Study title: HDM9007 - Clinical observation to evaluate the patient oriented dosages of Palladon® retard with respect to circadian variations in pain intensity (0.1% of patients 10-19 years) (Germany); Protocol No.011-004: Open label, preliminary evaluation of the clinical effectiveness and steady state pharmacokinetics of a controlled release sprinkle formulation of hydromorphone in pediatric patients with chronic cancer pain. (terminated - lack of recruitment)
Type of medicine: Medicines containing chemical active substances | |||||
Therapeutic area: Anesthesia and Analgesia [E03] | |||||
Brands: Please see report | |||||
MAH holders: Please see report | |||||
Assessment: | |||||
Active substance: HYDROMORPHONE | |||||
ATC code: | |||||
Document link: | |||||
Document date: | |||||
Study number: Protocol No.011-004 | |||||
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 | - |