Study title: An open, randomized group comparative study with lactulose syrup (Duphalac~ versus lactulose crystalline in constipated children.
Type of medicine: Medicines containing chemical active substances | |||||
Therapeutic area: Digestive System Diseases [C06] | |||||
Brands: Please see report | |||||
MAH holders: Please see report, Please see report | |||||
Assessment: | |||||
Active substance: LACTULOSE | |||||
ATC code: | |||||
Document link: Lactulose-H.105.910NL.pdf | |||||
Document date: 2011-09-16 | |||||
Study number: H.l05.910 NL | |||||
EudraCT number: | |||||
Scope of study: Clinical | |||||
Population of study subjects: | Preterm newborn Infants | Newborn infants (1 to 27 days) | Infants and toddlers (28 days to 24 months) | Children (2 to 11 years) | Adolescents (12 to 18 years) |
- | - | - | Y | - |