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

Eosinophilic Esophagitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02280616
• Other study ID #: BUU-2/EEA
• Secondary ID: 2009-016692-29
• Status: Completed
• Phase: Phase 2
• First received: October 29, 2014
• Last updated: January 20, 2016
• Start date: June 2011
• Est. completion date: May 2014

Study information

• Verified date: January 2016
• Source: Dr. Falk Pharma GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: May 2014
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Major 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

Allocation: Randomized, Endpoint Classification: 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:
• low dose budesonide tablet
1mg budesonide tablet twice daily AND 5ml placebo suspension twice daily
• high dose budesonide tablet
2mg budesonide tablet twice daily AND 5ml placebo suspension twice daily
• high dose budesonide suspension
placebo tablet twice daily AND 5ml [0.4mg budesonide/ml] suspension twice daily
• Placebo
placebo tablet twice daily AND 5ml placebo suspension twice daily

Locations

Country	Name	City	State
Germany	Center for Digestive Diseases Eppendorf	Hamburg

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Falk Pharma GmbH

Country where clinical trial is conducted

Germany, 

References & 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, Müller M, Krummenerl P, Arts J, Mueller R, Dilger K, Greinwald R, Straumann A. A randomised, double — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of histological remission		2 weeks (LOCF)	No
Primary	Change in the mean numbers of eos		2 weeks (LOCF)	No
Secondary	Change in the mean numbers of eos		2 weeks (LOCF)	No