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| Sponsor: | Children's Hospital Medical Center, Cincinnati |
|---|---|
| Information provided by: | Children's Hospital Medical Center, Cincinnati |
| ClinicalTrials.gov Identifier: | NCT00426283 |
Purpose
The purpose of this study is to test the effects (both good and bad) of swallowed fluticasone propionate (Flovent), in subjects with eosinophilic esophagitis (EE).
| Condition | Intervention | Phase |
|---|---|---|
|
Eosinophilic Esophagitis |
Drug: Flovent Other: Placebo |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Safety/Efficacy Study |
| Official Title: | A Double Blinded, Randomized Trial of Swallowed 1760mcg Fluticasone Propionate Versus Placebo in the Treatment of Eosinophilic Esophagitis |
| Estimated Enrollment: | 40 |
| Study Start Date: | January 2007 |
| Estimated Study Completion Date: | September 2011 |
| Estimated Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Drug
|
Drug: Flovent
1760 mcg daily
|
| 2: Placebo Comparator |
Other: Placebo
1760 mcg daily
|
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| Contact: Bridget K Buckmeier Butz, M.H.S.A | 513-636-5540 | bridget.buckmeier@cchmc.org |
| United States, Colorado | |
| The Children's Hospital of Denver | Not yet recruiting |
| Aurora, Colorado, United States, 80045 | |
| Contact: Elizabeth Esterl, RN, MS, CCRC 720-777-8430 Esterl.Elizabeth@tchden.org | |
| United States, Ohio | |
| Cincinnati Children's Hospital Medical Center | Recruiting |
| Cincinnati, Ohio, United States, 45229 | |
| United States, Pennsylvania | |
| Children's Hospital of Philadelphia | Not yet recruiting |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Contact: Kathy Pinzone, RN, AEC, CCRC 215-590-9959 PINZONE@email.chop.edu | |
| United States, Utah | |
| University of Utah | Not yet recruiting |
| Salt Lake City, Utah, United States, 84132 | |
| Contact: Sarah Burke 801-213-2264 sarah.burke@hsc.utah.edu | |
| Principal Investigator: | Marc E. Rothenberg, M.D., Ph.D. | Children's Hospital Medical Center, Cincinnati |
More Information
| Responsible Party: | Cincinnati Children's Hospital ( Marc E. Rothenberg ) |
| Study ID Numbers: | 06-10-07 |
| Study First Received: | January 22, 2007 |
| Last Updated: | January 22, 2010 |
| ClinicalTrials.gov Identifier: | NCT00426283 History of Changes |
| Health Authority: | United States: Food and Drug Administration; United States: Institutional Review Board |
|
Eosinophilic Esophagitis |
|
Anti-Inflammatory Agents Respiratory System Agents Gastrointestinal Diseases Physiological Effects of Drugs Anti-Asthmatic Agents Anti-Allergic Agents Pharmacologic Actions Esophagitis Digestive System Diseases |
Autonomic Agents Therapeutic Uses Fluticasone Esophageal Diseases Peripheral Nervous System Agents Gastroenteritis Dermatologic Agents Bronchodilator Agents |