Budesonide Effervescent Tablets vs. Viscous Budesonide Suspension vs. Placebo in Eosinophilic Esophagitis
Double-blind, Double-dummy, Randomized, Placebo-controlled, Phase IIa Study on the Efficacy and Tolerability of a 14-day Treatment With Budesonide Effervescent Tablets vs. Viscous Budesonide Suspension vs. Placebo in Patients With Eosinophilic Esophagitis
2 other identifiers
interventional
76
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jun 2011
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2014
CompletedFirst Submitted
Initial submission to the registry
October 29, 2014
CompletedFirst Posted
Study publicly available on registry
October 31, 2014
CompletedJanuary 21, 2016
January 1, 2016
1.8 years
October 29, 2014
January 20, 2016
Conditions
Outcome Measures
Primary Outcomes (2)
Rate of histological remission
2 weeks (LOCF)
Change in the mean numbers of eos
2 weeks (LOCF)
Secondary Outcomes (1)
Change in the mean numbers of eos
2 weeks (LOCF)
Study Arms (4)
Low dose budesonide tablet
EXPERIMENTALHigh dose budesonide tablet
EXPERIMENTALHigh dose budesonide suspension
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
1mg budesonide tablet twice daily AND 5ml placebo suspension twice daily
2mg budesonide tablet twice daily AND 5ml placebo suspension twice daily
placebo tablet twice daily AND 5ml \[0.4mg budesonide/ml\] suspension twice daily
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Center for Digestive Diseases Eppendorf
Hamburg, 20249, Germany
Related Publications (1)
Miehlke S, Hruz P, Vieth M, Bussmann C, von Arnim U, Bajbouj M, Schlag C, Madisch A, Fibbe C, Wittenburg H, Allescher HD, Reinshagen M, Schubert S, Tack J, Muller M, Krummenerl P, Arts J, Mueller R, Dilger K, Greinwald R, Straumann A. A randomised, double-blind trial comparing budesonide formulations and dosages for short-term treatment of eosinophilic oesophagitis. Gut. 2016 Mar;65(3):390-9. doi: 10.1136/gutjnl-2014-308815. Epub 2015 Mar 19.
PMID: 25792708RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ralph Mueller, PhD
Dr. Falk Pharma GmbH
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 29, 2014
First Posted
October 31, 2014
Study Start
June 1, 2011
Primary Completion
April 1, 2013
Study Completion
May 1, 2014
Last Updated
January 21, 2016
Record last verified: 2016-01