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Esophagitis clinical trials

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NCT ID: NCT00426283 Completed - Clinical trials for Eosinophilic Esophagitis

A Study of Flovent in Patients With Eosinophilic Esophagitis

Start date: January 2007
Phase: Phase 2
Study type: Interventional

The purpose of this study is to test the effects (both good and bad) of high dose swallowed fluticasone propionate (Flovent) in subjects with eosinophilic esophagitis (EoE).

NCT ID: NCT00358449 Completed - Clinical trials for Oesophagitis, Eosinophilic

Intravenous Mepolizumab In Children With Eosinophilic Esophagitis

Start date: September 11, 2006
Phase: Phase 2
Study type: Interventional

This study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of intravenous mepolizumab in pediatric subjects with eosinophilic esophagitis.

NCT ID: NCT00321737 Completed - Esophagitis, Reflux Clinical Trials

Efficacy and Safety of Dexlansoprazole MR Compared to Placebo on Maintaining Healing in Subjects With Healed Erosive Esophagitis

Start date: May 2006
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the ability of once-daily (QD) treatment with dexlansoprazole modified release (MR) 30 mg and 60 mg or placebo in maintaining healing of erosive esophagitis (EE).

NCT ID: NCT00284908 Completed - Clinical trials for Gastroesophageal Reflux

Dose-Effect of S-Tenatoprazole-Na(STU-Na) 30 mg, 60 mg, 90 mg and 120 mg in Healthy Volunteers

Start date: September 2006
Phase: Phase 1
Study type: Interventional

S-Tenatoprazole-Na (STU-Na), a new drug currently under clinical development, belongs to a class of drugs, called proton pump inhibitors (PPls). Some PPIs are already commercially available. STU-Na will be used for treatment of acid related diseases (gastroduodenal ulcers, erosive or ulcerative esophagitis due to gastroesophageal reflux disease). This study evaluates the degree of acid suppression by different doses of STU-Na. The degree of acid suppression is considered to be correlated with clinical efficacy. In this study four dosages of STU-Na (30 mg, 60 mg, 90 mg, and 120 mg) will be tested in each volunteer. First, one of the dosages will be orally administered for five days. Then, a nine to sixteen day period without study drug administration will follow prior to the administration of the next dosage, for again five days. Each volunteer will have a total of four study drug administration periods. After the last study drug intake in period 1, 2 and 3 pharmacokinetic blood sampling will be done for four days. After the last study drug intake in period 4 pharmacokinetic blood sampling will be done for five days. Pharmacokinetic blood sampling consists of several blood draws over a pre-determined time period. The pharmacokinetic blood sampling measures the medication concentration in the blood at pre-defined time points. After the last study drug intake in period 1, 2, 3, and 4, gastric acidity will be measured for 24 hours by means of a thin tube that will be inserted into the stomach through the nostril to evaluate the efficacy of the different dosages of STU-Na.

NCT ID: NCT00275561 Completed - Clinical trials for Eosinophilic Esophagitis

Topical Steroid Treatment for Eosinophilic Esophagitis

Start date: November 2005
Phase: Phase 2
Study type: Interventional

This was a randomized controlled trial of swallowed fluticasone vs. placebo for eosinophilic esophagitis. Eosinophilic esophagitis is an inflammatory condition in which the wall of the esophagus becomes filled with large numbers of eosinophils, a type of white blood cell. Patients who have this condition have difficulty in swallowing (dysphagia) solid food. Prior to treatment the patients had biopsies of their esophagus and took questionnaires regarding their symptoms. Treatment was given for 6 weeks, after which biopsies were taken from the esophagus to measure any changes in the tissue from before treatment. The primary endpoint was improvement in dysphagia as measured by the validated Mayo Dysphagia Questionaire. Secondary outcomes included partial symptom response, and histologic (tissue) response to treatment.

NCT ID: NCT00274703 Completed - Clinical trials for Oesophagitis, Eosinophilic

An Evaluation Of Mepolizumab In Therapy Of Eosinophilic Oesophagitis In Adult Patients

Start date: December 2005
Phase: Phase 2
Study type: Interventional

Eosinophils play a key role in the pathogenesis of eosinophilic oesophagitis. Therapies that suppress eosinophil recruitment and activation may give a benefit. Mepolizumab is a humanised monoclonal antibody against interleukin-5 (IL-5). This study will evaluate the ability of mepolizumab to decrease the recruitment and infiltration of eosinophils into the oesophagus, thereby reducing the inflammation and symptoms of EE (eosinophilic oesophagitis) in adult patients.

NCT ID: NCT00272818 Completed - Colitis Clinical Trials

Study to Identify Non-Invasive Markers of Gastrointestinal Allergy

Start date: September 2004
Phase:
Study type: Observational

The incidence of gastrointestinal allergy is on the rise and can be manifest in a number of different clinical presentations. The goal of this study is to evaluate the measurement of CD23, a protein that can be identified stool, urine, and blood, as a non-invasive marker for use in the diagnosis and interval assessment of patients with known or suspected gastrointerstianl allergy. Eosinophilic esophagitis (EE) is a disorder typically found in school-age and adolescent children, and is more prevalent in male patients. Patients with EE typically present with symptoms of heartburn or difficulties swallowing. Blood and x-ray studies may be normal or display non-specific findings. The diagnosis of EE rests on a combination of clinical symptoms, and the results of endoscopic and histologic studies. There is currently no biochemical marker that can be used to monitor disease course in these patients. Cow milk protein intolerance (CMPI) is an allergic process affecting the distal gastrointestinal tract in infants. As such, it often presents as diarrhea without or without the presence of gross rectal bleeding in infants ranging in age from birth to 6 months of age. Children display symptoms of abdominal disress including emesis, cramping, colic, or feeding difficulties. The diagnosis is based on an appropriate clinical history and supporting physical exam (typically normal). Treatment involves removal of the offending dietary antigens which include cow or soy milk protein Eosinophilic crypt abscesses, or collections of eosinophils within the intestine can also be seen. CD23 is a protein that can be found on allergy-type white blood cells (eosinophils), as well as on the cells that line the gastrointestinal tract. Previous studies have reported increased levels of CD23 in infants with cow's milk allergy. CD23 is also elevated in infants and children with allergic disease. Levels of CD23 appears to fall in conjunction with therapy.

NCT ID: NCT00271349 Completed - Clinical trials for Eosinophilic Esophagitis

Budesonide for Eosinophilic Esophagitis

BEE
Start date: December 2005
Phase: Phase 2
Study type: Interventional

Eosinophilic Esophagitis (EE) is a chronic, T-helper 2 cell (TH2) - type inflammatory disorder of the esophagus with a rapidly increasing prevalence. Studies analyzing the natural course of EE provide strong evidence, that the chronic inflammation leads to irreversible structural changes in the esophagus with a loss of the mucosal elasticity and a fibrosis of the sub-epithelial esophageal layers with a concomitant risk of impairment in function. Treatment strategies in chronic inflammations have, in general, two main goals: 1) Relief of symptoms and 2) Prevention of long-term damage of the affected organ. Until now, the treatment of EE is still controversial. Standard recommendations for therapy of this chronic eosinophilic inflammation include dilation, systemic or topical corticosteroids and leukotriene antagonists. Several of these reports demonstrate, that topical corticosteroids may be effective for symptom control as well as for down-regulating the local inflammation. Furthermore it has been demonstrated, that treatment with topical corticosteroids is as effective as oral prednisone. However, the majority of therapeutic recommendations are based on clinical observations, case reports or small case series. The purpose of this study is the evaluation of the efficacy and the safety of a monotherapy with a topical corticosteroid as short-term induction-treatment and as long-term, maintenance-treatment compared with placebo, in the treatment of adult patients with active EE.

NCT ID: NCT00267475 Completed - Clinical trials for Eosinophilic Esophagitis

Data Bank for Eosinophilic Disorders

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

The purpose of this study is to conduct a translational study in patients with primary eosinophil associated gastrointestinal disorders [EGID] (e.g. eosinophilic esophagitis eosinophilic gastritis, eosinophilic enteritis [EE], eosinophilic colitis, and eosinophilic gastroenteritis [EGE]) with the aim of developing a data bank containing pertinent patient demographic information, tissue samples, and DNA, which will facilitate research on the pathophysiology of inflammatory disorders and the development of a verified successful clinical treatment program.

NCT ID: NCT00266578 Completed - Clinical trials for Eosinophilic Esophagitis

A Study Comparing Swallowed Flovent and Placebo in Patients With Eosinophilic Disorders

Start date: October 2002
Phase: Phase 3
Study type: Interventional

The purpose of this study is assessing the efficacy of swallowed Flovent® vs. placebo for the treatment of eosinophilic esophagitis (EE).