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| Sponsor: | Swiss EE Study Group |
|---|---|
| Information provided by: | Swiss EE Study Group |
| ClinicalTrials.gov Identifier: | NCT00271349 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Eosinophilic Esophagitis |
Drug: Budesonide |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | Budesonide for Eosinophilic Esophagitis: a Randomized, Placebo-Controlled, Double-Blind Treatment Study |
| Enrollment: | 28 |
| Study Start Date: | December 2005 |
| Study Completion Date: | December 2008 |
| Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
A randomized, double-blind, placebo-controlled, single center clinical trial to evaluate the efficacy and safety of topically applied Budesonide in the treatment of adult patients with Eosinophilic Esophagitis.
Eligibility| Ages Eligible for Study: | 14 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Switzerland, Solothurn | |
| Department of Gastroenterology, Kantonsspital | |
| Olten, Solothurn, Switzerland, 4600 | |
| Study Chair: | Christoph Beglinger, MD | Department of Gastroenterology, University Hospital Basel, Switzerland |
| Study Director: | Hans-Uwe Simon, MD, PhD | Department of Pharmacology, University of Bern, Switzerland |
| Principal Investigator: | Alex Straumann, MD | Department of Gastroenterology, Kantonsspital Olten, Switzerland |
More Information
| Study ID Numbers: | D5257L00017, D5257L00017 |
| Study First Received: | December 29, 2005 |
| Last Updated: | April 20, 2009 |
| ClinicalTrials.gov Identifier: | NCT00271349 History of Changes |
| Health Authority: | Switzerland: Swissmedic |
|
Eosinophilic Esophagitis Budesonide |
|
Anti-Inflammatory Agents Respiratory System Agents Gastrointestinal Diseases Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Budesonide Anti-Asthmatic Agents Hormones Glucocorticoids |
Pharmacologic Actions Esophagitis Digestive System Diseases Autonomic Agents Therapeutic Uses Esophageal Diseases Peripheral Nervous System Agents Gastroenteritis Bronchodilator Agents |