Assessment of elemental impurities level after chronic administration of Diosmectite (SMECTA®) in subjects with chronic diarrhoea.<br>
Completed
- Conditions
- chronische diarree.chronic diarrhea
- Registration Number
- NL-OMON43250
- Lead Sponsor
- Ipsen Pharma SAS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 35
Inclusion Criteria
male or female patients with chronic diarrhea
18 - 60 years of age, inclusive
BMI 19 - 32 kilograms/meter2
non smokers
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To assess the concentration of lead in blood, one of the Class I impurities<br /><br>defined by ICH Q3D guidelines, after chronic administration of Smecta® in<br /><br>subjects with chronic functional diarrhoea.</p><br>
- Secondary Outcome Measures
Name Time Method <p>* To assess blood concentration of other Class I and IIa elemental impurities<br /><br>of interest (i.e. arsenic, cadmium, mercury, cobalt, vanadium, nickel<br /><br>and barium) and of aluminium after chronic administration of Smecta® in<br /><br>subjects with chronic functional diarrhoea;<br /><br>* To assess urinary lead levels and urinary levels of other selected Class I<br /><br>and IIa elemental impurities of interest (i.e. arsenic, cadmium, mercury,<br /><br>cobalt, vanadium, nickel and barium), and aluminium after chronic<br /><br>administration of Smecta®;<br /><br>* To further assess the safety and tolerance of Smecta® after chronic<br /><br>administration. </p><br>