Maintenance of Remission With Budesonide Orodispersible Tablets vs. Placebo in Eosinophilic Esophagitis (EOS-2)

Dr. Falk Pharma

Status and phase: Completed; Phase 3

Conditions: Eosinophilic Esophagitis

Treatments: Drug: Budesonide 0.5mg orodispersible tablet twice daily; Drug: Budesonide 1mg orodispersible tablet twice daily; Drug: Placebo orodispersible tablet twice daily

Study type: Interventional

Funder types: Industry

Identifiers

NCT02493335

BUL-2/EER

2014-001485-99 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to prove the superiority of a 48-weeks treatment with budesonide orodispersible tablets versus placebo for the maintenance of clinico-pathological remission in patients with eosinophilic esophagitis.

Enrollment: 204 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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
• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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204 participants in 3 patient groups, including a placebo group

Budesonide 0.5mg orodispersible tablet twice daily

Experimental group

Description:

Budesonide 0.5mg orodispersible tablet twice daily

Treatment:

Drug: Budesonide 0.5mg orodispersible tablet twice daily

Budesonide 1mg orodispersible tablet twice daily

Experimental group

Description:

Budesonide 1mg orodispersible tablet twice daily

Treatment:

Drug: Budesonide 1mg orodispersible tablet twice daily

Placebo orodispersible tablet twice daily

Placebo Comparator group

Description:

Placebo orodispersible tablet twice daily

Treatment:

Drug: Placebo orodispersible tablet twice daily