Chronic Viral Hepatitis B, Alcoholic Liver Disease, MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease) / MASH, Metabolic Dysfunction-Associated Steatohepatitis
Conditions
Brief summary
Changes in overall symptoms evaluation using the GOS score
Detailed description
Changes in key individual symptoms using the GOS scale, Change in CLDQ global score, Incidence and severity of TEAEs
Interventions
DRUGTest Placebo: The placebo is for the test product i.e.
DRUGESSENTIALE Advance
DRUGoily liquid in stick packs - 1.8g.
The placebo has different qualitative and quantitative composition as the test product
DRUGbut no differentiation could be made as both placebo and test products have the same appearance
DRUGtaste
DRUGsmell and mouthfeel
DRUGand packaged in the same primary packaging i.e.
DRUGstick packs
DRUGallowing the non-differentiation.
DRUGComparator Placebo: Standard placebo which has a different qualitative and quantitative composition from the marketed verum formulation Essentiale® 300 mg capsules but for which aspect of hard capsules is the same
DRUGEssentiale Forte
DRUG300 mg
DRUGkapsułki
DRUGNC0304 Phosphatidylcholine
Sponsors
Opella Healthcare Group S.A.S.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in overall symptoms evaluation using the GOS score | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in key individual symptoms using the GOS scale, Change in CLDQ global score, Incidence and severity of TEAEs | — |
Countries
Bulgaria, Germany, Poland
Outcome results
None listed