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

NCT ID: NCT01386112

Last Updated: 2012-11-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2012-10-31

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.

Conditions

Eosinophilic Esophagitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

EUR-1100 1.5 mg

Group Type: EXPERIMENTAL

EUR-1100

Intervention Type: DRUG

Active oral medication

EUR-1100 3.0 mg

Group Type: EXPERIMENTAL

EUR-1100

Intervention Type: DRUG

Active oral medication

placebo

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

matching placebo

Interventions

EUR-1100

Active oral medication

Intervention Type: DRUG

placebo

matching placebo

Intervention Type: DRUG

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Forest Laboratories

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ikuo Hirano, MD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University School of Medicine

Locations

Children's Center for Digestive Health

Atlanta, Georgia, United States

Northwestern University School of Medicine

Chicago, Illinois, United States

Riley Hospital for Children

Indianapolis, Indiana, United States

Mayo Clinic

Rochester, Minnesota, United States

South Jersey Pediatric Gastroenterology

Mays Landing, New Jersey, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

O&O Alpan LLC Center for Clinical Trials

Fairfax, Virginia, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 30476587 (View on PubMed)

Other Identifiers

PR-021

Identifier Type: -

Identifier Source: org_study_id