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

Primary Purpose

Eosinophilic Esophagitis

Status

Completed

Phase

Phase 2

Locations

Germany

Study Type

Interventional

Intervention

low dose budesonide tablet

high dose budesonide tablet

high dose budesonide suspension

Placebo

About this trial

This is an interventional treatment trial for Eosinophilic Esophagitis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Center for Digestive Diseases Eppendorf

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Arm Label

Low dose budesonide tablet

High dose budesonide tablet

High dose budesonide suspension

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Rate of histological remission

Change in the mean numbers of eos

Secondary Outcome Measures

Change in the mean numbers of eos

Full Information

NCT ID

NCT02280616

First Posted

October 29, 2014

Last Updated

January 20, 2016

Sponsor

Dr. Falk Pharma GmbH

1. Study Identification

Unique Protocol Identification Number

NCT02280616

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

January 2016

Overall Recruitment Status

Completed

Study Start Date

June 2011 (undefined)

Primary Completion Date

April 2013 (Actual)

Study Completion Date

May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Dr. Falk Pharma GmbH

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Eosinophilic Esophagitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

76 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Low dose budesonide tablet

Arm Type

Experimental

Arm Title

High dose budesonide tablet

Arm Type

Experimental

Arm Title

High dose budesonide suspension

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

low dose budesonide tablet

Other Intervention Name(s)

BET 1mg BID

Intervention Description

1mg budesonide tablet twice daily AND 5ml placebo suspension twice daily

Intervention Type

Drug

Intervention Name(s)

high dose budesonide tablet

Other Intervention Name(s)

BET 2mg BID

Intervention Description

2mg budesonide tablet twice daily AND 5ml placebo suspension twice daily

Intervention Type

Drug

Intervention Name(s)

high dose budesonide suspension

Other Intervention Name(s)

BVS 2mg BID

Intervention Description

placebo tablet twice daily AND 5ml [0.4mg budesonide/ml] suspension twice daily

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

placebo tablet twice daily AND 5ml placebo suspension twice daily

Primary Outcome Measure Information:

Title

Rate of histological remission

Time Frame

2 weeks (LOCF)

Title

Change in the mean numbers of eos

Time Frame

2 weeks (LOCF)

Secondary Outcome Measure Information:

Title

Change in the mean numbers of eos

Time Frame

2 weeks (LOCF)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ralph Mueller, PhD

Organizational Affiliation

Dr. Falk Pharma GmbH

Official's Role

Study Director

Facility Information:

Facility Name

Center for Digestive Diseases Eppendorf

City

Hamburg

ZIP/Postal Code

20249

Country

Germany

12. IPD Sharing Statement

Citations:

PubMed Identifier

25792708

Citation

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, Muller M, Krummenerl P, Arts J, Mueller R, Dilger K, Greinwald R, Straumann A. A randomised, double-blind trial comparing budesonide formulations and dosages for short-term treatment of eosinophilic oesophagitis. Gut. 2016 Mar;65(3):390-9. doi: 10.1136/gutjnl-2014-308815. Epub 2015 Mar 19.

Results Reference

result

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

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