A Study in Adolescents and Adults With Eosinophilic Esophagitis (EoE) Measuring Histologic Response and Determine if Reduction in Dysphagia is Achieved
Status: | Completed |
---|---|
Healthy: | No |
Age Range: | 11 - 55 |
Updated: | 2/17/2019 |
Start Date: | October 1, 2015 |
End Date: | January 24, 2019 |
Oral Budesonide Suspension (OBS) in Adolescent and Adult Subjects (11 to 55 Years of Age, Inclusive) With Eosinophilic Esophagitis: A Phase 3 Randomized, Double-blind, Placebo-controlled Study
A study in adolescents and adults with eosinophilic esophagitis (EoE) to measure the
histologic response and determine if any reduction in dysphagia is achieved.
histologic response and determine if any reduction in dysphagia is achieved.
Inclusion Criteria
- Participants is able to provide written informed consent (participant, parent or legal
guardian, and, as appropriate, participant assent) to participate in the study before
completing any study-related procedures.
- Participant is male or female aged 11-55 years, inclusive, at time of consent.
- Participant has histologic evidence of eosinophilic esophagitis (EoE) with a peak
eosinophil count of greater than or equal to (>=) 15/ high-powered field (HPF), from 2
of 3 (proximal, mid-, and/or distal) levels of the esophagus at the screening
endoscopy.
- Participant has a history of clinical symptoms of esophageal dysfunction (for example,
eating problems, abdominal pain, heartburn, dysphagia, vomiting, food impaction,
weight loss) intermittently or continuously at screening (Visit -1).
- Participants must have experienced dysphagia (response of "yes" to question 2 on
Dysphagia Symptom Questionnaire [DSQ]) on a minimum of 4 days and completed the DSQ on
>= 70 percent (%) of days in any 2 consecutive weeks of the screening period and in
the last 2 weeks prior to the baseline visit (Visit 1).
- Participant must not have PPI-responsive EoE based on esophageal biopsies performed
after the patient has been on at least 8 weeks of high-dose PPI therapy (high-dose
therapy refers to the total daily dose, which may have been administered as a once or
twice daily dosing regimen). This may occur at the time of the qualifying
esophagogastroduodenoscopy (EGD) (in which case the same proton pump inhibitor (PPI)
regimen must be continued), or this may have been done previously (in which case PPI
therapy may have been stopped if there was no response to therapy based on esophageal
biopsy results). If PPI responsiveness was excluded by a previous EGD and biopsy, the
historical EGD and biopsy must have been performed after the patient had been on a
minimum of 6 weeks of high-dose PPI therapy.
- Participant will be on a stable (no changes) diet >=3 months prior to the screening
visit (Visit -1).
- Participant is willing and able to continue any dietary therapy, environmental
therapy, and/or medical regimens (including gastric acid suppression) in effect at the
screening visit (Visit -1). There should be no change to these regimens during study
participation.
- All female participants must have a negative serum pregnancy test (beta-human
chorionic gonadotropin [β-hCG]) prior to enrollment into the study. Females of
childbearing potential must agree to continue acceptable birth control measures (for
example, abstinence, stable oral contraceptives, or double-barrier methods) throughout
study participation.
- Participant is willing and has an understanding and ability to fully comply with study
procedures and restrictions defined in this protocol.
Exclusion Criteria
- Participant has any condition or abnormality (including laboratory abnormalities),
current or past, that, in the opinion of the principal investigator or medical
monitor, would compromise the safety of the participant or interfere with or
complicate the assessment of signs or symptoms of EoE. Such conditions may include
psychiatric problems; neurologic deficits or disease; developmental delay;
cardiovascular, metabolic, or pulmonary disease; or previous gastroesophageal surgery.
These should be discussed with the medical monitor.
- Participant has used immunomodulatory therapy within 8 weeks prior to the qualifying
EGD or between the qualifying EGD and baseline visit (Visit 1) or anticipates using
immunomodulatory therapy during the treatment period (except for any ongoing regimen
of allergy shots). Use of long-acting immunomodulatory therapy (for example, Rituxan)
within 3 months of the qualifying EGD should be reviewed with the medical monitor.
- Participant has been using swallowed topical corticosteroid for EoE or systemic
corticosteroid for any condition within the 4 weeks prior to the qualifying EGD,
between the qualifying EGD and baseline visit (Visit 1), or anticipates use during the
treatment period; any temporary use (less than or equal to [<=]7 days) or initiation
of new steroid treatment during the study should be documented and discussed with the
medical monitor prospectively but cannot occur within 4 weeks of the final EGD.
- Participant has been on inhaled steroids and has not been on stable treatment for >=3
months prior to screening visit (Visit -1). Participants on inhaled steroids need to
stay on a stable treatment during study participation. Participant has been on
intranasal steroids and has not been on stable treatment for a minimum of 4 weeks
prior to the qualifying EGD. After the qualifying EGD, participants with seasonal
allergic rhinitis may resume (or discontinue) intranasal corticosteroids based on the
participant's usual treatment regimen for allergy season.
- Participant has initiated, discontinued, or changed dosage regimen of PPIs, H2
antagonists, antacids, or leukotriene inhibitors for any condition (such as
gastroesophageal reflux disease, asthma or allergic rhinitis) within the 4 weeks prior
to the qualifying EGD, between the qualifying EGD and baseline visit (Visit 1), or
anticipates changes in the use of such medications during the treatment period.
- Participant has been using cytochrome P450 3A4 (CYP450 3A4) inhibitors (for example,
ketoconazole, grapefruit juice) within the 2 weeks prior to the baseline visit (Visit
1) or within 5 half-lives (whichever is greater) or anticipates using such medications
during the treatment period.
- Participant has an appearance on qualifying EGD of an esophageal stricture
(high-grade), as defined by the presence of a lesion that does not allow passage of a
diagnostic adult upper endoscope (for example, with an insertion tube diameter of
greater than [>]9 millimeter [mm]).
- Participant is on a pure liquid diet or the 6-food elimination diet.
- Participant has had an esophageal dilation within the 3 months prior to screening
(Visit -1).
- Participant has presence of esophageal varices at the screening endoscopy.
- Participant has any current disease of the gastrointestinal tract, aside from EoE,
including eosinophilic gastritis, enteritis, colitis, or proctitis; inflammatory bowel
disease; or celiac disease.
- Participant has other diseases causing or associated with EoE, including
hypereosinophilic syndrome, collagen vascular disease, vasculitis, achalasia, or
parasitic infection.
- Participant has current evidence of oropharyngeal or esophageal candidiasis.
- Participant has a potentially serious acute or chronic viral infection or
immunodeficiency condition, including tuberculosis, fungal, bacterial, viral/parasite
infection, ocular herpes simplex, herpes esophagitis, or chicken pox/measles.
- Participant has upper gastrointestinal bleeding within 4 weeks prior to the screening
visit (Visit - 1) or between the screening visit and baseline visit (Visit 1).
- Participant has evidence of active infection with Helicobacter pylori.
- Participant has evidence of unstable asthma within 4 weeks prior to the screening
visit (Visit -1) and between the screening visit and baseline visit (Visit 1).
- Participant is female and pregnant or nursing.
- Participant has a history of intolerance, hypersensitivity, or idiosyncratic reaction
to budesonide (or any other corticosteroids) or to any other ingredients of the
investigational product.
- Participant has taken part and received intervention in an interventional study
related to EoE (except for an interventional study for a topical swallowed steroid)
within 6 months prior to the screening visit (Visit -1), or any investigational study
within 30 days prior to the screening visit (Visit -1). An investigational topical
swallowed steroid must have been discontinued at least 30 days prior to the screening
visit (Visit -1).
- Participant has a history or high risk of noncompliance with treatment or regular
clinic visits.
- Participant has previously completed, discontinued, or withdrawn from this study.
- Participant has participated in a previous clinical study involving oral budesonide
suspension (OBS) (SHP621).
- Participant anticipates using sucralfate during the study.
We found this trial at
76
sites
3635 S. Clyde Morris Blvd
Port Orange, Florida 32129
Port Orange, Florida 32129
386-760-3862
Principal Investigator: Donato Ricci, MD
About Us Accord Clinical Research is a privately owned research facility, founded in Port Orange,...
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800 Washington St
Boston, Massachusetts 02111
Boston, Massachusetts 02111
(617) 636-5000
Principal Investigator: John Leung
Phone: 617-636-4941
Tufts Medical Center Tufts Medical Center is an internationally-respected academic medical center – a teaching...
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75 Francis street
Boston, Massachusetts 02115
Boston, Massachusetts 02115
(617) 732-5500
Principal Investigator: Karen Hsu-Blatman
Phone: 617-732-7432
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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Chapel Hill, North Carolina 27599
(919) 962-2211
Principal Investigator: Evan Dellon, MD
Phone: 919-843-7684
University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
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3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
Cincinnati, Ohio 45229
1-513-636-4200
Principal Investigator: Vincent Mukkada, MD
Phone: 513-803-3078
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
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9500 Euclid Avenue
Cleveland, Ohio 44106
Cleveland, Ohio 44106
216.444.2200
Principal Investigator: Scott Gabbard, MD
Phone: 216-444-8562
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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282 Washington St
Hartford, Connecticut 06106
Hartford, Connecticut 06106
(860) 545-9000
Principal Investigator: Wael Sayej
Phone: 860-545-9540
Connecticut Children's Medical Center Connecticut Children’s Medical Center is a nationally recognized, 187-bed not-for-profit children’s...
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1200 Moursund Street
Houston, Texas 77030
Houston, Texas 77030
(713) 798-4951
Principal Investigator: Lubin Arevalo Santana, MD
Phone: 713-798-7616
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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425 University Blvd.
Indianapolis, Indiana 46202
Indianapolis, Indiana 46202
(317) 274-4591
Principal Investigator: John Wo
Phone: 317-948-4272
Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
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4800 Belfort Rd # 2
Jacksonville, Florida 32256
Jacksonville, Florida 32256
Principal Investigator: Vikram Gopal, MD
Phone: 904-383-1177
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610 3rd St # 206
Macon, Georgia 31201
Macon, Georgia 31201
Principal Investigator: Shahriar Sedghi, MD
Phone: 478-464-2600
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Minneapolis, Minnesota 55455
(612) 625-5000
Principal Investigator: Jessica Stumphy
Phone: 612-626-4424
Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
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1211 Medical Center Dr
Nashville, Tennessee 37232
Nashville, Tennessee 37232
(615) 322-5000
Principal Investigator: Michael Vaezi
Phone: 615-322-4643
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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South 34th Street
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19104
215-590-1000
Principal Investigator: Jonathan Spergel
Phone: 215-590-2459
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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3020 Childrens way
San Diego, California 92123
San Diego, California 92123
(858) 576-1700
Principal Investigator: Elizabeth Yu
Phone: 858-966-8152
Rady Children's Hospital - San Diego Rady Children's Hospital-San Diego is the region’s pediatric medical...
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823 SW Mulvane St
Topeka, Kansas 66606
Topeka, Kansas 66606
785-368-0741
Principal Investigator: Curtis Baum, MD
Phone: 785-368-0482
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500 S State St
Ann Arbor, Michigan 48109
Ann Arbor, Michigan 48109
(734) 764-1817
Principal Investigator: Joel Rubenstein, MD
Phone: 734-845-5114
University of Michigan The University of Michigan was founded in 1817 as one of the...
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Asheville, North Carolina 28801
Principal Investigator: Tom Whitlock
Phone: 828-350-3669
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Atlanta, Georgia 30342
Principal Investigator: Benjamin Gold, MD
Phone: 404-503-2279
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Aurora, Colorado 80045
Principal Investigator: Calies Menard-Katcher
Phone: 720-777-2318
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Baton Rouge, Louisiana 70809
Principal Investigator: Satyaprasad Alapati
Phone: 225-231-8783
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Birmingham, Alabama 35294
Principal Investigator: Reed Dimmitt
Phone: 205-975-2758
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300 Longwood Ave
Boston, Massachusetts 02115
Boston, Massachusetts 02115
(617) 355-6000
Principal Investigator: John Lee, MD
Phone: 617-355-4349
Boston Children's Hospital Boston Children's Hospital is a 395-bed comprehensive center for pediatric health care....
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Bozeman, Montana 59718
Principal Investigator: Andrew Gentry, MD
Phone: 406-585-2444
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Bristol, Connecticut 06010
Principal Investigator: Salam Zakko, MD
Phone: 860-585-3838
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Charlotte, North Carolina 28277
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Phone: 980-999-2055
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Chesterfield, Michigan 48098
Principal Investigator: Ronald Fogel, MD
Phone: 586-598-3329
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303 East Superior Street
Chicago, Illinois 60611
Chicago, Illinois 60611
Principal Investigator: Ikuo Hirano
Phone: 312-695-4054
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225 E Chicago Ave
Chicago, Illinois 60611
Chicago, Illinois 60611
(312) 227-4000
Principal Investigator: Amir Kagalwalla
Phone: 312-227-4601
Ann & Robert H. Lurie Children's Hospital of Chicago Ann & Robert H. Lurie Children
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Chula Vista, California 91910
Principal Investigator: Gregory Wiener, MD
Phone: 619-585-8882
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Cincinnati, Ohio 45219
Principal Investigator: Pradeep Bekal
Phone: 513-872-4549
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2600 Clifton Ave
Cincinnati, Ohio 45267
Cincinnati, Ohio 45267
(513) 556-6000
Principal Investigator: Vidhya Kunnathur
Phone: 513-584-2363
University of Cincinnati The University of Cincinnati offers students a balance of educational excellence and...
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Colorado Springs, Colorado 80907
Principal Investigator: Daniel Soteres
Phone: 719-473-8330
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Dayton, Ohio 45440
Principal Investigator: Steven Dellon, MD
Phone: 937-320-5050
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Farmington, Connecticut 06032
Principal Investigator: David Chaletsky, MD
Phone: 860-409-4567
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Fort Sam Houston, Texas 78234
Principal Investigator: Michael Hart
Phone: 210-916-3879
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Great Neck, New York 11023
Principal Investigator: Michael Goldstein, MD
Phone: 516-482-5976
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Greenville, South Carolina 29615
Principal Investigator: Jonathan Markowitz
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Houston, Texas 77079
Principal Investigator: Vikram Jayanty, MD
Phone: 713-932-6446
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Idaho Falls, Idaho 83404
Principal Investigator: Ned Warner, MD
Phone: 208-528-4256
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Inverness, Florida 34452
Principal Investigator: Paul Hellstern, MD
Phone: 352-341-2100
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200 Hawkins Dr,
Iowa City, Iowa 52242
Iowa City, Iowa 52242
866-452-8507
Principal Investigator: Yehudith Assouline-Dayan
Phone: 319-384-9756
University of Iowa Hospitals and Clinics University of Iowa Hospitals and Clinics—recognized as one of...
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Lansdowne Town Center, Virginia 20176
Principal Investigator: Satinder Gill
Phone: 703-723-3670
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Lone Tree, Colorado 80124
Principal Investigator: Theodore Stathos, MD
Phone: 303-790-1515
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Lynchburg, Virginia 24502
Principal Investigator: Larry Clark, MD
Phone: 434-455-8659
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Madison, Wisconsin 53792
(608) 263-2400
Principal Investigator: Sameer Mathur
Phone: 608-265-3556
University of Wisconsin In achievement and prestige, the University of Wisconsin–Madison has long been recognized...
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Marlton, New Jersey 08053
Principal Investigator: Neil Cohen, MD
Phone: 856-552-3618
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Mentor, Ohio 44060
Principal Investigator: Keith Friedenberg, MD
Phone: 440-205-1225
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Metairie, Louisiana 70006
Principal Investigator: David Dulitz, MD
Phone: 504-455-1310
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Mount Airy, North Carolina 27030
Principal Investigator: Glenn Pfitzner
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New Albany, Indiana 47150
Principal Investigator: Steven Harrell
Phone: 812-206-1702
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North Little Rock, Arkansas
Principal Investigator: Donato Ricci
Phone: 501-945-9300
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Ogden, Utah 84405
Principal Investigator: John Lowe, MD
Phone: 801-409-2040
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3366 Northwest Expressway
Oklahoma City, Oklahoma 73112
Oklahoma City, Oklahoma 73112
Principal Investigator: Matthew McBride, MD
Phone: 405-605-0927
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Orlando, Florida 32806
Principal Investigator: Yamen Smadi, MD
Phone: 321-841-1361
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Park Ridge, Illinois 60068
Principal Investigator: Thirumazhisai S. Gunasekaran
Phone: 847-723-5975
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Pasadena, Texas 77504
Principal Investigator: Steven Fein, MD
Phone: 281-487-4257
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530 NE Glen Oak Ave
Peoria, Illinois 61637
Peoria, Illinois 61637
(309) 655-2000
Principal Investigator: Sandeep Gupta
Phone: 309-624-4087
OSF St. Francis Medical Center OSF Saint Francis Medical Center, licensed for 616 beds and...
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1 Illini Drive
Peoria, Illinois 61603
Peoria, Illinois 61603
Principal Investigator: Sandeep Gupta, MD
Phone: 309-624-4087
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3451 Walnut St
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Principal Investigator: Gary Falk, MD
Phone: 215-349-8546
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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1919 E Thomas Rd
Phoenix, Arizona 85006
Phoenix, Arizona 85006
(602) 933-1000
Principal Investigator: Shauna Schroeder
Phone: 602-933-3020
Phoenix Children's Hospital Phoenix Children's Hospital has provided hope, healing, and the best healthcare for...
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Plymouth, Minnesota 55446
Principal Investigator: Benjamin Mitlyng
Phone: 612-870-5560
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Rochester, Minnesota 55905
Principal Investigator: David Katzka, MD
Phone: 507-538-0367
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100 Mario Capecchi Drive
Salt Lake City, Utah 84113
Salt Lake City, Utah 84113
Principal Investigator: Molly O'Gorman
Phone: 801-587-7759
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Shreveport, Louisiana 71103
Principal Investigator: John Provenza
Phone: 318-213-3453
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Southlake, Texas 76092
Principal Investigator: Timothy Ritter
Phone: 469-930-3107
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Tucson, Arizona 85712
Principal Investigator: Sam Moussa, MD
Phone: 520-318-1236
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Tucson, Arizona 85710
Principal Investigator: Gary Gottlieb
Phone: 520-257-3881
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West Monroe, Louisiana 71291
Principal Investigator: Clarence Dunn
Phone: 318-355-3702
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Wheat Ridge, Colorado 80033
Principal Investigator: John Goff, MD
Phone: 303-279-1550
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Wyoming, Michigan 49519
Principal Investigator: Allan Coates, MD
Phone: 616-328-5319
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