Study title: A phase II, two-centre, open-label study in patients aged 3 months to 13 years with endoscopically-proven reflux oesophagitis.
Type of medicine: Medicines containing chemical active substances | |||||
Therapeutic area: Digestive System Diseases | |||||
Brands: Please see report | |||||
MAH holders: Please see report | |||||
Assessment: | |||||
Active substance: LANSOPRAZOLE | |||||
ATC code: A02BC03 | |||||
Document link: Lansoprazole_AG-II-95-028-Synopsis.pdf | |||||
Document date: 2011-10-14 | |||||
Study number: AG/II/95/028-EC384 | |||||
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 | Y | - |