Eosinophilic EsophagitisPhase 2NCT02280616

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

A Phase 2 study testing low dose budesonide tablet, high dose budesonide tablet and high dose budesonide suspension in people with Eosinophilic Esophagitis, run by Dr. Falk Pharma GmbH at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Eosinophilic Esophagitis
What is being tested?: low dose budesonide tablet, high dose budesonide tablet and high dose budesonide suspension
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 76 participants
Where: 1 siteGermany
Study dates: Jun 2011to May 2014
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

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

Trial locations and contacts

1 site in 1 country.

Germany1 site

Center for Digestive Diseases Eppendorf
Hamburg, 20249

Other trials in Germany

About this study

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

Conditions: Eosinophilic Esophagitis
Being tested: low dose budesonide tablet, high dose budesonide tablet, high dose budesonide suspension, Placebo
Medical subject headings: Eosinophilic Esophagitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

low dose budesonide tabletDrug
Also called BET 1mg BID
1mg budesonide tablet twice daily AND 5ml placebo suspension twice daily
high dose budesonide tabletDrug
Also called BET 2mg BID
2mg budesonide tablet twice daily AND 5ml placebo suspension twice daily
high dose budesonide suspensionDrug
Also called BVS 2mg BID
placebo tablet twice daily AND 5ml [0.4mg budesonide/ml] suspension twice daily
PlaceboDrug
placebo tablet twice daily AND 5ml placebo suspension twice daily

Study groups in NCT02280616
Study group	Role	What they receive
Low dose budesonide tablet	Experimental	Not described Receives: Drug: low dose budesonide tablet
High dose budesonide tablet	Experimental	Not described Receives: Drug: high dose budesonide tablet
High dose budesonide suspension	Experimental	Not described Receives: Drug: high dose budesonide suspension
Placebo	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Rate of histological remission
Measured: 2 weeks (LOCF)
Change in the mean numbers of eos
Measured: 2 weeks (LOCF)

Secondary outcomes (1)

Change in the mean numbers of eos
Measured: 2 weeks (LOCF)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2011May 2014

First posted31 Oct 2014 (estimated)
Study startJun 2011
Primary completionApr 2013
Study completionMay 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Eosinophilic EsophagitisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 76 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02280616
Sponsor's protocol ID: BUU-2/EEA
Other IDs: 2009-016692-29, 2009
Status last verified: Jan 2016
First submitted: 29 Oct 2014
Last updated: 21 Jan 2016
Results posted: No
Data monitoring committee: Yes

Publications

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.
PubMed 25792708

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
The Esophageal String Test as a Diagnostic Screening Tool for Eosinophilic Esophagitis Among Africans With Dysphagia in Mali and the United States
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Active, not recruitingPhase 3
Efficacy and Safety of Tezepelumab in Patients With Eosinophilic Esophagitis
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Natural History and Genetics of Food Allergy and Related Conditions
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Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
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Patient-Centered Decision Support for Eosinophilic Esophagitis
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All Eosinophilic Esophagitis trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02280616
Acronym / sponsor ID: BUU-2/EEA
Conditions: Eosinophilic Esophagitis
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 76 participants (actual)
Lead sponsor: Dr. Falk Pharma GmbHIndustry (pharma, biotech, devices)
Study start: Jun 2011
Primary completion: Apr 2013 (actual)
Study completion: May 2014 (actual)
First posted: 31 Oct 2014 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Low dose budesonide tablet	Experimental	Drug: low dose budesonide tablet
High dose budesonide tablet	Experimental	Drug: high dose budesonide tablet
High dose budesonide suspension	Experimental	Drug: high dose budesonide suspension
Placebo	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
low dose budesonide tabletAlso: BET 1mg BID1mg budesonide tablet twice daily AND 5ml placebo suspension twice daily	Drug	Low dose budesonide tablet
high dose budesonide tabletAlso: BET 2mg BID2mg budesonide tablet twice daily AND 5ml placebo suspension twice daily	Drug	High dose budesonide tablet
high dose budesonide suspensionAlso: BVS 2mg BIDplacebo tablet twice daily AND 5ml [0.4mg budesonide/ml] suspension twice daily	Drug	High dose budesonide suspension
Placeboplacebo tablet twice daily AND 5ml placebo suspension twice daily	Drug	Placebo

Primary outcome

Rate of histological remission
Time frame: 2 weeks (LOCF)
Change in the mean numbers of eos
Time frame: 2 weeks (LOCF)

1 secondary outcome

Change in the mean numbers of eos
Time frame: 2 weeks (LOCF)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2016.
Results publication: PubMed 25792708Miehlke 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.

Related trials for Eosinophilic Esophagitis

Recruiting
The Esophageal String Test as a Diagnostic Screening Tool for Eosinophilic Esophagitis Among Africans With Dysphagia in Mali and the United States
Dysphagia, Eosinophilic Esophagitis
Active, not recruitingPhase 3
Efficacy and Safety of Tezepelumab in Patients With Eosinophilic Esophagitis
Eosinophilic Esophagitis
RecruitingObservational study
Natural History and Genetics of Food Allergy and Related Conditions
Food Allergy, Loeys-Dietz Syndrome
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Active, not recruiting
Patient-Centered Decision Support for Eosinophilic Esophagitis
Eosinophilic Esophagitis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ralph Mueller, PhD study director

Dr. Falk Pharma GmbH

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of histological remission (time frame: 2 weeks (LOCF)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02280616, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2016.