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Maintenance of Remission With Budesonide Orodispersible Tablets vs. Placebo in Eosinophilic Esophagitis (EOS-2)

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ClinicalTrials.gov Identifier: NCT02493335
Recruitment Status : Active, not recruiting
First Posted : July 9, 2015
Last Update Posted : January 31, 2020
Sponsor:
Information provided by (Responsible Party):
Dr. Falk Pharma GmbH

Tracking Information
First Submitted Date  ICMJE July 7, 2015
First Posted Date  ICMJE July 9, 2015
Last Update Posted Date January 31, 2020
Actual Study Start Date  ICMJE January 15, 2016
Actual Primary Completion Date November 28, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 7, 2015)
Rate of patients free of treatment failure after 48 weeks of treatment. [ Time Frame: 48 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 7, 2015)
  • Rate of patients with histological relapse [ Time Frame: 48 weeks ]
  • Rate of patients with clinical relapse [ Time Frame: 48 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Maintenance of Remission With Budesonide Orodispersible Tablets vs. Placebo in Eosinophilic Esophagitis
Official Title  ICMJE Double-blind, Randomized, Placebo-controlled, Phase III Study on the Efficacy and Tolerability of a 48-week Treatment With Two Different Doses of Budesonide Effervescent Tablets vs. Placebo for Maintenance of Clinico-pathological Remission in Adult Patients With Eosinophilic Esophagitis
Brief Summary The purpose of this study is to prove the superiority of a 48-weeks treatment with budesonide orodispersible tablets versus placebo for the maintenance of clinico-pathological remission in patients with eosinophilic esophagitis.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Eosinophilic Esophagitis
Intervention  ICMJE
  • Drug: Budesonide 0.5mg orodispersible tablet twice daily
    Other Name: BUL 0.5mg BID
  • Drug: Budesonide 1mg orodispersible tablet twice daily
    Other Name: BUL 1mg BID
  • Drug: Placebo orodispersible tablet twice daily
    Other Name: Placebo BID
Study Arms  ICMJE
  • Experimental: Budesonide 0.5mg orodispersible tablet twice daily
    Budesonide 0.5mg orodispersible tablet twice daily
    Intervention: Drug: Budesonide 0.5mg orodispersible tablet twice daily
  • Experimental: Budesonide 1mg orodispersible tablet twice daily
    Budesonide 1mg orodispersible tablet twice daily
    Intervention: Drug: Budesonide 1mg orodispersible tablet twice daily
  • Placebo Comparator: Placebo orodispersible tablet twice daily
    Placebo orodispersible tablet twice daily
    Intervention: Drug: Placebo orodispersible tablet twice daily
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: July 7, 2015)
204
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Actual Primary Completion Date November 28, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Signed informed consent,
  • Male or female patients, 18 to 75 years of age,
  • Confirmed clinico-pathological diagnosis of eosinophilic esophagitis (EoE) according to established diagnostic criteria
  • Clinico-pathological remission of EoE,
  • A documented trial with proton pump inhibitors (PPIs) in order to rule out PPI-responsive esophageal eosinophilia,
  • Negative pregnancy test in females of childbearing potential at baseline visit.

Exclusion Criteria:

  • Clinical and endoscopic signs of gastroesophageal reflux disease (GERD),
  • History of abnormal results in case of an optionally performed pH-monitoring of the distal esophagus,
  • Patients with PPI-responsive esophageal eosinophilia
  • Achalasia, scleroderma esophagus, or systemic sclerosis,
  • Other clinically 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 [candida esophagitis]),
  • Any relevant systemic disease (e.g., AIDS, active tuberculosis),
  • If careful medical monitoring is not ensured: cardiovascular disease, diabetes mellitus, osteoporosis, active peptic ulcer disease, glaucoma, cataract, or infection,
  • Liver cirrhosis or portal hypertension,
  • History of cancer in the last five years,
  • 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 baseline visit,
  • Existing or intended pregnancy or breast-feeding.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02493335
Other Study ID Numbers  ICMJE BUL-2/EER
2014-001485-99 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Dr. Falk Pharma GmbH
Study Sponsor  ICMJE Dr. Falk Pharma GmbH
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Ralph Mueller, PhD Dr. Falk Pharma GmbH
PRS Account Dr. Falk Pharma GmbH
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP