clinical study to show equal clinical efficacy of two dosing regimen of budesonid orodispersible tablets (twice daily vs. once daily) for treatment of inflammation of the esophagus

Phase 1

• Conditions: eosinophilic esophagitis; MedDRA version: 20.1Level: PTClassification code 10064212Term: Eosinophilic oesophagitisSystem Organ Class: 10017947 - Gastrointestinal disorders; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2020-001314-37-AT
• Lead Sponsor: Dr. Falk Pharma GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-03-01
• Last Update Posted: 2 March 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 242

Inclusion Criteria

- Signed informed consent,
- Man or woman 18 to 75?years of age,
- Confirmed diagnosis of eosinophilic esophagitis (EoE)
- Active symptomatic and histological EoE
- At least 4?points in Patient’s Global Assessment (PatGA) concerning the severity of EoE symptoms at baseline visit,
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 196
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 46

Exclusion Criteria

- gastroesophageal reflux disease (GERD),
- Achalasia, scleroderma esophagus, or systemic sclerosis,
- clinically evident causes for esophageal eosinophilia other than EoE
- Any concomitant esophageal disease and relevant active gastro-intestinal disease
- abnormal laboratory values, presence of or suspected relevant concomitant disease(s), that could affect study-specific assessments and/or their evaluation, or might compromise patient's safety and/or compliance (e.g. severe organic or psychiatric diseases/disorders, infectious diseases associated with clinical signs, liver cirrhosis, portal hypertension, cardiovascular disease, diabetes mellitus, osteoporosis, active peptic ulcer disease
- History of cancer, gastrointestinal bleeding, esophageal surgery, esophageal dilation procedures or need for an immediate endoscopic intervention due to a stricture
- Diagnosis of chickenpox, herpes zoster, or measles within the last 3 months prior to baseline,
- Treatment with medication, that could compromise/influence the effects of the study treatment, assessment of the endpoints and/or patients' safety, during or within too narrow timeframe of the clinical trial (e.g. immunosuppressants, CYP3A4 inhibitors, live vaccination, non-stable treatment with proton pump inhibitors)
- exiting or intended pregnancy or breast-feeding

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To prove the non-inferiority of 1?x?2?mg/d vs. 2?x?1?mg/d budesonide orodispersible tablets for the induction of histological remission in adult patients with active eosinophilic esophagitis (EoE);Secondary Objective: - To further assess EoE-associated clinical, endoscopic, and histological findings after 6?weeks treatment with budesonide orodispersible tablets, <br>- To study safety and tolerability as assessed by adverse events and laboratory parameters, <br>- To assess patients’ quality of life;Primary end point(s): Proportion of patients with histological remission ;Timepoint(s) of evaluation of this end point: week 6

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1. Change in the peak eos/mm2 hpf from baseline to week?6 (LOCF), <br><br>2. Change in the severity of dysphagia<br><br>3. Change in the severity of odynophagia<br><br>4. Change of overall severity of EoE symptoms<br><br>5. Change in the total weekly Eosinophilic Esophagitis Activity Index;Timepoint(s) of evaluation of this end point: week 6 (for secondary endpoints 1 - 5)