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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2014-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Eosinophilic Esophagitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Low dose budesonide tablet

Group Type EXPERIMENTAL

low dose budesonide tablet

Intervention Type DRUG

1mg budesonide tablet twice daily AND 5ml placebo suspension twice daily

High dose budesonide tablet

Group Type EXPERIMENTAL

high dose budesonide tablet

Intervention Type DRUG

2mg budesonide tablet twice daily AND 5ml placebo suspension twice daily

High dose budesonide suspension

Group Type EXPERIMENTAL

high dose budesonide suspension

Intervention Type DRUG

placebo tablet twice daily AND 5ml \[0.4mg budesonide/ml\] suspension twice daily

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

placebo tablet twice daily AND 5ml placebo suspension twice daily

Interventions

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low dose budesonide tablet

1mg budesonide tablet twice daily AND 5ml placebo suspension twice daily

Intervention Type DRUG

high dose budesonide tablet

2mg budesonide tablet twice daily AND 5ml placebo suspension twice daily

Intervention Type DRUG

high dose budesonide suspension

placebo tablet twice daily AND 5ml \[0.4mg budesonide/ml\] suspension twice daily

Intervention Type DRUG

Placebo

placebo tablet twice daily AND 5ml placebo suspension twice daily

Intervention Type DRUG

Other Intervention Names

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BET 1mg BID BET 2mg BID BVS 2mg BID

Eligibility Criteria

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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

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No