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Clinical Trials/NL-OMON50028
NL-OMON50028
Completed
Phase 2

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 - BUU-5/EEA

Dr. Falk Pharma GmbH0 sites9 target enrollmentTBD
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Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Not specified
Sponsor
Dr. Falk Pharma GmbH
Enrollment
9
Status
Completed
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Eligibility Criteria

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)

Outcomes

Primary Outcomes

Not specified

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