Clinical trial with ZED1227 capsules compared to placebo in subjects with celiac disease during a 6-week treatment.
- Conditions
- Treatment of celiac diseaseMedDRA version: 20.0 Level: LLT Classification code 10007864 Term: Celiac disease System Organ Class: 100000004856Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- EUCTR2017-002241-30-FI
- Lead Sponsor
- Dr. Falk Pharma GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 160
• Documented initial biopsy proven diagnosis of celiac disease at least 12 months prior to screening,
• Human leukocyte antigen DQ (HLA-DQ) typing compatible with celiac disease
• Negative TG2-IgA serology
• Successful adherence to a gluten-free diet for at least 12 months
• Negative diagnosis of Helicobacter pylori infection
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 160
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
• Selective immunoglobulin A deficiency,
• IgE-specific antibodies against wheat or gliadin,
• Refractory celiac disease defined as persistent or recurrent malabsorptive symptoms and signs
• Severe complications of celiac disease
• Any concomitant diseases of the intestinal tract in addition to celiac disease
• Diabetes mellitus type 1
• Evidence of relevant systemic disease
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method