NCT02434029
Completed
Phase 3
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
ConditionsEosinophilic Esophagitis
Overview
- Phase
- Phase 3
- Intervention
- Budesonide 1mg orodispersible tablet twice daily
- Conditions
- Eosinophilic Esophagitis
- Sponsor
- Dr. Falk Pharma GmbH
- Enrollment
- 88
- Locations
- 1
- Primary Endpoint
- Rate of clinico-pathological remission
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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.
Investigators
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,
Arms & Interventions
Budesonide
Budesonide 1mg orodispersible tablet twice daily
Intervention: Budesonide 1mg orodispersible tablet twice daily
Placebo
Placebo orodispersible tablet twice daily
Intervention: Placebo orodispersible tablet twice daily
Outcomes
Primary Outcomes
Rate of clinico-pathological remission
Time Frame: 6 weeks
Secondary Outcomes
- Rate of patients with histological remission(6 weeks)
- Rate of patients with resolutions of symptoms measured by numerical rating score of symptoms(week 6)
Study Sites (1)
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