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Safety and Tolerability Study of Oral EUR-1100 to Treat Eosinophilic Esophagitis

Primary Purpose

Eosinophilic Esophagitis

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
EUR-1100
placebo
Sponsored by
Forest Laboratories
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Eosinophilic Esophagitis

Eligibility Criteria

12 Years - 55 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

  • 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.

Key Exclusion Criteria:

  • 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.

Sites / Locations

  • Children's Center for Digestive Health
  • Northwestern University School of Medicine
  • Riley Hospital for Children
  • Mayo Clinic
  • South Jersey Pediatric Gastroenterology
  • University of Pennsylvania
  • O&O Alpan LLC Center for Clinical Trials

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

EUR-1100 1.5 mg

EUR-1100 3.0 mg

placebo

Arm Description

Outcomes

Primary Outcome Measures

Morning serum cortisol (change from baseline measure)
Standard safety laboratory tests
Hematology, serum chemistry and liver function tests, urinalysis, urine chemistry
Treatment-emergent adverse events collection
Physical examination and vital signs collection

Secondary Outcome Measures

Esophagoduodenoscopy with multiple biopsies
Patient reported outcomes, and physician global assessment

Full Information

First Posted
June 28, 2011
Last Updated
October 31, 2012
Sponsor
Forest Laboratories
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1. Study Identification

Unique Protocol Identification Number
NCT01386112
Brief Title
Safety and Tolerability Study of Oral EUR-1100 to Treat Eosinophilic Esophagitis
Official Title
A Multicenter, Randomized, Double-blind, Placebo-controlled, Safety and Tolerability Phase 1/2a Study of Two Dosing Regimens of EUR-1100 for Oral Use, in Subjects With Eosinophilic Esophagitis (EoE)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Forest Laboratories

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eosinophilic Esophagitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EUR-1100 1.5 mg
Arm Type
Experimental
Arm Title
EUR-1100 3.0 mg
Arm Type
Experimental
Arm Title
placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
EUR-1100
Intervention Description
Active oral medication
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
matching placebo
Primary Outcome Measure Information:
Title
Morning serum cortisol (change from baseline measure)
Time Frame
Screening visit (up to 21 days), week 4, week 8 and follow-up
Title
Standard safety laboratory tests
Description
Hematology, serum chemistry and liver function tests, urinalysis, urine chemistry
Time Frame
Screening visit (up to 21 days), week 4, week 8 and follow-up
Title
Treatment-emergent adverse events collection
Time Frame
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)
Title
Physical examination and vital signs collection
Time Frame
Screening (up to 21 days), week4, week 8 and follow-up
Secondary Outcome Measure Information:
Title
Esophagoduodenoscopy with multiple biopsies
Time Frame
Screening (up to 21 days) and week 8
Title
Patient reported outcomes, and physician global assessment
Time Frame
Screening (up to 21 days), week 4 and 8.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: 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. Key Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ikuo Hirano, MD
Organizational Affiliation
Northwestern University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Center for Digestive Health
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Northwestern University School of Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611-2951
Country
United States
Facility Name
Riley Hospital for Children
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
South Jersey Pediatric Gastroenterology
City
Mays Landing
State/Province
New Jersey
ZIP/Postal Code
08330
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
O&O Alpan LLC Center for Clinical Trials
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22030
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
30476587
Citation
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.
Results Reference
derived

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Safety and Tolerability Study of Oral EUR-1100 to Treat Eosinophilic Esophagitis

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