Obesity
Conditions
Brief summary
The difference in total GITE1 score between EMP16 combined with Vi-Siblin® S and conventional orlistat combined with placebo dietary fibre supplement
Detailed description
Presence and participant rated severity of the individual GITE components: •oily spotting •faecal incontinence (including flatulence with discharge) •diarrhoea, Presence and Investigator-rated severity of GI-related AEs. all events jointly and individually, i.e. for: •oily spotting •faecal incontinence (including flatulence with discharge) •diarrhoea
Interventions
DRUGVi-Siblin S granulat
DRUGalli 60 mg hard capsules
DRUGDietary fibre supplement
Placebo - Maltodextrin
Sponsors
Empros Pharma AB
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The difference in total GITE1 score between EMP16 combined with Vi-Siblin® S and conventional orlistat combined with placebo dietary fibre supplement | — |
Secondary
| Measure | Time frame |
|---|---|
| Presence and participant rated severity of the individual GITE components: •oily spotting •faecal incontinence (including flatulence with discharge) •diarrhoea, Presence and Investigator-rated severity of GI-related AEs. all events jointly and individually, i.e. for: •oily spotting •faecal incontinence (including flatulence with discharge) •diarrhoea | — |
Countries
Sweden
Outcome results
None listed