Budesonide Effervescent Tablets vs. Viscous Budesonide Suspension vs. Placebo in Eosinophilic Esophagitis

Phase 2

Completed

• Conditions: Eosinophilic Esophagitis
• Interventions: Drug: low dose budesonide tablet; Drug: high dose budesonide suspension; Drug: Placebo; Drug: high dose budesonide tablet

• Registration Number: NCT02280616
• Lead Sponsor: Dr. Falk Pharma GmbH

Brief Summary

The purpose of this study is to assess the efficacy of a low and high dose of a budesonide effervescent tablet and oral viscous budesonide suspension vs. placebo for the induction treatment of active eosinophilic esophagitis.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06
• Primary Completion: 2013-04
• Study Completion: 2014-05
• Study First Submitted: 2014-10-29
• Study First Submitted QC: 2014-10-30
• Study First Posted: 2014-10-31
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-20
• Last Update Posted: 2016-01-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

Inclusion Criteria

• Signed informed consent
• Male or female patients, 18 to 75 years of age
• Confirmed clinicopathological diagnosis of EoE according to established diagnostic criteria:

(A) Clinical symptoms of esophageal dysfunction (B) Peak eosinophils ≥ 15 in at least 1 high-power field (hpf)

• Active symptomatic and histological EoE at baseline

Major

Exclusion Criteria

• Clinically and endoscopically suspicion for gastroesophageal reflux disease, achalasia, or sklerodermia
• Gastroesophageal reflux disease and PPI-responsive esophageal eosinophilia
• Other clinical evident causes than EoE for esophageal eosinophilia
• Any concomitant esophageal disease and relevant gastro-intestinal disease (celiac disease, inflammatory bowel disease, oropharyngeal or esophageal bacterial, viral, or fungal infection)
• Any relevant systemic disease (e.g., AIDS, active tuberculosis)
• Abnormal hepatic function at screening visit, liver cirrhosis, or portal hypertension
• Abnormal renal function at screening
• History of cancer in the last five years (except for non-metastatic cancers, e.g., basalioma)
• History of esophageal surgery at any time or of esophageal dilation procedures within the last 8 weeks prior to screening visit
• Upper gastrointestinal bleeding within 8 weeks prior to screening visit
• Concomitant, or within the 4 weeks prior to screening visit, treatment with systemic therapies for any reason that may affect assessment of primary and secondary endpoints, i.e., systemic glucocorticoids, histamine antagonists, mast cell stabilizers, leukotriene receptor antagonists, biologics, or immunosuppressants
• Concomitant, or within the 2 weeks prior to screening visit, treatment with topical therapies for any reason that may affect assessment of primary and secondary endpoints, i.e., topical glucocorticoids or inhaled sodium cromoglycate
• Installation of dietary restrictions within 4 weeks prior to screening visit or during treatment
• Intake of grapefruit containing food or beverages during the treatment with study medication
• Known intolerance/hypersensitivity to study drug
• Existing or intended pregnancy or breast-feeding

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low dose budesonide tablet	low dose budesonide tablet	-
High dose budesonide suspension	high dose budesonide suspension	-
Placebo	Placebo	-
High dose budesonide tablet	high dose budesonide tablet	-

Primary Outcome Measures

Name	Time	Method
Rate of histological remission	2 weeks (LOCF)
Change in the mean numbers of eos	2 weeks (LOCF)

Secondary Outcome Measures

Name	Time	Method
Change in the mean numbers of eos	2 weeks (LOCF)

Trial Locations

Locations (1)

Center for Digestive Diseases Eppendorf; 🇩🇪 Hamburg, Germany