chronische diarree. chronic diarrhea
Conditions
Interventions
Diosmectite (Smecta® 3g/sachet, powder for oral suspension. Three sachets per
day (TID). (morning, noon, and evening).
For the purpose of this study, Smecta® should be taken fasting and at least one
chronic diarrhea
Sponsors
Ipsen Pharma SAS
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: male or female patients with chronic diarrhea 18 - 60 years of age, inclusive BMI 19 - 32 kilograms/meter2 non smokers
Exclusion criteria
Exclusion criteria: Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of participation in another drug study within 90 days before the start of this study or being a blood donor within 60 days from the start of the study. In case of donating more than 1.5 liters of blood in the 10 months prior the start of this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the concentration of lead in blood, one of the Class I impurities defined by ICH Q3D guidelines, after chronic administration of Smecta® in subjects with chronic functional diarrhoea. | — |
Secondary
| Measure | Time frame |
|---|---|
| * To assess blood concentration of other Class I and IIa elemental impurities of interest (i.e. arsenic, cadmium, mercury, cobalt, vanadium, nickel and barium) and of aluminium after chronic administration of Smecta® in subjects with chronic functional diarrhoea; * To assess urinary lead levels and urinary levels of other selected Class I and IIa elemental impurities of interest (i.e. arsenic, cadmium, mercury, cobalt, vanadium, nickel and barium), and aluminium after chronic administration of Smecta®; * To further assess the safety and tolerance of Smecta® after chronic administration. | — |
Countries
The Netherlands
Outcome results
None listed