
http://inclinicaltrials.com/gastroesophageal-reflux/NCT00061724/

Economic Impact of Guidelines for Gastroesophageal Reflux Disease

Economic Impact of Guidelines for Gastroesophageal Reflux Disease

This 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.

NCT00057174 — Gastroesophageal Reflux Disease
Status: Completed
http://inclinicaltrials.com/gastroesophageal-reflux-disease/NCT00057174/

Phase III Study of Chondrocyte Alginate Gel Suspension in Pediatric Patients With Vesicoureteral Reflux

OBJECTIVES: I. Determine the safety and efficacy of chondrocyte alginate gel suspension in pediatric patients with vesicoureteral reflux. II. Determine the long term efficacy of this treatment regimen in this patient population. III. Evaluate the short and long term avoidance of surgery or antibiotic therapy after this treatment regimen in this patient population. IV. Estimate the risk:benefit ratio of this treatment regimen in these patients.

NCT00004487 — Vesicoureteral Reflux
Status: Active, not recruiting
http://inclinicaltrials.com/vesicoureteral-reflux/NCT00004487/

GaStroEsophageal effeCt of indobUfen Versus aspiRin in Patients Undergoing Dual antiplatElet Therapy - SECURE

Effect of Indobufen Versus Aspirin on Gastric Acid Secretion and Gastroesophageal Reflux in Patients With Coronary Heart Disease and Gastroesophageal Reflux Disease Undergoing Dual Antiplatelet Therapy: a Prospective, Randomized, Double-blind, Double-dummy, Positive Drug Parallel Control Clinical Trials

The dual antiplatelet therapy based on aspirin plays an important role in the treatment of patients with coronary heart disease. Although aspirin is widely used and effective, it has many limitations in the long-term including increased risk of bleeding. In patients with coronary heart disease and gastroesophageal reflux disease, the symptoms of gastroesophageal reflux are usually aggravated after the application of aspirin. As an antiplatelet drug, indobufen can reversibly and selectively inhibit platelet cyclooxygenase-1 (COX-1), thereby blocking the synthesis of thromboxane B2 (TXB2) and exerting its antiplatelet effect, and it does not affect the production of prostaglandins and endothelial prostacyclins in gastrointestinal mucosa. It has less gastrointestinal injury and lower risk of bleeding. This project is to study the effects of indobufen or aspirin on gastric acid secretion and gastroesophageal reflux in patients with coronary heart disease and gastroesophageal reflux disease treated with dual antiplatelet therapy.

NCT04129008 — Coronary Artery Disease
Status: Not yet recruiting
http://inclinicaltrials.com/coronary-artery-disease/NCT04129008/

Effect of a Combination of Hyaluronic Acid, Chondroitin Sulphate and Magnesium Trisilicate on Subjects With GastroEsophageal Reflux Disease

Effect of a Combination Oral Formulation of Hyaluronic Acid With Chondroitin Sulphate and With Magnesium Trisilicate on Mucosal Integrity and Reflux Exposure in Subjects With Gastro-Esophageal Reflux Disease Not Currently Treated With a Proton Pump Inhibitor: a Double-Blind, Placebo-Controlled, Randomized, Crossover Study

The aim of this study is to investigate whether a 3-week treatment with an oral melt in mouth medical device, made up with hyaluronic acid, chondroitin sulphate and magnesium trisilicate, can lead to a reduction of Gastroesophageal Reflux Disease symptoms and to an improvement of the integrity of esophageal mucosa in patients who are to experiencing esophagus symptoms. The study is a randomized, double-blind cross-over placebo controlled study. Every patient will get both the active study device during one study period and placebo during another another period.

NCT03883074 — Gastro Esophageal Reflux
Status: Completed
http://inclinicaltrials.com/gastro-esophageal-reflux/NCT03883074/

Nexium Capsules S-CEI for Justification of Esomeprazole in Acid Related Disease for Reflux Symptom Healing Based on Patient Clinical Outcomes

NEXIUM Capsule Specific Clinical Experience Investigation (S-CEI) to Investigate Treatment Response to NEXIUM in Patients With Reflux Esophagitis (RE) - Justification of Esomeprazole in Acid Related Disease for Reflux Symptom Healing Based on Patient Clinical Outcomes

The objective of this investigation is to collect following data in patients given NEXIUM capsule (NEXIUM) in usual post-marketing use.

NCT02477475 — Reflux Esophagitis
Status: Completed
http://inclinicaltrials.com/reflux-esophagitis/NCT02477475/

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

A Phase IIa, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Pharmacodynamics of Multiple Dose Levels of Pumosetrag in Patients With Symptoms Associated With Gastroesophageal Reflux Disease (GERD) Receiving a Standard Refluxogenic Meal

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).

NCT01161602 — Gastroesophageal Reflux Disease
Status: Completed
http://inclinicaltrials.com/gastroesophageal-reflux-disease/NCT01161602/

Esomeprazole (NEXIUM) vs. Surgery - LOTUS

An Open, Randomized, Multicenter, Phase IIIB Study During 5 Years to Assess Long-term Efficacy and Tolerability of Esomeprazole Compared to Laparoscopic Anti-reflux Surgery in Adult Subjects With Gastroesophageal reflux Disease - LOTUS.

The study investigates the efficacy of long-term treatment of esomeprazole compared to anti-reflux surgery in the control of gastroesophageal reflux disease by assessing time to treatment failure.

NCT00251927 — Gastroesophageal Reflux
Status: Completed
http://inclinicaltrials.com/gastroesophageal-reflux/NCT00251927/