Efficacy, Safety, and Pharmacokinetics of APT-1011 in Subjects With Eosinophilic Esophagitis (EoE)
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Official title
FLUTicasone in Eosinophilic Esophagitis (FLUTE): A Randomized, Double-blind, Placebo-controlled, Dose-ranging, and Maintenance Study of APT-1011 in Subjects With Eosinophilic Esophagitis
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Eosinophilic esophagitis (EoE) is an inflammatory disease of the esophagus, characterized by eosinophilic infiltration and gastrointestinal symptoms. Swallowed, topically acting corticosteroids, such as fluticasone, appear to be effective in resolving acute clinical and pathological features of EoE. APT-1011 is an orally disintegrating tablet (ODT) formulation of fluticasone propionate. This study is designed to compare the efficacy and safety of APT-1011 with placebo in adults with EoE for an initial 12-week treatment period, followed by an additional 40-week maintenance treatment phase. Histologic response, pharmacokinetics, and dysphagia will be assessed.
Study identification
- NCT ID
- NCT03191864
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 106 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 75 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 22, 2017 (Actual)
- Primary completion
- Jan 3, 2019 (Actual)
- Completion
- Oct 23, 2019 (Actual)
- Last update posted
- Apr 26, 2023
2017 – 2019
United States locations
- U.S. sites
- 51
- U.S. states
- 23
- U.S. cities
- 48
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Del Sol Research Management, LLC | Chandler | Arizona | 85224 | — |
| Del Sol Research Management, LLC | Tucson | Arizona | 85710 | — |
| Arkansas Gastroenterology, P.A. | Sherwood | Arkansas | 72120 | — |
| Hope Clinical Research | Canoga Park | California | 91303 | — |
| TriWest Research Associates, LLC | El Cajon | California | 92020-4124 | — |
| SC Clinical Research, Inc. | Garden Grove | California | 92844 | — |
| Beverly Hills Center for Digestive Health | Los Angeles | California | 90048 | — |
| Focilmed | Oxnard | California | 93030 | — |
| Precision Research Institute, LLC | San Diego | California | 92114 | — |
| Medical Associates Research Group, Inc. | San Diego | California | 92123 | — |
| Care Access Research LLC | San Pablo | California | 94806 | — |
| Stanford University School of Medicine | Stanford | California | 94305-2200 | — |
| St. Jude Healthcare | Yorba Linda | California | 92886 | — |
| Western Connecticut Health Network | Danbury | Connecticut | 06810 | — |
| Medical Research Center of Connecticut, LLC | Hamden | Connecticut | 06518 | — |
| Eastern Research, Inc. | Hialeah | Florida | 33013 | — |
| Nature Coast Clinical Research, LLC | Inverness | Florida | 34452 | — |
| Sunrise Medical Research | Lauderdale Lakes | Florida | 33319 | — |
| DBC Research, Corp | Pembroke Pines | Florida | 33029 | — |
| Northwestern Medical Faculty Foundation | Chicago | Illinois | 60611 | — |
| Southwest Gastroenterology | Oak Lawn | Illinois | 60453-3767 | — |
| Rockford Gastroenterology Associates, Ltd. | Rockford | Illinois | 61107 | — |
| MediSphere Medical Research Center, an AMR affiliate | Evansville | Indiana | 47714 | — |
| Cotton-O'Neil Clinical Research Center, Digestive Health | Topeka | Kansas | 66606 | — |
| Gastroenterology Associates | Hazard | Kentucky | 41701 | — |
| Clinical Trials of America, Inc. | West Monroe | Louisiana | 71291 | — |
| Henry Ford Medical Center | Novi | Michigan | 48377-3600 | — |
| Metro Health | Wyoming | Michigan | 49519 | — |
| St. Louis Center for Clinical Research | St Louis | Missouri | 63128 | — |
| Long Island Gastrointestinal Research Group, LLP | Great Neck | New York | 11023 | — |
| Weill Cornell Medical College | New York | New York | 10021 | — |
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27514 | — |
| Research Institute of the Carolinas, PLC | Mooresville | North Carolina | 28117 | — |
| Carolina's GI Research, LLC | Raleigh | North Carolina | 27607 | — |
| Wake Research Associates, LLC | Raleigh | North Carolina | 27612 | — |
| PMG Research of Salisbury, LLC | Salisbury | North Carolina | 28144 | — |
| Bernstein Clinical Research Center, LLC | Cincinnati | Ohio | 45231 | — |
| Aventiv Research Inc. | Columbus | Ohio | 43231 | — |
| Unity Clinical Research | Oklahoma City | Oklahoma | 73118 | — |
| Allergy and Asthma Center of South Oregon | Medford | Oregon | 97504 | — |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | — |
| Digestive Disease Associates, Ltd. | Wyomissing | Pennsylvania | 19610 | — |
| Rapid City Medical Center, LLP | Rapid City | South Dakota | 57701 | — |
| Advanced Gastroenterology | Union City | Tennessee | 38261 | — |
| Avant Research Associates, LLC - Austin | Austin | Texas | 78704 | — |
| Avant Research Associates, LLC | Beaumont | Texas | 77702 | — |
| DHAT Research Institute | Richardson | Texas | 75082 | — |
| Advanced Research Institute | Ogden | Utah | 84405 | — |
| University of Utah | Salt Lake City | Utah | 84108 | — |
| Care Access Research LLC | Salt Lake City | Utah | 84124 | — |
| Verity Research Inc | Fairfax | Virginia | 22031 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 24 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03191864, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 26, 2023 · Synced Nov 15, 2026
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