Study title: A double blind, multi-centre, randomised, placebo-controlled study to assess the efficacy,tolerability and compliance profile of a triple therapy regimen (lansoprazole, amoxicilline and tinidazole) in comparison with the standard double therapy (amoxicilline and tinidazole), given for one week to children with Hpylori gastritis.
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_HP-AG-97-01-EC428-Synopsis.pdf | |||||
Document date: 2011-10-14 | |||||
Study number: HP/AG/97/01-EC428 | |||||
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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