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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01386112
Recruitment Status : Completed
First Posted : June 30, 2011
Last Update Posted : November 2, 2012
Information provided by (Responsible Party):
Forest Laboratories

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.

Condition or disease Intervention/treatment Phase
Eosinophilic Esophagitis Drug: EUR-1100 Drug: placebo Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : September 2011
Actual Primary Completion Date : October 2012
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: EUR-1100 1.5 mg Drug: EUR-1100
Active oral medication

Experimental: EUR-1100 3.0 mg Drug: EUR-1100
Active oral medication

Placebo Comparator: placebo Drug: placebo
matching placebo

Primary Outcome Measures :
  1. Morning serum cortisol (change from baseline measure) [ Time Frame: Screening visit (up to 21 days), week 4, week 8 and follow-up ]
  2. Standard safety laboratory tests [ Time Frame: Screening visit (up to 21 days), week 4, week 8 and follow-up ]
    Hematology, serum chemistry and liver function tests, urinalysis, urine chemistry

  3. 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) ]
  4. Physical examination and vital signs collection [ Time Frame: Screening (up to 21 days), week4, week 8 and follow-up ]

Secondary Outcome Measures :
  1. Esophagoduodenoscopy with multiple biopsies [ Time Frame: Screening (up to 21 days) and week 8 ]
  2. Patient reported outcomes, and physician global assessment [ Time Frame: Screening (up to 21 days), week 4 and 8. ]

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 55 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01386112

United States, Georgia
Children's Center for Digestive Health
Atlanta, Georgia, United States, 30342
United States, Illinois
Northwestern University School of Medicine
Chicago, Illinois, United States, 60611-2951
United States, Indiana
Riley Hospital for Children
Indianapolis, Indiana, United States, 46202
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, New Jersey
South Jersey Pediatric Gastroenterology
Mays Landing, New Jersey, United States, 08330
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Virginia
O&O Alpan LLC Center for Clinical Trials
Fairfax, Virginia, United States, 22030
Sponsors and Collaborators
Forest Laboratories
Principal Investigator: Ikuo Hirano, MD Northwestern University School of Medicine

Responsible Party: Forest Laboratories Identifier: NCT01386112     History of Changes
Other Study ID Numbers: PR-021
First Posted: June 30, 2011    Key Record Dates
Last Update Posted: November 2, 2012
Last Verified: October 2012

Additional relevant MeSH terms:
Eosinophilic Esophagitis
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Leukocyte Disorders
Hematologic Diseases
Hypersensitivity, Immediate
Immune System Diseases