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

Phase 1

Completed

• Conditions: Eosinophilic Esophagitis
• Interventions: Drug: EUR-1100; Drug: placebo

• Registration Number: NCT01386112
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-06-28
• Study First Submitted QC: 2011-06-29
• Study First Posted: 2011-06-30
• Study Start: 2011-09
• Status Verified: 2012-10
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Last Update Submitted: 2012-10-31
• Last Update Posted: 2012-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EUR-1100 1.5 mg	EUR-1100	-
EUR-1100 3.0 mg	EUR-1100	-
placebo	placebo	-

Primary Outcome Measures

Name	Time	Method
Morning serum cortisol (change from baseline measure)	Screening visit (up to 21 days), week 4, week 8 and follow-up
Standard safety laboratory tests	Screening visit (up to 21 days), week 4, week 8 and follow-up	Hematology, serum chemistry and liver function tests, urinalysis, urine chemistry
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (7)

South Jersey Pediatric Gastroenterology; 🇺🇸 Mays Landing, New Jersey, United States

Northwestern University School of Medicine; 🇺🇸 Chicago, Illinois, United States

Children's Center for Digestive Health; 🇺🇸 Atlanta, Georgia, United States

Riley Hospital for Children; 🇺🇸 Indianapolis, Indiana, United States

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

O&O Alpan LLC Center for Clinical Trials; 🇺🇸 Fairfax, Virginia, United States