Celiac Disease
Conditions
Brief summary
Change in CDSD GI Specific Symptom Score (diarrhoea, abdominal pain, bloating, nausea) from Baseline Visit B (V2, Wk 3) to V5 (Wk 15).
Detailed description
Change in VH: CrD from Baseline Visit A (V1, Wk 0) to V5 (Wk 15),, Change in CDSD Non-Stool GI Symptom Score (abdominal pain, bloating, nausea) from Baseline Visit B (V2, Wk 3) to V5 (Wk 15),, Change in duodenal mucosal inflammation measured as the density of CD3-positive intraepithelial lymphocytes (IELs) from Baseline Visit A (V1, Wk 0) to V5 (Wk 15).
Interventions
DRUGPlacebo matching with ZED1227 capsules of Dr. Falk Pharma GmbH
DRUGCEC03
DRUGCEC02
Sponsors
Dr. Falk Pharma GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in CDSD GI Specific Symptom Score (diarrhoea, abdominal pain, bloating, nausea) from Baseline Visit B (V2, Wk 3) to V5 (Wk 15). | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in VH: CrD from Baseline Visit A (V1, Wk 0) to V5 (Wk 15),, Change in CDSD Non-Stool GI Symptom Score (abdominal pain, bloating, nausea) from Baseline Visit B (V2, Wk 3) to V5 (Wk 15),, Change in duodenal mucosal inflammation measured as the density of CD3-positive intraepithelial lymphocytes (IELs) from Baseline Visit A (V1, Wk 0) to V5 (Wk 15). | — |
Countries
Austria, Croatia, Finland, Germany, Norway, Poland, Romania, Spain, Sweden
Outcome results
None listed