Budesonide Orodispersible Tablet vs. Placebo in Active Eosinophilic Esophagitis

Eosinophilic Esophagitis Clinical Trial

— EOS-1  

Official title:

Double-blind, Randomized, Placebo-controlled, Phase III Trial on the Efficacy and Tolerability of a 6-week Treatment With Budesonide Effervescent Tablets vs. Placebo for Induction of Clinico-pathological Remission in Adult Patients With Active Eosinophilic Esophagitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02434029
• Other study ID #: BUL-1/EEA
• Secondary ID: 2014-001484-12
• Status: Completed
• Phase: Phase 3
• First received: April 30, 2015
• Last updated: February 2, 2017
• Start date: November 11, 2015
• Est. completion date: October 4, 2016

Study information

• Verified date: February 2017
• Source: Dr. Falk Pharma GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to prove the superiority of a 6-weeks treatment with budesonide effervescent tablets versus placebo for the induction of clinico-pathological remission in patients with acute eosinophilic esophagitis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: October 4, 2016
• Est. primary completion date: August 4, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

• Active symptomatic and histological 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 screening visit,

• Existing or intended pregnancy or breast-feeding.

Related Conditions & MeSH terms

• Eosinophilic Esophagitis
• Esophagitis

Intervention

Drug:
• Budesonide 1mg orodispersible tablet twice daily

• Placebo orodispersible tablet 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, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of clinico-pathological remission		6 weeks
Secondary	Rate of patients with histological remission		6 weeks
Secondary	Rate of patients with resolutions of symptoms measured by numerical rating score of symptoms		week 6