A Double-blind, Randomised, Parallel-group, Multicentre, Phase III Study to Compare the Efficacy of Omeprazole 20mg and 10mg od for the Four-week Treatment of Non-erosive Reflux Disease (NERD) With That of Placebo od and to Investigate Safety
The purpose of this study is to study safety and efficacy of omeprazole standard treatment in a Japanese non-erosive reflux disease population.
NCT00259077 — Non-erosive Reflux Disease
Status: Completed
http://inclinicaltrials.com/non-erosive-reflux-disease/NCT00259077/
Determination of the Minimal Clinically Important Difference (MCID) of the Patient Orientated Self Assessment Scale ReQuest TradeMark in Patients Suffering From Endoscopically Confirmed Gastroesophageal Reflux Disease (GERD), Grade A-D According to Los Angeles Classification Treated With Pantoprazole 40 mg o.d. or Placebo o.d. Over One Week.
Gastroesophageal 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.
NCT00246909 — Gastroesophageal Reflux
Status: Completed
http://inclinicaltrials.com/gastroesophageal-reflux/NCT00246909/
A Randomized, Double-Blind, Placebo-Controlled Study of Gastroesophageal Reflux Disease Therapy ( Lansoprazole; Solutab) in the Management of Childhood Asthma
Asthma and gastroesophageal reflux disease (GERD) are common disorders, which although are not usually lethal, both have high morbidity, and high healthcare costs. Recent studies have demonstrated that asthma and GERD often co-exists, and that this co-existence is more frequent than just chance. Therefore, studies that characterize associations between these conditions, and, help in the development of interventions will positively impact the outcomes of these patients, which are critically needed. Subjects that participate in this study are required to be between the ages of 4-11 years old. This protocol proposes to enroll 100 children with asthma, on inhaled steroids who have poor asthma control, defined on the basis of frequent symptoms, excessive beta-agonists use, or frequent asthma episodes. The purpose of this research study is to: 1. Determine, whether children with symptomatic, poorly controlled, asthma assigned to treatment with a PPI( Proton Pump Inhibitor), have fewer asthma exacerbations than similar participants assigned to placebo for a similar duration of time 2. Determine whether children treated with Lansoprazole ( i.e., proton pump inhibitor): have a longer time to first exacerbation, have improved lung function, improved asthma symptom scores, improved quality of life, decreased rescue inhaler use, or other asthma medications, reduced emergency room/urgent care/ physician office visits that are asthma related. 3. Determine whether a subgroup of symptomatic asthmatics, who show a greater benefit from PPI's, can be identified.
NCT00237068 — Asthma
Status: Active, not recruiting
http://inclinicaltrials.com/asthma/NCT00237068/
A Blinded, Randomized, Sham-Controlled Trial of Endoscopic Gastroplication for the Treatment of Gastroesophageal Reflux Disease
Aim: To evaluate the therapeutic efficacy of a therapeutic procedure, involving endoscopic suturing, for gastroesophageal reflux disease (GERD) compared to a sham procedure. The hypotheses tested in this study were that active treatment would: 1) decrease the use of antisecretory medication, 2) decrease GERD symptoms, 3) improve quality of life, and 4) reduce esophageal acid exposure.
NCT00235677 — Gastroesophageal Reflux
Status: Completed
http://inclinicaltrials.com/gastroesophageal-reflux/NCT00235677/
Overall Assessment of Improvement in Bronchial Asthma Patients With Extraesophageal Reflux After Effective Acid Suppression
The purpose of this study is to determine if 20mg BID of Rabeprazole is effective in controlling GERD in patients with concomitant bronchial asthma and to assess improvement in asthma after reflux control.
NCT00234117 — Gastroesophageal Reflux
Status: Completed
http://inclinicaltrials.com/gastroesophageal-reflux/NCT00234117/
Functional and Molecular Characterisation of Oesophageal Distal Epithelium: Correlations With Acid and Non Acid Reflux
This study aims to characterize the permeability as well as some protein involved in the cell junction in the oesophageal epithelium in patients with GORD symptoms. In addition these patients will be characterized for their reflux especially by pH-impedancemetry, Bilitec and oesophageal acid perfusion test. Correlations between the characteristics of the reflux and the biological results will be calculated.
NCT00231881 — Gastroesophageal Reflux
Status: Recruiting
http://inclinicaltrials.com/gastroesophageal-reflux/NCT00231881/
Verification Study on Lafutidine in Mild Reflux Oesophagitis - Double Blind Controlled Study With Famotidine -
The purpose of the study is to verify superiority of the lafutidine group over the placebo group and non-inferiority to the famotidine group in terms of endoscopic healing rate of the patients with mild reflux oesophagitis. Furthermore, the followings are compared: The improvement effect in heartburn and other subjective symptoms, and dosing frequency of MALFA ® suspension (neutralizer) as well as incidence of adverse events among the lafutidine 20 mg/day treatment group, the famotidine 40 mg/day treatment group and the placebo treatment group in patients with mild reflux oesophagitis.
NCT00229424 — Gastroesophageal Reflux
Status: Completed
http://inclinicaltrials.com/gastroesophageal-reflux/NCT00229424/
Rectal and Oral Omeprazole Treatment of Gastroesophageal Reflux in Infants With Esophageal Atresia or Congenital Diaphragmatic Hernia; A Pharmacodynamic and Pharmacokinetic Study.
The purpose of this study is to compare the efficacy of oral and rectal omeprazole treatment in infants with gastroesophageal reflux due to esophageal atresia or congenital diaphragmatic hernia.
NCT00226044 — Gastroesophageal Reflux
Status: Completed
http://inclinicaltrials.com/gastroesophageal-reflux/NCT00226044/
Esophagoprotection by Rabeprazole Mediated by Restoration of an Impairment in Esophageal Mucin Production: Its Potential Therapeutic Benefit in Patients With Gastroesophageal Reflux Disease (GERD)
The purpose of this study is to determine the production of mucin in GERD/RE subjects before and after 8 weeks of treatment with rabeprazole.
NCT00222170 — Esophageal Reflux
Status: Completed
http://inclinicaltrials.com/esophageal-reflux/NCT00222170/
A Phase 1, Single- and Repeated-Dose, Randomized, Open-Label, Multicenter Study to Evaluate the Pharmacokinetics, Pharmacodynamics and Safety of Lansoprazole in Infants With Clinically-Evident Gastroesophageal Reflux Disease.
The 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.
NCT00220818 — Gastroesophageal Reflux Disease
Status: Completed
http://inclinicaltrials.com/gastroesophageal-reflux-disease/NCT00220818/