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

Eosinophilic Esophagitis Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01386112
• Other study ID #: PR-021
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: June 28, 2011
• Last updated: October 31, 2012
• Start date: September 2011
• Est. completion date: October 2012

Study information

• Verified date: October 2012
• Source: Forest Laboratories
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 55 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Eosinophilic Esophagitis
• Esophagitis

Intervention

Drug:
• EUR-1100
Active oral medication
• placebo
matching placebo

Locations

Country	Name	City	State
United States	Children's Center for Digestive Health	Atlanta	Georgia
United States	Northwestern University School of Medicine	Chicago	Illinois
United States	O&O Alpan LLC Center for Clinical Trials	Fairfax	Virginia
United States	Riley Hospital for Children	Indianapolis	Indiana
United States	South Jersey Pediatric Gastroenterology	Mays Landing	New Jersey
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Forest Laboratories

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Morning serum cortisol (change from baseline measure)		Screening visit (up to 21 days), week 4, week 8 and follow-up	Yes
Primary	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	No
Primary	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)	No
Primary	Physical examination and vital signs collection		Screening (up to 21 days), week4, week 8 and follow-up	No
Secondary	Esophagoduodenoscopy with multiple biopsies		Screening (up to 21 days) and week 8	No
Secondary	Patient reported outcomes, and physician global assessment		Screening (up to 21 days), week 4 and 8.	No