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

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ClinicalTrials.gov Identifier: NCT02280616
Recruitment Status : Completed
First Posted : October 31, 2014
Last Update Posted : January 21, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Eosinophilic Esophagitis Drug: low dose budesonide tablet Drug: high dose budesonide tablet Drug: high dose budesonide suspension Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : June 2011
Actual Primary Completion Date : April 2013
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Budesonide

Arm Intervention/treatment
Experimental: Low dose budesonide tablet Drug: low dose budesonide tablet
1mg budesonide tablet twice daily AND 5ml placebo suspension twice daily
Other Name: BET 1mg BID

Experimental: High dose budesonide tablet Drug: high dose budesonide tablet
2mg budesonide tablet twice daily AND 5ml placebo suspension twice daily
Other Name: BET 2mg BID

Experimental: High dose budesonide suspension Drug: high dose budesonide suspension
placebo tablet twice daily AND 5ml [0.4mg budesonide/ml] suspension twice daily
Other Name: BVS 2mg BID

Placebo Comparator: Placebo Drug: Placebo
placebo tablet twice daily AND 5ml placebo suspension twice daily




Primary Outcome Measures :
  1. Rate of histological remission [ Time Frame: 2 weeks (LOCF) ]
  2. Change in the mean numbers of eos [ Time Frame: 2 weeks (LOCF) ]

Secondary Outcome Measures :
  1. Change in the mean numbers of eos [ Time Frame: 2 weeks (LOCF) ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02280616


Locations
Germany
Center for Digestive Diseases Eppendorf
Hamburg, Germany, 20249
Sponsors and Collaborators
Dr. Falk Pharma GmbH
Investigators
Study Director: Ralph Mueller, PhD Dr. Falk Pharma GmbH

Publications of Results:
Responsible Party: Dr. Falk Pharma GmbH
ClinicalTrials.gov Identifier: NCT02280616     History of Changes
Other Study ID Numbers: BUU-2/EEA
2009-016692-29 ( EudraCT Number )
First Posted: October 31, 2014    Key Record Dates
Last Update Posted: January 21, 2016
Last Verified: January 2016

Additional relevant MeSH terms:
Esophagitis
Eosinophilic Esophagitis
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Eosinophilia
Leukocyte Disorders
Hematologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Budesonide
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists