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GERD clinical trials

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NCT ID: NCT01887743 Completed - Obesity Clinical Trials

Pharmacokinetics of Pantoprazole and CYP2C19 Activity in Children and Adolescents With GERD: A Pilot Study

Start date: June 2013
Phase: Phase 1
Study type: Interventional

The World Health Organization has declared childhood obesity to be "one of the most serious public health challenges of the 21st century," (http://www.who.int/dietphysicalactivity/childhood). Given that obese children are generally excluded from clinical trials, little to no information exists regarding the impact of obesity on drug disposition and drug action, creating a gap in physicians' knowledge on how to appropriately select the dose of many critical medications (e.g., anticancer agents), so as to prevent toxicity associated with overdosing, while avoiding the harms of under-treatment. The proposed study will examine the effect of obesity on the metabolism of a commonly used medication, the proton pump inhibitor pantoprazole, by exploring the relationships between age, obesity, basal metabolic rate and genetic control of the enzyme primarily responsible for pantoprazole metabolism. We will also validate a simple breath test that can be used to predict pantoprazole dose requirement for obese children. The study is designed to test the following experimental hypotheses:[13C]-pantoprazole pharmacokinetic parameters are not different between non-obese and obese children and adolescents, collectively (both age groups combined) or stratified by age group (SA 1) [13C]-pantoprazole pharmacokinetic parameters or DOB values (and thus, CYP2C19 activity) are not different between males and females (SA 1 & 2) [13C]-pantoprazole pharmacokinetic parameters and DOB (Delta over baseline) values (and thus, CYP2C19 activity) are independent of age over the age range of 6 to 17 years (SA 1 & 2) Obesity does not alter the relative contributions of CYP2C19-dependent and non-CYP2C19-dependent (i.e., CYP3A4) metabolism of pantoprazole, as measured by the urinary ratio of 4-hydroxy-pantoprazole to pantoprazole sulfone (SA 1 & 2) The [13C]-pantoprazole breath test, by determining DOB at discrete time point(s), is a non-invasive measure of CYP2C19 phenotype (SA 2) Clearance of pantoprazole (surrogate for CYP2C19 activity) is a function of REE in obese and non-obese children and adolescents (SA 3) Pantoprazole clearance (surrogate for CYP2C19 activity) is associated with fat distribution, as determined by waist-to-hip ratios (SA 3)

NCT ID: NCT01710800 Completed - GERD Clinical Trials

Twenty-Four Hour Combined Multi-Channel Impedance and pH Ambulatory Monitoring: Impedance Reflux Episodes of Patients On and Off Proton Pump Inhibitor Therapy

Start date: September 2008
Phase: N/A
Study type: Interventional

The purpose of this study is to determine the effects of proton pump inhibitors (PPIs) on the total number of reflux episodes in the distal esophagus measured by impedance in patients with and without gastroesophageal reflux disease (GERD) based on 24-hour pH testing. In addition to changing the acidity of the refluxate, the investigators hypothesize that PPIs also reduce the total number of reflux episodes due to its anti-secretory effects.

NCT ID: NCT01707901 Completed - GERD Clinical Trials

A Study of the Effect of ONO-8539 on Oesophageal Pain Hypersensitivity in Patients With Non-erosive Reflux Disease

Start date: December 2012
Phase: Phase 1
Study type: Interventional

A random controlled study to investigate the effect of a new drug, ONO-8539, on oesophageal pain hypersensitivity in patients with gastric reflux disease

NCT ID: NCT01657578 Completed - Clinical trials for Gastroesophageal Reflux Disease (GERD)

Optimal Dosing of Omeprazole in Neonates

OMEPRAZOLE-1
Start date: June 2007
Phase: Phase 2
Study type: Interventional

"The principal aim of this trial is to determine the minimum effective dose of omeprazole in neonates with GERD objectively diagnosed by a 24-h intra-oesophageal pH monitoring (pHmetry), to obtain a short-term efficacy in the pHmetry of control performed 72 hrs ± 24 after initiation of omeprazole. The secondary objectives of the study were: (1) to assess the efficacy of omeprazole upon other pHmetry parameters, (2) to characterize the population pharmacokinetics and pharmacogenetics of omeprazole, (3) to evaluate the effect of omeprazole upon oro-pharyngeal pH monitoring and (4) to assess the short-term safety of use of omeprazole in neonates."

NCT ID: NCT01647958 Completed - Clinical trials for Gastroesophageal Reflux Disease (GERD)

The EndoGastric Solutions TEMPO Trial

TEMPO
Start date: June 1, 2012
Phase: N/A
Study type: Interventional

The purpose of this study is to assess the efficacy and safety of Transoral Incisionless Fundoplication (TIF) performed with EsophyX as compared to proton pump inhibitor (PPI) therapy for the treatment of chronic Gastroesophageal Reflux Disease (GERD) patients with refractory symptoms on Proton Pump Inhibitors (PPIs).

NCT ID: NCT01624506 Completed - Clinical trials for Gastroesophageal Reflux

Observational Study of Anti-Reflux Surgery

Start date: January 2010
Phase:
Study type: Observational

The Anti-Reflux Surgical Study has been established to: - Collect data about anti-reflux surgical treatment options (magnetic sphincter augmentation and Fundoplication) in everyday clinical practice - Track the clinical course of patients from pre-operative assessment to three years post-surgery

NCT ID: NCT01606449 Completed - Clinical trials for Paraesophageal Hernia

Follow-up of Patients Operated Upon for Type II-IV Hiatal Hernia

Start date: January 1980
Phase: N/A
Study type: Observational

Surgical therapy for gastroesophageal reflux disease (GERD) and hiatal hernia (HH) can achieve outcomes that afford the patient lifelong satisfaction. The published results obtained with this surgery may not be considered to be definitive in relation to the length of follow-up or patients' life expectancy. The real recurrence rates and the results of surgery for GERD are difficult to assess due to the lack of serial time points during the follow-up. Further bias may have been introduced into the analysis by a lack of appropriate controls. The results of surgical therapy for type II-IV HH are even more controversial because of the high rate of anatomical relapse and the different methods of follow-up adopted in reported case series. Aim of this study is to clarify the value of surgical therapy for type II-IV HH. The investigators report on patients who were followed up after surgery at various time points over the course of 30 years.

NCT ID: NCT01601379 Completed - Clinical trials for Gastroesophageal Reflux Disease

Observational Study (This Means That no Drug is Tested) in Patients Suffering of Gastroesophageal Reflux Disease.

PROFILE
Start date: June 2010
Phase: Phase 4
Study type: Observational

The purpose of this observational study (this means that no drug is being tested in this study) is to obtain updated and detailed information about the Gastroesophageal Reflux Disease (GERD) specificities in European patients. The information about patients suffering from typical GERD symptoms will be collected in order to establish a classification of adult patients profile based on the characteristics of GERD symptoms. This study will only involve data collection about the disease. The treatment will not be affected by the study.

NCT ID: NCT01570842 Completed - Clinical trials for Gastroesophageal Reflux Disease (GERD)

Anthropometry in Gastroesophageal Reflux Disease and Esophageal Injury

Start date: October 2011
Phase: N/A
Study type: Interventional

Is waist to hip ratio (WHR), waist circumference (WC), (as markers of visceral adiposity) associated with an increase in acidic and non acidic reflux as well as systemic inflammation involving esophageal mucosa, thereby increasing esophageal injury and predisposing to subsequent development of Barrett's esophagus (BE)?

NCT ID: NCT01556919 Completed - GERD Clinical Trials

Esophageal Monitoring Device for Assessing Mucosal Impedance

Start date: March 2012
Phase:
Study type: Observational

The investigators are looking at a novel approach to measuring gastroesophageal reflux disease (GERD) damage and reducing the need for costly and less optimal testing presently used for diagnostic and treatment purposes. The investigators will be using three custom mucosal impedance (MI) catheters, each designed to measure at slightly different spacing on the esophagus.