Maintenance of Remission With Budesonide Orodispersible Tablets vs. Placebo in Eosinophilic Esophagitis

• Register: ClinicalTrials.gov
• Last refreshed on: 18 October 2021
• Main ID: NCT02493335
• Date of registration: 07/07/2015
• Prospective Registration: Yes
• Primary sponsor: Dr. Falk Pharma GmbH
• Public title: Maintenance of Remission With Budesonide Orodispersible Tablets vs. Placebo in Eosinophilic Esophagitis EOS-2
• Scientific 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
• Date of first enrolment: January 15, 2016
• Target sample size: 204
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02493335
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Germany

Contacts

• Name: Ralph Mueller, PhD
• Affiliation: Dr. Falk Pharma GmbH

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Eosinophilic Esophagitis

Intervention(s)

Drug: Budesonide 0.5mg orodispersible tablet twice daily

Drug: Budesonide 1mg orodispersible tablet twice daily

Drug: Placebo orodispersible tablet twice daily

Primary Outcome(s)

Rate of patients free of treatment failure after 48 weeks of treatment. [Time Frame: 48 weeks]

Secondary Outcome(s)

Rate of patients with histological relapse [Time Frame: 48 weeks]

Rate of patients with clinical relapse [Time Frame: 48 weeks]

Secondary ID(s)

BUL-2/EER

2014-001485-99

Source(s) of Monetary Support

Please refer to primary and secondary sponsors