Study title: A phase I, multi-centre, double-blind, randomized study consisting of a 7-day pre-treatment period and a 5-day treatment period of either lansoprazole 15mg or 30mg (capsules) in 12-17 year-olds with symptomatic, endoscopically (oesophagitis grade ³1) and/or histologically proven (borderline or abnormal from oesophageal biopsies) GERD.
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_M97-640-Synopsis.pdf | |||||
Document date: 2011-10-14 | |||||
Study number: M97-640 | |||||
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) |
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