Supplementary Study of Hull Airway Reflux Questionnaire Scores Before and After Treatment Study: A Multicentre, Double-Blind, Placebo-Controlled, Pivotal Study of the Efficacy and Safety of Oral Theobromine in the Management of Cough."
The aim of this study is to have those patients taking part in the Clinical trial-: A Multicentre, Double-Blind, Placebo-Controlled, Pivotal Study of the Efficacy and Safety of Oral Theobromine in the Management of Cough. Complete the Hull Airway Reflux Questionnaire (HARQ) at randomisation and repeat the questionnaire at the end of the 14 day treatment period. The investigators hope to demonstrate a clinically significant change in HARQ scores of at least 16 points from before and after treatment. Furthermore the investigators would hope to show a significantly improved HARQ score in patients on the BC036 arm of the study compared to the placebo arm.
NCT01515280 — Cough
Status: Completed
http://inclinicaltrials.com/cough/NCT01515280/
Diagnostic Value of Narrow-band Imaging, Autofluorescence Imaging & White-light Imaging on Gastroesophageal Reflux Disease
Aim of this study is to compare the efficacy of narrow band imaging (NBI) and autofluorescence imaging (AFI) to distinguish subtle mucosal change related to acid reflux that is not visible in standard white light imaging (WLI) endoscopy, and help indicating the diagnosis of gastroesophageal reflux disease (GERD).
NCT01504971 — Gastroesophageal Reflux Disease
Status: Active, not recruiting
http://inclinicaltrials.com/gastroesophageal-reflux-disease/NCT01504971/
A Phase 3, Randomized, Double Blind, Placebo Control, Multicenter Study to Evaluate the Efficacy and Safety of TAK- 438 (10 and 20 mg Once-Daily) in Patients With Non-Erosive Gastroesophageal Reflux Disease.
The purpose of this study is to investigate the superiority of efficacy of TAK-438, once daily (QD), to placebo in patients with non-erosive gastroesophageal reflux disease.
NCT01474369 — Non-erosive Gastroesophageal Reflux Disease
Status: Completed
http://inclinicaltrials.com/non-erosive-gastroesophageal-reflux-disease/NCT01474369/
This is a prospective study to extensively evaluate subjective patient parameters on quality of life, reflux-symptoms, side effects, medication-use and measurements of esophageal manometry and Impedance-pH-Monitoring after Full-Thickness-Gastroplication.
NCT01453985 — Gastroesophageal Reflux Disease
Status: Recruiting
http://inclinicaltrials.com/gastroesophageal-reflux-disease/NCT01453985/
A Double-blind, Randomized, Placebo-controlled Study to Evaluate the Efficacy and Safety of Alginos Oral Suspension (Sodium Alginate 50 mg/ml) for the Treatment of Patients With Laryngopharyngeal Reflux (LPR)
Laryngopharyngeal reflux (LPR), the backflow of gastric acid into the larynx and hypopharynx, is a contributing factor to hoarseness, throat clearing, throat pain, and globus sensation. The therapeutic effect of proton pump inhibitors (PPIs) is controversial because a high placebo effect can be observed. Sodium Alginate is an effective medication indicated for symptomatic treatment of gastroesophageal reflux. This randomized, double-blind, placebo-controlled study aims to evaluate the efficacy and safety profile of sodium alginates oral suspension (50 mg/ml) 20 ml 3 times daily for the treatment of with LPR patients in Taiwan. Efficacy assessments include mean reduction in the total reflux symptom index (RSI) score after 4 and 8 weeks treatment, mean reduction in the total reflux finding score (RFS) after 4 and 8 weeks treatment, mean changes in the total numbers of reflux episodes as measured by 24-hour ambulatory combined impedance-pH monitoring after 1 day and 8 weeks treatment. Safety assessments include incidence of adverse events. The study hypothesis is sodium alginate is superior over placebo in relieving LPR symptoms.
NCT01450748 — Laryngopharyngeal Reflux
Status: Completed
http://inclinicaltrials.com/laryngopharyngeal-reflux/NCT01450748/
A Prospective, Observational Study to Describe Symptom Control and Impact on Daily Life in Patients With Gastroesophageal Reflux Disease (GERD)
The purpose of this study is to evaluate the impact of gastroesophageal reflux disease (GERD) treatment in primary care setting on symptom control and daily life in symptomatic GERD patients, using both GERD questionnaire and clinical symptoms assessment
NCT01432392 — Gastroesophageal Reflux Disease
Status: Completed
http://inclinicaltrials.com/gastroesophageal-reflux-disease/NCT01432392/
Prospective and Retrospective Study to Develop a Multi-center Randomized Study, to Determine if Prevention of GERD Related Aspiration by Surgical Fundoplication Improves Lung Allograft Function
The purpose of the prospective study is to collect information surrounding lung transplant in order to develop a randomized study to determine if prevention of gastroesophageal reflux disease (GERD) related aspiration (stomach acid coming up from the stomach into the esophagus) by surgical fundoplication improves lung rejection. Lung transplantation has evolved into an effective treatment for patients with end-stage lung disease; however, a significant limitation to long-term survival is patients develop a condition of scarring known as chronic lung rejection, which can cause lung function to deteriorate, thereby reducing a patient's chances for survival. Preliminary research has shown a correlation between the presence of gastroesophageal reflux disease (GERD) and impaired early lung rejection as assessed by a breathing test, FEV1 (the amount of forced expired air volume in 1 second). The Investigator is interested in learning more about this condition and the potential for aspiration (inhaling fluid) injury. The primary goal of this preliminary study will be to identify aspiration markers that are correlated with adverse clinical outcomes (increased early rejection, decreased FEV1) that may be used as inclusion criteria for the future randomized trial. The purpose of the retrospective study is to collect information surrounding lung transplant in order to develop a randomized study to determine if prevention of gastroesophageal reflux disease (GERD) related aspiration (stomach acid coming up from the stomach into the esophagus) by surgical fundoplication improves lung rejection. The goal of this retrospective data collection is to review the following: 1. subject outcome event rates for subjects with and without gastroesophageal reflux disease (GERD) for survival, Bronchiolitis Obliterans Syndrome (BOS), acute rejection and Forced Expiratory Volume in the first second (FEV-1), 2. the estimated treatment effect of fundoplication on the above event rates, 3. a threshold effect for Bronchiolitis Obliterans Syndrome (BOS) and/or death are more likely to occur at higher or more proximal acid or non-acid contact times. This data will be collected in order to better design and coordinate a multicenter prospective study.
NCT01406210 — Gastroesophageal Reflux Disease (GERD)
Status: Completed
http://inclinicaltrials.com/gastroesophageal-reflux-disease-gerd/NCT01406210/
Double Blinded, Randomized, Active Drug Comparative, Therapeutic Confirmatory Clinical Study to Evaluate the Efficacy and Safety of AGSPT201 in GERD Patients
The purpose of this study is to evaluate treatment in Gastroesophageal Reflux Disease (GERD) patients (aged 18~75) with endoscopically proven GERD treated with AGSPT201 Tablet.
NCT01400945 — Gastroesophageal Reflux Disease
Status: Completed
http://inclinicaltrials.com/gastroesophageal-reflux-disease/NCT01400945/
Salivary Epidermal Growth Factor (EGF) Concentration Before and After Treatment of Reflux Laryngitis: Final Results
- Saliva plays a key role in the homeostasis of the digestive tract - The reflux of gastroesophageal contents may cause damage to the esophageal, laryngeal and pharyngeal mucosas - There seems to be no correlation between the severity of reflux episodes and the intensity of inflammatory changes, suggesting individual protective mechanisms to refluxate exposure - Inorganic and Organic Salivary changes have been associated to Gastroesophageal Reflux Disease (GERD) and its supraesophageal manifestations, especially reflux laryngitis (Laryngopharyngeal Reflux- LPR) - Decreased salivary Epidermal Growth factor (EGF) concentrations have been found in patients with GERD and LPR, but it is unclear if these are primary or secondary to the disease. - Hypothesis: The decreased salivary EGF concentrations in patients with reflux laryngitis is primary and therefore would not change after treatment and control of the disease
NCT01389401 — Gastroesophageal Reflux Disease (GERD)
Status: Completed
http://inclinicaltrials.com/gastroesophageal-reflux-disease-gerd/NCT01389401/
A Prospective Randomized Controlled Trial of the Efficacy of i-Scan for Detecting Reflux Esophagitis
Endoscopy is a widely used modality for the diagnosis and classification of Gastroesophageal reflux disease (GERD), and the extent of esophageal mucosal breaks on endoscopy can be assessed. However, there were some limitation in diagnosis of GERD using endoscopy 1. More than half of patients with GERD reveal no visible abnormality on conventional endoscopy, it is possible that minute mucosal changes are underestimated by conventional endoscopy due to the limitation of visual ability 2. In addition of uncertainty in detecting mucosal breaks, uncertainty in describing severity of mucosal injury can lead to inconsistency among interpreters. Interobserver agreement regarding diagnosis and classification of GERD using endoscopy is unsatisfactory to apply daily practice. Thus, the development of a new method to define the intra-esophageal injury for use in daily practice is a worthwhile endeavor and developed, such as narrow−band imaging (NBI), Fuji Intelligent Chromoen−doscopy (FICE) and i-scan. Among them, i-scan technology is the most recently developed image enhancing technology, which consists of three modes of image enhancement, i.e. surface enhancement (SE), contrast enhancement (CE), and tone enhancement (TE). Thus, the investigators examined the hypothesis that i-scan can improve the detection rate of reflux esophagitis and inter-observer agreement between endoscopists compared with conventional white light (WL) endoscopic examination.
NCT01381991 — Gastroesophageal Reflux Disease
Status: Completed
http://inclinicaltrials.com/gastroesophageal-reflux-disease/NCT01381991/