Efficacy and Safety of Vonoprazan Compared to Lansoprazole in the Maintenance Treatment of Erosive...
Erosive EsophagitisThis is a comparative study of vonoprazan (TAK-438) (10 mg or 20 mg) in participants in whom endoscopic healing of erosive esophagitis has been confirmed with vonoprazan or adequate treatment with a proton pump inhibitor (PPI), to demonstrate the non-inferiority of vonoprazan to lansoprazole in their maintenance treatment (6 months or 24 weeks) as well as to determine the clinically recommended dose for vonoprazan for maintenance therapy in erosive esophagitis.
SOFEED: Six Food vs. One Food Eosinophilic Esophagitis Diet Study
Eosinophilic Gastrointestinal Disorders (EGIDs)Eosinophilic Esophagitis (EoE)The purpose of this interventional study is to test and compare the effectiveness of two elimination diets-the 1-food elimination diet (1FED, milk only) and the 6-food elimination diet (6FED, milk, egg, wheat, soy, tree nut/peanuts, and fish/shellfish). The study will also test the effectiveness of swallowed glucocorticoid therapy in some of the study participants for whom diet therapy was not effective.
Anti-Interleukin-5 (IL-5) Study for Hypereosinophilic Syndrome
Hypereosinophilic SyndromesEosinophilic Gastroenteritis2 moreToxicity of anti-IL-5
A Study Comparing Swallowed Flovent and Placebo in Patients With Eosinophilic Disorders
Eosinophilic EsophagitisThe purpose of this study is assessing the efficacy of swallowed Flovent® vs. placebo for the treatment of eosinophilic esophagitis (EE).
A Dose-finding Phase IIb Study With AZD0865 and Esomeprazole in GERD Patients Without Erosive Esophagitis....
GERD Without Erosive EsophagitisThe primary objective is to compare the efficacy between three doses of AZD0865 (25, 50 and 75 mg). The secondary objectives are to compare the efficacy between the three doses of AZD0865 and esomeprazole 20 mg and to evaluate the safety and tolerability of AZD0865.
Budesonide for Eosinophilic Esophagitis
Eosinophilic EsophagitisEosinophilic 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.
A Pilot Study of the Treatment of Eosinophilic Esophagitis With Omalizumab
EsophagitisEosinophilic esophagitis (EE) is an increasingly recognized condition characterized by dysphagia, food impaction or other obstructive esophageal symptoms in children and young adults. The pathophysiology of EE appears to be an allergy/atopy mediated disease. A personal and family history of allergic diseases (food allergies, atopic dermatitis, asthma, allergic rhinitis or conjunctivitis) has been noted in 62-85% of patients with EE. The rising incidence of EE may be related to the worldwide allergy and asthma epidemic. Current treatment of EE is directed at decreasing esophageal allergic inflammation. Oral and topical corticosteroids, cromolyn sodium, montelukast and elemental/elimination diets have all been shown to be effective. However, none of these treatments are directed at the specific pathophysiologic mechanism of EE and some have significant side effects. The shared pathogenetic mechanisms of EE and asthma suggest that therapeutic strategies directed at asthma may also be effective for EE. Specifically those targeted at the allergic immune mechanisms involved with asthma may be effective. Omalizumab is a recently developed anti-IgE antibody that has been shown to decrease the use of inhaled and oral corticosteroids, reduce the frequency of asthma exacerbations, and improve asthma related symptoms in patients with allergic asthma. The objective of the study is to determine the efficacy of omalizumab in the treatment of eosinophilic esophagitis
Study of the Efficiency of Esophageal Dilation on Patient With Eosinophilic Esophagitis
Suspected Eosinophilic EsophagitisThis study is for patients who have had a food impaction and/or difficulty swallowing, who are scheduled to have endoscopy, biopsy and possibly dilatation (stretching) of the esophagus. Standard treatment for people who have food impaction and difficulty swallowing is endoscopy to view the esophagus, tissue biopsies of the lining of the esophagus for diagnosis, and drug therapy including steroids and drugs used to treat reflux disease. Early dilatation or stretching of the esophagus may be done at this time but not always. Some doctors prefer to wait and see if the drugs are affective. It is not known if dilating the esophagus early in treatment adds benefit. Therefore, we are doing this study to compare the two methods of treatment. We will compare two groups: one group will have dilatation performed during the first endoscopy and one group will not have dilatation performed during endoscopy. We will see if dilatation helps prevent food impaction and improves swallowing. Another purpose of this study is to learn more about the causes of swallowing problems, thus extra biopsies will be taken of the esophagus and store them for future research.
Intravenous vs Oral Lansoprazole on Gastric Acid Secretion in Subjects With Erosive Esophagitis...
EsophagitisRefluxThe purpose of this study was to compare the pharmacodynamics of intravenous (IV) lansoprazole to oral lansoprazole capsules, once daily (QD), in participants with erosive esophagitis.
Sensory Evaluation of Dexlansoprazole Delayed-Release Orally Disintegrating Tablets
Gastroesophageal Reflux DiseaseErosive Esophagitis1 moreThe purpose of this study is to measure the in-vivo disintegration time of a single dexlansoprazole delayed-release orally disintegrating (OD) tablet.