NCT01386112

Brief Summary

Eosinophilic esophagitis (EoE) is an inflammatory disease of the esophagus, characterized by eosinophilic infiltration and gastrointestinal (GI) symptoms. There are no pharmacological treatments for EoE approved by the US Food and Drug Administration (FDA). Supported by published case series and controlled trials in children and adults, the most widely used drug treatment for EoE is off-label use of corticosteroids intended for local (esophageal mucosal) action. This study will evaluate the safety and tolerability of orally administered EUR-1100 once or twice daily. Eligible subjects will be randomized into one of the 3 treatment groups. The Treatment Period will be 8 weeks during which subjects will visit the clinic at the screening visit, randomization, week 4, 8 and 1 week after end of treatment for clinical symptom assessment and safety evaluation. Additional phone visits will occur at week 2 and week 6.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Sep 2011

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 28, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 30, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2011

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

November 2, 2012

Status Verified

October 1, 2012

Enrollment Period

1.1 years

First QC Date

June 28, 2011

Last Update Submit

October 31, 2012

Conditions

Eosinophilic Esophagitis

Outcome Measures

Primary Outcomes (4)

  • Morning serum cortisol (change from baseline measure)

    Screening visit (up to 21 days), week 4, week 8 and follow-up

  • Standard safety laboratory tests

    Hematology, serum chemistry and liver function tests, urinalysis, urine chemistry

    Screening visit (up to 21 days), week 4, week 8 and follow-up

  • Treatment-emergent adverse events collection

    Screening visit (up to 21 days), Randomization day, week 2 and week 6(phone visit), week 4 and week 8 (office visit), follow-up (office visit, up to 11 days after week 8 visit)

  • Physical examination and vital signs collection

    Screening (up to 21 days), week4, week 8 and follow-up

Secondary Outcomes (2)

  • Esophagoduodenoscopy with multiple biopsies

    Screening (up to 21 days) and week 8

  • Patient reported outcomes, and physician global assessment

    Screening (up to 21 days), week 4 and 8.

Study Arms (3)

EUR-1100 1.5 mg

EXPERIMENTAL
Drug: EUR-1100

EUR-1100 3.0 mg

EXPERIMENTAL
Drug: EUR-1100

placebo

PLACEBO COMPARATOR
Drug: placebo

Interventions

EUR-1100DRUG

Active oral medication

EUR-1100 1.5 mgEUR-1100 3.0 mg
placeboDRUG

matching placebo

placebo

Eligibility Criteria

Age12 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Male and female subjects aged ≥ 12 and ≤ 55 years;
  • Written informed consent (parent or guardian must sign when applicable) and assent form, if required;
  • Evidence of eosinophilic esophagitis defined by esophageal mucosal eosinophil count greater than or equal to 24 per HPF (400x magnification) in at least 1 of the esophageal sites biopsied (proximal/middle and/or distal);
  • Lack of histological response to previously administered high dose proton pump inhibitor;
  • Clinical symptoms of eosinophilic esophagitis with at least one of the following symptoms: chest pain or discomfort, dysphagia (difficulty swallowing) or food impaction.

You may not qualify if:

  • Known contraindication, hypersensitivity or intolerance to corticosteroids;
  • Any physical, mental, or social condition, history of illness or laboratory abnormality that, in the investigator's judgment, might interfere with study procedures or the ability of the subject to adhere to and complete the study;
  • Oral or esophageal mucosal infection of any type;
  • Any condition affecting the esophageal mucosa or altering esophageal motility other than EoE;
  • Use of systemic (oral or parenteral) or inhaled, intranasal or high-potency dermal topical corticosteroids in the 30 days prior to the esophageal biopsy required for entrance to this study (or prior to EGD if done during the pre-Screening period) or at any time between the biopsy and the Randomization Visit;
  • Adrenal suppression;
  • Any medical condition in which the use of anti-inflammatory or immunosuppressant drugs are required or may be anticipated to be required during the study;
  • Contraindication to EGD or esophageal biopsy or narrowing of the esophagus precluding EGD;
  • History of esophageal or gastric surgery (history of esophageal dilatation is allowed);
  • Gastrointestinal bleeding;
  • Current chronic infection, immunosuppression, immunodeficiency;
  • History or presence of Crohn's disease, celiac disease, or other inflammatory disease of the gastrointestinal tract;
  • Alcohol or drug abuse;
  • Female subjects who are pregnant or breastfeeding;
  • Participation in a clinical study involving an investigational drug within 30 days of the Screening Visit.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Children's Center for Digestive Health

Atlanta, Georgia, 30342, United States

Location

Northwestern University School of Medicine

Chicago, Illinois, 60611-2951, United States

Location

Riley Hospital for Children

Indianapolis, Indiana, 46202, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

South Jersey Pediatric Gastroenterology

Mays Landing, New Jersey, 08330, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

O&O Alpan LLC Center for Clinical Trials

Fairfax, Virginia, 22030, United States

Location

Related Publications (1)

  • Schoepfer AM, Hirano I, Coslovsky M, Roumet MC, Zwahlen M, Kuehni CE, Hafner D, Alexander JA, Dellon ES, Gonsalves N, Leung J, Bussmann C, Collins MH, Newbury RO, Smyrk TC, Woosley JT, Yang GY, Romero Y, Katzka DA, Furuta GT, Gupta SK, Aceves SS, Chehade M, Spergel JM, Falk GW, Meltzer BA, Comer GM, Straumann A, Safroneeva E; International EEsAI Study Group. Variation in Endoscopic Activity Assessment and Endoscopy Score Validation in Adults With Eosinophilic Esophagitis. Clin Gastroenterol Hepatol. 2019 Jul;17(8):1477-1488.e10. doi: 10.1016/j.cgh.2018.11.032. Epub 2018 Nov 23.

    PMID: 30476587DERIVED

MeSH Terms

Conditions

Eosinophilic Esophagitis

Condition Hierarchy (Ancestors)

EsophagitisEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesGastroenteritisEosinophiliaLeukocyte DisordersHematologic DiseasesHemic and Lymphatic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Ikuo Hirano, MD

    Northwestern University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 28, 2011

First Posted

June 30, 2011

Study Start

September 1, 2011

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

November 2, 2012

Record last verified: 2012-10

Locations

US(7)