Laryngopharyngeal Reflux Health Related Quality of Life (LPR-HRQL) Questionnaire Development and Psychometric Testing in Patients Receiving Omeprazole 20 mg Bid as Treatment for Laryngopharyngeal Reflux.
The primary purpose of this study was to establish the psychometric properties of a new disease specific Quality of Life questionnaire, the LPR-HRQL. The specific properties of the questionnaire that were evaluated were: validity, reliability, and responsiveness to change (as a measure of treatment effect).
NCT00641264 — Laryngopharyngeal Reflux (LPR)
Status: Completed
http://inclinicaltrials.com/laryngopharyngeal-reflux-lpr/NCT00641264/
A Multicentre, Randomised, Double-blind, Parallel-group, Comparative Study to Compare the Efficacy and Safety of Esomeprazole 20 mg Once Daily Oral Administration With Omeprazole 10 mg and Esomeprazole 10 mg Once Daily Oral Administration in Maintenance Treatment in Patients With Healed Reflux Esophagitis
The primary objective of this study is to evaluate the efficacy of esomeprazole 20 mg once daily for 24 weeks on maintenance of Reflux Esophagitis in patients with healed reflux esophagitis in comparison with omeprazole 10 mg once daily and esomeprazole 10 mg once daily by assessment of presence/absence of recurrence of Reflux Esophagitis throughout the treatment period (from the randomisation to the treatment completion) according to the Los Angeles classification.
NCT00634114 — Reflux Esophagitis
Status: Completed
http://inclinicaltrials.com/reflux-esophagitis/NCT00634114/
A Multicentre, Randomised, Double-blind, Parallel-group, Comparative Study to Compare the Efficacy and Safety of Esomeprazole 20 mg and 40 mg Once Daily Oral Administration With Omeprazole 20 mg Once Daily Oral Administration in Patients With Reflux Esophagitis
This study is to evaluate the efficacy of esomeprazole 20 mg once daily and 40 mg once daily for 8 weeks on healing of Reflux Esophagitis in patients with reflux esophagitis in comparison with omeprazole 20 mg once daily by assessment of presence/absence of Reflux Esophagitis at Week 8 according to the Los Angeles classification .
NCT00633932 — Reflux Esophagitis
Status: Completed
http://inclinicaltrials.com/reflux-esophagitis/NCT00633932/
A Randomized, Double-Blind, Parallel Group Multicenter Efficacy and Safety Phase IIB Pilot Study of Esomeprazole 40mg Bid Versus Placebo Bid in Adult Asthmatics Treated for 4 Months
The purpose of this study is to assess the efficacy and safety of Nexium in the treatment of subjects with persistent asthma believed to have acid reflux as a contributory factor to control of their asthma.
NCT00628953 — Asthma
Status: Completed
http://inclinicaltrials.com/asthma/NCT00628953/
A Multicenter, Double -Blind, Placebo-controlled Study to Evaluate the Effects of Esomeprazole 40mg Bid on the Signs and Symptoms of Chronic Posterior Laryngitis With Suspected Laryngopharyngeal Reflux
This study looks at how effective acid suppression therapy is on symptoms associated with chronic posterior laryngitis (CPL) in patients with documented pharyngeal acid reflux.
NCT00628667 — Chronic Posterior Laryngitis (CPL)
Status: Completed
http://inclinicaltrials.com/chronic-posterior-laryngitis-cpl/NCT00628667/
Phase III Study on Comparison for Bile Reflux and Gastric Stasis in Patients With Gastric Cancer After Distal Gastrectomy
The purpose of this study is to evaluate the degree of bile reflux and gastric stasis according the reconstruction methods after distal subtotal gastrectomy for gastric cancer, and to find out the proper method. We collect ninety patients who undergo distal gastrectomy for gastric cancers for this study from 5 institutions and randomly divide into 3 groups according to reconstruction methods: 1) Billroth-II (B-II), 2) Roux en Y gastrojejunostomy (RY-GJ) and 3) uncut Roux en Y gastrojejunostomy (uncut RY-GJ).
NCT00622804 — Stomach Cancer
Status: Withdrawn
http://inclinicaltrials.com/stomach-cancer/NCT00622804/
Patient Education in Gastroesophageal Reflux Disease
Patients with gastroesophageal reflux disease (heart-burn, acid regurgitation)may benefit from an educational program explaining the medical aspects of the disease, self-management strategies and how to deal with health services. We hypothesized that patients having participated in an educational program would experience an improved quality of life when compared to patients who did not take part (controls).
NCT00618150 — Gastroesophageal Reflux Disease
Status: Completed
http://inclinicaltrials.com/gastroesophageal-reflux-disease/NCT00618150/
Volume Sensitive Multichannel Intraluminal Impedance (vMII) for the Measurement of Oesophageal Bolus Transport and Reflux
Recent work at St. Thomas' has validated an innovative new design of a multichannel intraluminal impedance (MII) catheter that is sensitive to variation in oesophageal volume in healthy volunteers and patients. This project will establish the clinical value of volume sensitive MII (vMII) compared to conventional MII acquired simultaneously by the same catheter (ROC analysis). Studies will assess: 1. The accuracy of volume measurements and correlation between symptoms and the volume of bolus retention in patients with dysphagia. 2. The accuracy of volume measurements and correlation between symptoms and reflux volume in patients with reflux disease. Follow up studies after appropriate treatment will assess whether symptomatic improvement is associated with a reduction in oesophageal volume retention/reflux. The vMII technique will be applied with high resolution manometry (HRM). These investigations are complementary in that vMII assesses the success or failure of bolus transport (or occurrence of reflux) and HRM can assess: 1. the oesophageal dysfunction that results in bolus escape 2. the abnormal events at the gastro−oesophageal junction (reflux barrier) that allow reflux to occur. with a reduction in oesophageal volume retention / reflux.
NCT00604942 — Achalasia
Status: Terminated
http://inclinicaltrials.com/achalasia/NCT00604942/
Study of Acid Reflux Therapy for Children With Asthma
Gastroesophageal reflux (GER) is frequent in children with asthma, can induce bronchspasm, and increase airway reactivity. Children with asthma are often treated for GER with drugs to supress gastric acid production. However, this treatment is expensive, and with unproven benefit. The primary objective of this study is to conduct a multi-site, randomized, clinical trial to test the hypothesis that treatment of GER with lansoprazole, an approved proton pump inhibitor, will decrease the frequency of exacerbations in children with poorly controlled asthma. The study will include 300 asthmatic children treated with inhaled corticosteroids, 6-16 years of age, with poor control defined by frequent symptoms, excessive beta agonist use, or frequent exacerbations. Participants will be randomly assigned to treatment with either lansoprazole or placebo for 6 months. The presence, severity, and relationship of GER to asthma symptoms will be determined with 24 hour esophageal pH monitoring, but randomization to treatment will not be influenced by the presence or severity of GER. The primary outcome measure is the proportion of participants who have exacerbations of asthma defined by diaries and interviews. Secondary outcome measures include asthma symptom and control scores, GER symptoms, lung function, and unscheduled health care contacts. Pre-defined subgroup analyses will examine the relationship between specific clinical features and the response to lansoprazole. Treatment response will also be evaluated with 3-hour post-dose plasma lansoprazole concentrations, and related to polymorphisms in the gene CYP2C19, the cytochrome P450 pathway, and interleukin-1 (IL-1) beta, a pro-inflammatory cytokine. Tertiary studies will determine how the magnitude of GER impacts airways inflammation, as measured by the concentrations of hydrogen ions (pH) and nitric oxide in expired breath. The results of this trial sould have a major impact on the understanding and treatment of GER in children with asthma.
NCT00604851 — Asthma
Status: Completed
http://inclinicaltrials.com/asthma/NCT00604851/
Confocal Laser Microscopy in Non Erosive Reflux Disease
Heartburn or reflux disease affects about 20% of Americans. 50 - 70% of people who have endoscopy for reflux disease have a normal appearing esophagus. Confocal Laser Microscopy allows us to see changes in the cells not visable during routine endoscopy. Whe goal of this study is to identify the use of this new technique in diagnosing reflux in patients who have normal appearing esophagus.
NCT00588939 — Heartburn
Status: Completed
http://inclinicaltrials.com/heartburn/NCT00588939/