Study title: A Phase II, open-label, parallel group, 8-12 weeks study to assess the safety and efficacy of once daily administration of lansoprazole 15 mg or 30 mg in male and female adolescents aged 12 to 17 years with GERD including non-erosive GERD and erosive 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_M00-158-Synopsis.pdf | |||||
Document date: 2011-10-14 | |||||
Study number: M00-158 | |||||
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 |