Double-blind, randomized, placebo-controlled, Phase II/III trial on the efficacy and tolerability of treatment with budesonide oral suspension vs. placebo in children and adolescents with eosinophilic esophagitis

Phase 2

Completed

• Conditions: eosinophilic eosphagitis; eosinophylic gullet inflammation; 10017969

• Registration Number: NL-OMON50028
• Lead Sponsor: Dr. Falk Pharma GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 9

Inclusion Criteria

Inclusion criteria for DB-treatment phase:
- Signed informed consent
- Male or female patients, >=2 to <18 years of age
- Confirmed clinico-pathological diagnosis of EoE according to established
diagnostic criteria
- Clinically and histologically active EoE
- Negative pregnancy test in female patients of childbearing potential

Exclusion Criteria

Exclusion criteria for DB treatment phase:
- Erosive gastroesophageal reflux disease (GERD)
- 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 untreated or inadequately treated fungal infection
[candida esophagitis])
- Any known relevant infectious diseases (e.g., AIDS defining disease, active
tuberculosis, hepatitis B, or hepatitis C)
- Diabetes mellitus
- If careful medical monitoring is not ensured: cardiovascular disease,
hypertension, osteoporosis, active peptic ulcer disease, glaucoma, cataract, or
infection
- History of cancer in the last five years
- History of esophageal surgery at any time or of esophageal dilation
procedures within the last 4 weeks prior to screening endoscopy, or need for an
immediate endoscopic intervention due to a stricture
- Upper gastrointestinal bleeding within 8 weeks prior to screening endoscopy
- Existing or intended pregnancy or breast-feeding

Study & Design

• Study Type: Interventional
• Study Design: Not specified