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Gastroesophageal Reflux clinical trials

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NCT ID: NCT00165646 Completed - Clinical trials for Non-erosive Gastroesophageal Reflux Disease

A Comparative Study on the Efficacy and Safety of E3810 in Patients With Non-erosive Gastroesophageal Reflux Disease

Start date: September 2004
Phase: Phase 3
Study type: Interventional

To investigate the efficacy and safety of a 4-week treatment of 5 mg/day or 10 mg/day of E3810 (Pariet (Rabeprazole Sodium)) in patients with non-erosive gastroesophageal reflux disease in a multicenter, randomized, double-blind, comparative study.

NCT ID: NCT00165022 Completed - Clinical trials for Gastroesophageal Reflux Disease

Development of a Novel Disease-Specific Quality of Life Questionnaire for Gastroesophageal Reflux Disease (GERD) Patients in Chinese Population

Start date: September 2003
Phase: N/A
Study type: Observational

A questionnaire composed of items addressing psychological, emotional and social aspects of GERD is developed for Chinese population. We plan to conduct a validation study on this novel disease-specific quality of life (QoL) instrument. This study aims to evaluate various indicators of validity and reliability, which include criterion validity, test-retest reliability, responsiveness, internal consistency reliability and discriminant validity. After initial pilot testing of face validity and content validity, two hundred GERD patients from the gastroenterology and ulcer clinics of cluster NTE hospitals will be invited to complete a revised 18-item version of GERD-QOL questionnaire. The data from GERD QOL will be evaluated using exploratory factor analysis to identify appropriate items and domains and the internal consistency of the domains will be determined and further refinement of questionnaire will follow. 100 GERD patients will complete GERD-QOL, SF-36 health survey and the visual analog scale (VAS) questionnaire for criterion validation. 100 GERD patients with stable symptom profile will repeat GERD QOL two weeks after the first administration for evaluation of test-retest reliability. Another 26 patients who are receiving maintenance acid suppressive therapy and in remission of symptom will be recruited as controls for comparison with active reflux patients. The ability to distinguish active patients from controls in remission is known as discriminant validity.

NCT ID: NCT00164840 Completed - Clinical trials for Gastroesophageal Reflux Disease

Symptomatic Gastroesophageal Reflux Disease: Double Blind Randomized Controlled Study of On-demand Therapy Versus Maintenance Therapy

Start date: May 2003
Phase: Phase 3
Study type: Interventional

Maintenance treatment with proton pump inhibitor (PPI) is the most widely recommended modality of treatment for long-term management of gastroesophageal reflux disease (GERD). Yet in clinical practice treatment is commonly given in short courses on as required basis during symptom flare up, particularly for patients with mild to moderate GERD. On-demand therapy also has the potential advantage that patient does not need to take regular medications, thereby improving the quality of life. However, whether on-demand PPI therapy achieves similar efficacy of symptom control is uncertain. The aim of this study is to compare the efficacy and quality of life of on-demand and maintenance PPI regimens in long-term management of non-erosive GERD patients. The investigators hypothesize that on-demand PPI treatment is as effective as maintenance PPI.

NCT ID: NCT00164814 Terminated - Clinical trials for Non-Cardiac Chest Pain

The Role of Visceral Hyperalgesia, Gastroesophageal Reflux Disease (GERD) and Esophageal Motility Disorder (EMD) in NCCP Patients

Start date: n/a
Phase: N/A
Study type: Observational

Noncardiac chest pain (NCCP) is a common clinical problem worldwide. In Hong Kong, it has been estimated that about 20% of patients with chest pain are misdiagnosed to have coronary heart disease. Despite its benign nature, this condition causes anxiety, impairs quality of life and consumes a substantial amount of healthcare resources. While acid reflux and motility disorder in the esophagus are often attributed as the cause of NCCP, visceral hyperalgesia of esophagus is now recognized to play a central role in the pathogenesis of this condition. This research project aims to evaluate the role of visceral hyperalgesia in Chinese patients with NCCP. NCCP patients will be evaluated for the prevalence of gastroesophageal reflux disease and esophageal motility disorder by endoscopy, manometry and pH study. The visceral sensory and pain thresholds of these patients will be compared with asymptomatic controls.

NCT ID: NCT00164021 Recruiting - Cystic Fibrosis Clinical Trials

The Prevalence and Significance of Gastro-oesophageal Reflux in Cystic Fibrosis Before and After Lung Transplantation

Start date: February 2001
Phase: N/A
Study type: Observational

Gastro-oesophageal reflux (GOR) has been found to be prevalent in children with cystic fibrosis (CF)and may further worsen lung damage via reflex bronchospasm or pulmonary aspiration. Chest physiotherapy may result in increased episodes of GOR as demonstrated in children. Lung transplantation may worsen pre-existing GOR. This study will determine the prevalence, severity and significance of symptomatic and silent GOR in adults with CF before and after lung transplant using 24hr oesophageal pH monitoring, a valid symptom questionnaire, quality of life questionnaires and gastric emptying studies. This study will identify the extent of GOR in a large adult CF population and the impact on lung function and quality of life together with the effects of medical and physiotherapy treatment on gastro-oesophageal function.

NCT ID: NCT00163306 Completed - Clinical trials for Gastroesophageal Reflux

Efficacy of Pantoprazole in Patients Older Than 18 Years Who Have Symptoms of Acid Reflux (Gastroesophageal Reflux Disease) (BY1023/M3-339)

Start date: May 2005
Phase: Phase 3
Study type: Interventional

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 symptoms related to gastric reflux. Proton pump inhibitors (PPI) such as pantoprazole can relieve symptoms of GERD in a large proportion of patients. When refluxed stomach acidic content touches the lining of the esophagus, it causes a burning sensation in the chest or throat. This sensation is often referred to as heartburn. Some patients have symptoms of GERD without visible destruction of the tissue surface (no visible changes by endoscopic examination). The aim of the study is to evaluate the effect of pantoprazole on the complete remission of GERD. Complete remission is defined as endoscopically confirmed healing and symptom relief after a maximum of 12-week treatment period. Pantoprazole will be administered once daily in the morning. Endoscopy will be performed at the start of the study, and then as required after 4, 8, or 12 weeks. The study will provide further data on safety and tolerability of pantoprazole.

NCT ID: NCT00155805 Recruiting - Hiatal Hernia Clinical Trials

Immunologic Factors in Reflux Esophagitis and Barrett’s Esophagus

Start date: February 2004
Phase: N/A
Study type: Observational

By using combination of the expression of COX-2 and NOS and immunologic reaction in the esophagus with manometry of LES and cruel diaphragm and 24 hr esophageal pH monitoring to investigate the mechanisms and to make a new and more clinically applicable clarification of these reflux diseases will be valuable in the clinical management and prevention. We will perform the following works and complete the objectives: 1) comparing the difference of immuno-inflammatory reactions among NERD, reflux esophagitis and Barrett’s esophagus; 2) the different expression of PGs & COX-2 in functional heartburn, hiatus hernia, NERD, reflux disease and Barrett’s esophagus; determining the subtype of EP receptor (EP1~4); 3) determining and comparing the expression of NOS in the esophagus; 4) investigating the role of ROS in the esophagus; 5) in correlating cytokine, COX-2 and NOS with LESP, TLESR, diaphragm EMG and 24-hour esophageal pH ; 6) the difference of expression of cytokine, atrophic gastritis and Hp in gastric mucosa, in correlating with intragastric acid status, among functional heartburn, hiatus hernia, NERD, erosive esophagitis and Barrett’s esophagus; to determine whether should eradicate Hp in reflux esophageal disease; 7) the effects of lipid peroxidation related immunologic reaction, with relation to COX-2 and NOS, in the inflammatory activity and esophageal carcinogenesis of esophagus; 8) the effects of cytokines, COX-2 and NOS on the apoptosis in these reflux esophageal diseases; 9) integrating immuno-inflamatory reaction, COX-2, NOS with manometry of LES and diaphragm, and 24-hour pH monitoring and intragastric pH to newly clarify GERD into evidence based categories.

NCT ID: NCT00154570 Recruiting - Reflux Esophagitis Clinical Trials

24 Hour Esophageal and Electrogastrography to Investigate the Mechanism of Reflux Esophagitis

Start date: February 2004
Phase: N/A
Study type: Observational

We hypothesize that gastric dysrhythmias may predispose the occurrence of gastroesophageal reflux.

NCT ID: NCT00149851 Completed - Clinical trials for Symptomatic Gastroespohageal Reflux Disease

A Study to Assess the Efficacy, Safety and Tolerability of Tegaserod Alone and in Combination With Omeprazole Given Orally in Patients With Symptoms of Symptomatic Gastroesophageal Reflux Disease (sGERD)

Start date: January 2004
Phase: Phase 2
Study type: Interventional

Gastroesophageal Reflux Disease (GERD) is a common disorder caused by the reflux of gastric (stomach) acid into the esophagus. The exposure of the lining of the esophagus to the acid will cause damage to the esophagus over time. The symptoms of GERD include heartburn and acid regurgitation This study will determine if Tegaserod alone and in combination with omeprazole is safe and relieves the symptoms of heartburn.

NCT ID: NCT00141960 Completed - Clinical trials for Gastroesophageal Reflux

Famotidine in Subjects With Non-erosive Gastroesophageal Reflux Disease

Start date: September 2005
Phase: Phase 2/Phase 3
Study type: Interventional

Gastroesophageal reflux disease (GERD) considered to be associated with mucosal damages in the esophagus and heartburn, which may sometimes interfere with daily activities due likely to reflux of acid gastric contents. While most of the patients given the diagnosis of GERD do not exhibit endoscopically obvious impairment in esophageal mucous membrane, they have subjective symptoms of non-erosive GERD including heartburn. But no drug has been launched in Japan, which targets non-erosive GERD. This study will examine the efficacy and safety of famotidine in subjects with non-erosive GERD.