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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

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.

Condition or disease Intervention/treatment Phase
Eosinophilic Esophagitis Drug: Budesonide 0.5mg orodispersible tablet twice daily Drug: Budesonide 1mg orodispersible tablet twice daily Drug: Placebo orodispersible tablet twice daily Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 204 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : January 15, 2016
Actual Primary Completion Date : November 28, 2018
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Budesonide

Arm Intervention/treatment
Experimental: Budesonide 0.5mg orodispersible tablet twice daily
Budesonide 0.5mg orodispersible tablet twice daily
Drug: Budesonide 0.5mg orodispersible tablet twice daily
Other Name: BUL 0.5mg BID

Experimental: Budesonide 1mg orodispersible tablet twice daily
Budesonide 1mg orodispersible tablet twice daily
Drug: Budesonide 1mg orodispersible tablet twice daily
Other Name: BUL 1mg BID

Placebo Comparator: Placebo orodispersible tablet twice daily
Placebo orodispersible tablet twice daily
Drug: Placebo orodispersible tablet twice daily
Other Name: Placebo BID




Primary Outcome Measures :
  1. Rate of patients free of treatment failure after 48 weeks of treatment. [ Time Frame: 48 weeks ]

Secondary Outcome Measures :
  1. Rate of patients with histological relapse [ Time Frame: 48 weeks ]
  2. Rate of patients with clinical relapse [ Time Frame: 48 weeks ]


Information from the National Library of Medicine

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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

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.

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): NCT02493335


Locations
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Germany
Center for Digestive Diseases Eppendorf
Hamburg, Germany, 20249
Sponsors and Collaborators
Dr. Falk Pharma GmbH
Investigators
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Study Director: Ralph Mueller, PhD Dr. Falk Pharma GmbH
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Responsible Party: Dr. Falk Pharma GmbH
ClinicalTrials.gov Identifier: NCT02493335    
Other Study ID Numbers: BUL-2/EER
2014-001485-99 ( EudraCT Number )
First Posted: July 9, 2015    Key Record Dates
Last Update Posted: January 31, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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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