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Spontaneous study on the efficacy and safety of an oral viscous suspension of budesonide administered to children affected by eosinophilic esophagitis.

Spontaneous study on the efficacy and safety of an oral viscous suspension of budesonide administered to children affected by eosinophilic esophagitis.

Status
Unknown
Phases
Phase 2
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2014-002465-30-IT
Enrollment
Unknown
Registered
2014-06-24
Start date
Unknown
Completion date
Unknown
Last updated
2017-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Eosinophilic Esophagitis

Interventions

Product Name: Budesonide Product Code: Budesonide Pharmaceutical Form: Oral suspension INN or Proposed INN: BUDESONIDE CAS Number: 51333-22-3 Concentration unit: mg/ml milligram(s)/millilitre Concentr

Sponsors

Dip. Pediatria UOC Gastroenterologia ed Epatologia Pediatrica
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: patients of both gender aged below 18 yrs with diagnosis of eosinophilic esophagitis verified by histological examination of esophageal biopsies (eosinophil count >/= 15/HPF) Newly diagnosed patients or previously put under restricted diet or treated with fluticasone/budesonide nebulizer suspension with negative results or relapse. Are the trial subjects under 18? yes Number of subjects for this age range: 30 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Age > 18 yrs Patients with concomitant crhonic intestinal pathologies, heart or gut, respiratory or kidney malformations , neurological deficit, uncertain diagnosis of Eosinophilic Esophagitis

Design outcomes

Primary

MeasureTime frame
Main Objective: evaluate the efficacy of budesoniode treatment, a viscous oral suspension, in patiens affected with Eosinophilic Esophagitis, in whom other type of therapies have failed or patients with relapse, or newly diagnosed patients. Evaluate treatment safety in terms of adverse reactions or impact on the cortical-adrenal activity.;Secondary Objective: Not Applicable;Primary end point(s): Decrease of eosinophilic infiltration, evaluated by biopsy at 0, 12 and 36 (follow-up) weeks.;Timepoint(s) of evaluation of this end point: 0, 12 and 36 (follow-up) week—

Secondary

MeasureTime frame
Secondary end point(s): Not Applicable;Timepoint(s) of evaluation of this end point: Not Applicable—

Countries

Italy

Contacts

Public ContactUOC Gastroenterologia ed Epatologia

Dip. Pediatria

salvatore.cucchiara@uniroma1.it00390649979326

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026