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Budesonide Orodispersible Tablet vs. Placebo in Active Eosinophilic Esophagitis (EOS-1)

Primary Purpose

Eosinophilic Esophagitis

Status

Completed

Phase

Phase 3

Locations

Germany

Study Type

Interventional

Intervention

Budesonide 1mg orodispersible tablet twice daily

Placebo orodispersible tablet twice daily

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

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.

Sites / Locations

Center for Digestive Diseases Eppendorf

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Budesonide

Placebo

Arm Description

Budesonide 1mg orodispersible tablet twice daily

Placebo orodispersible tablet twice daily

Outcomes

Primary Outcome Measures

Rate of clinico-pathological remission

Secondary Outcome Measures

Rate of patients with histological remission

Rate of patients with resolutions of symptoms measured by numerical rating score of symptoms

Full Information

NCT ID

NCT02434029

First Posted

April 30, 2015

Last Updated

February 2, 2017

Sponsor

Dr. Falk Pharma GmbH

1. Study Identification

Unique Protocol Identification Number

NCT02434029

Brief Title

Budesonide Orodispersible Tablet vs. Placebo in Active Eosinophilic Esophagitis

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2017

Overall Recruitment Status

Completed

Study Start Date

November 11, 2015 (Actual)

Primary Completion Date

August 4, 2016 (Actual)

Study Completion Date

October 4, 2016 (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 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.

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 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

88 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Budesonide

Arm Type

Experimental

Arm Description

Budesonide 1mg orodispersible tablet twice daily

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo orodispersible tablet twice daily

Intervention Type

Drug

Intervention Name(s)

Budesonide 1mg orodispersible tablet twice daily

Intervention Type

Drug

Intervention Name(s)

Placebo orodispersible tablet twice daily

Primary Outcome Measure Information:

Title

Rate of clinico-pathological remission

Time Frame

6 weeks

Secondary Outcome Measure Information:

Title

Rate of patients with histological remission

Time Frame

6 weeks

Title

Rate of patients with resolutions of symptoms measured by numerical rating score of symptoms

Time Frame

week 6

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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 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.

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

Plan to Share IPD

Citations:

PubMed Identifier

32721437

Citation

Straumann A, Lucendo AJ, Miehlke S, Vieth M, Schlag C, Biedermann L, Vaquero CS, Ciriza de Los Rios C, Schmoecker C, Madisch A, Hruz P, Hayat J, von Arnim U, Bredenoord AJ, Schubert S, Mueller R, Greinwald R, Schoepfer A, Attwood S; International EOS-2 Study Group. Budesonide Orodispersible Tablets Maintain Remission in a Randomized, Placebo-Controlled Trial of Patients With Eosinophilic Esophagitis. Gastroenterology. 2020 Nov;159(5):1672-1685.e5. doi: 10.1053/j.gastro.2020.07.039. Epub 2020 Jul 25.

Results Reference

derived

PubMed Identifier

30922997

Citation

Lucendo AJ, Miehlke S, Schlag C, Vieth M, von Arnim U, Molina-Infante J, Hartmann D, Bredenoord AJ, Ciriza de Los Rios C, Schubert S, Bruckner S, Madisch A, Hayat J, Tack J, Attwood S, Mueller R, Greinwald R, Schoepfer A, Straumann A; International EOS-1 Study Group. Efficacy of Budesonide Orodispersible Tablets as Induction Therapy for Eosinophilic Esophagitis in a Randomized Placebo-Controlled Trial. Gastroenterology. 2019 Jul;157(1):74-86.e15. doi: 10.1053/j.gastro.2019.03.025. Epub 2019 Mar 26.

Results Reference

derived

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Budesonide Orodispersible Tablet vs. Placebo in Active Eosinophilic Esophagitis

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