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| Sponsor: | Children's Hospital Medical Center, Cincinnati |
|---|---|
| Information provided by: | Children's Hospital Medical Center, Cincinnati |
| ClinicalTrials.gov Identifier: | NCT00266578 |
Purpose
The purpose of this study is assessing the efficacy of swallowed Flovent® vs. placebo for the treatment of eosinophilic esophagitis (EE).
| Condition | Intervention | Phase |
|---|---|---|
|
Eosinophilic Esophagitis |
Drug: Fluticasone Propionate |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Effect of Swallowed Fluticasone Propionate on Eosinophilic Esophagitis; A Prospective, Randomized, Placebo-Controlled Trial |
| Enrollment: | 30 |
| Study Start Date: | October 2002 |
| Estimated Study Completion Date: | April 2012 |
| Estimated Primary Completion Date: | April 2012 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 3 Years to 30 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Ohio | |
| Cincinnati Children's Hospital Medical Center | |
| Cincinnati, Ohio, United States, 45229-3039 | |
| Principal Investigator: | Marc E. Rothenberg, M.D., Ph.D. | Children's Hospital Medical Center, Cincinnati |
More Information
| Responsible Party: | Marc Rothenberg, M.D., Ph.D., Children's Hospital Medical Center - Cincinnati |
| ClinicalTrials.gov Identifier: | NCT00266578 History of Changes |
| Other Study ID Numbers: | 02-9-9, FAAN |
| Study First Received: | December 15, 2005 |
| Last Updated: | October 24, 2008 |
| Health Authority: | United States: Institutional Review Board |
|
Eosinophilic Esophagitis |
|
Esophagitis Eosinophilic Esophagitis Eosinophilia Esophageal Diseases Gastrointestinal Diseases Digestive System Diseases Gastroenteritis Leukocyte Disorders Hematologic Diseases Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |
Fluticasone Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Asthmatic Agents Respiratory System Agents Therapeutic Uses Dermatologic Agents Anti-Allergic Agents Anti-Inflammatory Agents |