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GERD clinical trials

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NCT ID: NCT00586963 Completed - GERD Clinical Trials

Proton Pump Inhibitor (PPI) Therapy for Newly Diagnosed Esophagitis

EE
Start date: January 2008
Phase: N/A
Study type: Observational

This study is being done to for two reasons: - To learn about the effects (good and bad) esomeprazole (an FDA approved drug for reflux esophagitis) has on your esophagus when taken correctly. - To learn about the quality of life changes (good and bad) you may experience with this medication.

NCT ID: NCT00586859 Terminated - GERD Clinical Trials

Multi-Center Study of the NDO Surgical Plicator Utilizing Multiple Implants for the Treatment of GERD

Start date: May 2006
Phase: N/A
Study type: Interventional

The purpose of this study was to evaluate the safety and efficacy of placing multiple transmural sutures for the treatment of GERD. A prospective, multi-center, open-label trial was conducted at four centers in Germany to evaluate a modified Plicator technique for the treatment of patients with symptomatic GERD. Primary efficacy was based on analysis of the GERD Health Related Qualify of Life (HRQL) questionnaire at 6-months post-treatment. Additional efficacy outcomes assessed were heartburn and regurgitation symptoms scores, visual analog scale (VAS) score, GERD medication use, esophageal pH/manometry, and esophagitis. Trial sample size was chosen to provide 87% power in detecting a 50% median reduction in GERD-HRQL score at an alpha level of 0.05.

NCT ID: NCT00584259 Completed - GERD Clinical Trials

Effect of Coffee on Gastro-Esophageal Disease in Patients With Symptoms of Reflux

Start date: May 2006
Phase: N/A
Study type: Interventional

Investigation evaluating the effect of coffee on gastro-esophageal reflux disease.

NCT ID: NCT00582972 Completed - Osteoporosis Clinical Trials

Does Omeprazole Decrease Intestinal Calcium Absorption?

Start date: January 2008
Phase: Phase 4
Study type: Interventional

The purpose of this study is to measure the effect of omeprazole on intestinal calcium absorption in postmenopausal women.

NCT ID: NCT00575822 Terminated - Clinical trials for Gastroesophageal Reflux Disease (GERD)

A Study to Determine the Effectiveness of Endoscopic Full-Thickness Plication for the Treatment of GERD

Start date: January 2005
Phase: N/A
Study type: Interventional

The aim of this study was to determine the effectiveness of endoscopic full-thickness plication (Plicator; NDO Surgical, Inc., Mansfield, MA) for the treatment of GERD in comparison to a sham procedure. Patients with symptomatic GERD requiring maintenance proton pump inhibitor therapy were entered into a randomized, single-blind, prospective, multicenter trial. Seventy-eight patients were randomly assigned to undergo endoscopic full-thickness restructuring of the gastric cardia with transmural suture. Eighty-one patients underwent a sham procedure. Group assignments were revealed following the 3-month evaluation. The primary endpoint was ≥ 50% improvement in GERD-HRQL score. Secondary endpoints included medication use and esophageal acid exposure. Patients achieving ≥ 50% improvement in GERD-HRQL score at 3-months versus baseline off-meds were considered responsive to their assigned procedure. Patients who failed to reach this level of improvement at 3-months were considered non-responders. Analysis of these dichotomized variables (responder/non-responder) was done using Fisher's exact test comparing the proportion of responders between the active and sham groups. Intent-to-treat analysis was also performed. The null hypothesis was that the proportion of responders was the same in both the active and sham groups. Testing was done at the 5% level of significance (alpha=0.05).

NCT ID: NCT00574925 Completed - Clinical trials for Gastroesophageal Reflux Disease (GERD)

Study to Assess Management Strategies for the Use of Esomeprazole (Nexium) in Helicobacter Pylori Infected Patients

Start date: November 2003
Phase: Phase 4
Study type: Interventional

The primary objective of this study is to investigate whether eradication treatment of Helicobacter pylori followed by therapy with esomeprazole for a total of 8 weeks extends the time to relapse in patients with gastroesophageal reflux disease (GERD). A relapse is defined by two consecutive symptom scores of the Eraflux questionnaire within 14 days that are equal or above the critical value of 25. The secondary objectives are 1. To compare the time to relapse in the two H. pylori positive study groups with the H. pylori negative control group 2. To compare the pattern of inflammation and atrophy in the two H. pylori positive treatment groups with the naturally H. pylori negative control group at relapse. 3. All the above objectives analyzed for the efficacy subset that is the per-protocol patients broken down by effective H. pylori-eradication. Secondary endpoints will be analyzed by the following parameters and their interactions: 1. Treatment : Eradicated, Non-eradicated, Hp-negative control 2. Esophagitis at study start: grades 0, A/B and C/D 3. Gender 4. Alcohol intake 5. NSAID/ASA intake (for histological results) - Trial with medicinal product

NCT ID: NCT00573911 Completed - GERD Clinical Trials

Acid Reflux and Stromal Fibroblasts in Barrett's Esophagus

Start date: August 2007
Phase: Phase 1
Study type: Interventional

Patients with Barrett's Esophagus are known to have excessive distal esophageal acid exposure comparable to patients with erosive esophagitis. A significant proportion of patients with BE who are not symptomatic on treatment continue to have persistent acid reflux. High dose esomeprazole is able to control acid reflux in patients with BE. The effect of acid reflux on Barrett's esophagus stroma is currently unknown. It is our hypothesis that stromal fibroblast activation in Barrett's esophagus is influenced by acid reflux. The specific aim of this proposal will be: To assess the association between acid reflux and subepithelial fibroblasts in Barrett's esophagus.

NCT ID: NCT00567619 Completed - GERD Clinical Trials

LIFE NIS, GERD-Patients - Evaluation of Burden of Disease Determined by GERD Impact Scale (GIS)

Start date: July 2007
Phase: N/A
Study type: Observational

Evaluate burden of disease in Patients with newly occurred upper GI symptoms related to GERD (symptom frequency & severity, QoL, lifestyle modifications, self-medication) - baseline data according to GERD impact scale presenting to specialists, especially internists - Evaluate effect of treatment with a acid suppressive therapy on these parameters: looking for improvement of symptom burden and quality of life according to the GERD impact sca

NCT ID: NCT00545883 Completed - GERD Clinical Trials

Impact of GERD on Daily Life (NIS)

Alegria
Start date: June 2006
Phase: N/A
Study type: Observational

The aim of this study is to gather epidemiological data in a population of GERD patients in primary care with a history of erosive esophagitis (less than or equal to 3 years).

NCT ID: NCT00536328 Terminated - Clinical trials for Gastroesophageal Reflux Disease

What is the Predictive Value of the Reflux Impact Scale

PREDICT
Start date: October 2007
Phase: N/A
Study type: Observational

Gastric distress is a common phenomenon in our society. Heartburn and regurgitation occur daily in about 7% of the adult population,weekly 14-20% pf the adults and monthly in 34-44% of adults. The yearly prevalence of recurrent stomach complaints are frequent reason for consulting a primary care physician and are an important reason for using OTC medication. A good diagnosis is important as functional GERD with possible complications such as strictures and Barrett's esophagus or ulcer disease with life threatening complications such as bleeding & perforations. The clinical diagnosis of reflux disease is mainly based on symptom evaluation. This, however, is hindered by the variety of complaints with different etiology. Treatment with a proton pump inhibitor can be used to confirm the diagnosis reflux disease. A major part of the patients with acid related stomach complaints indeed will experience symptom relief after starting PPI therapy. In this view, it is important to identify these patients who will react on treatment with PPI in quick, accurate, non-invasive and cheap manner. The Reflux Impact Scale (RIS) is validated, short, self explanatory questionnaire which asks for the presence & impact of reflux symptoms. The RIS is developed for PCP to aid in the evaluation & selection of these patient who will profit from treatment with PPI. The aim of this present study is to determine which questions of the RIS can be predictive for reaching treatment success with PPI. Treatment success is determined by asking for patients' satisfaction & completion of the McMaster Overall Treatment Evaluation Heartburn questionnaire.