A study to investigate the efficacy and tolerance of budesonide tablets and suspension in patients suffering from esophagitis over a 14 day period
- Conditions
- Active eosinophilic esophagitisMedDRA version: 14.1Level: LLTClassification code 10064220Term: Eosinophilic esophagitisSystem Organ Class: 10017947 - Gastrointestinal disordersTherapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- EUCTR2009-016692-29-BE
- Lead Sponsor
- Dr. Falk Pharma GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 100
1.Signed informed consent,
2.Male or female patients, 18 to 75 years of age,
3.Confirmed clinicopathological diagnosis of EoE according to established diagnostic criteria
4.Active symptomatic and histological EoE
5.Negative pregnancy test in females of childbearing potential at screening visit 2,
6.Women of child-bearing potential have to apply during the entire duration of the study a highly effective method of birth control
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 90
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10
1.Clinically and endoscopically suspicion for gastroesophageal reflux disease, achalasia, or sklerodermia,
2.Gastroesophageal reflux disease and PPI-responsive esophageal eosinophilia,
3.Other clinical evident causes than EoE for esophageal eosinophilia,
4.Any concomitant esophageal disease and relevant gastro-intestinal disease,
5.Abnormal hepatic function, liver cirrhosis, or portal hypertension,
6.Abnormal renal function,
7.History of cancer in the last five years (except for non-metastatic
cancers, e.g., basalioma),
8.History of esophageal surgery at any time or of esophageal dilation procedures within the last 8 weeks prior to screening visit 2,
9.Upper gastrointestinal bleeding within 8 weeks prior to screening visit 2,
10.Concomitant, or within the 4 weeks prior to screening visit 2, treatment with systemic therapies for any reason that may affect assessment of primary and secondary endpoints, i.e., systemic glucocorticoids, histamine antagonists, mast cell stabilizers, leukotriene receptor antagonists, biologics, or immunosuppressants,
11.Concomitant, or within the 2 weeks prior to screening visit 2, treatment with topical therapies for any reason that may affect assessment of primary and secondary endpoints, i.e., topical glucocorticoids or inhaled sodium cromoglycate,
12.Installation of dietary restrictions within 4 weeks prior to screening visit 2 or during treatment,
13.Intake of grapefruit containing food or beverages during the treatment with study medication,
14.Known intolerance/hypersensitivity to study drug,
15.History of intolerance/hypersensitivity to propofol, soja or soja oil, saturated triglycerides, lecithin, egg or egg derivatives, if propofol will be used for sedation during endoscopy,
16.Existing 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 assess the efficacy of 2x1 mg/d or 2x2 mg/d budesonide effervescent tablets vs. 2x2 mg/d oral viscous budesonide suspension vs. placebo for the induction treatment of active eosinophilic esophagitis.;Secondary Objective: • To study safety and tolerability in the form of adverse events and laboratory parameters,<br>• To assess patients’ quality of life,<br>• To assess the patient's acceptance and preference of the study drugs.<br>;Primary end point(s): Primary efficacy endpoint:<br>Rate of histological remission at week 2 (LOCF)<br><br>Co-primary efficacy endpoint:<br>Change in the mean numbers of eos/mm2 hpf (eosinophil load) from baseline to week 2 (LOCF);Timepoint(s) of evaluation of this end point: week 2
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Secondary efficacy endpoints:<br>• Rate of histological response at week 2 (LOCF),<br>• Change in the Dysphagia Score,<br>• Adverse events;Timepoint(s) of evaluation of this end point: week 2