Evaluation of Safety and Tolerability of Creon Micro in Children Younger Than Four Years With Pancreatic Exocrine Insufficiency
Status and phase
Conditions
Treatments
Details and patient eligibility
About
The purpose of this study is to evaluate the safety and tolerability of Creon micro in children younger than four years with pancreatic exocrine insufficiency.
Full description
A prospective open-label, multi-center study evaluating safety and tolerability of Creon Micro in pediatric subjects from at least one month to less than four years of age with Pancreatic Exocrine Insufficiency (PEI) due to Cystic Fibrosis (CF). Referring to the European Medicines Agency (EMEA) pediatric age criteria for the purpose of the study, subjects are categorized as infants and toddlers (< 2 years) and children, (2 years to < 4 years). In total, 40 subjects will be enrolled (20 subjects in each age subgroup). Subjects receive their prescribed pancreatic enzyme supplementation at the individual dose until start of treatment with Creon Micro, if the subjects were on pancreatic enzyme supplementation before start of the study. Subjects will be treated with Creon Micro during the study. The treatment duration is 3 months.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Children younger than four years with confirmed cystic fibrosis diagnosis and a body weight of at least 2 kilograms
Exclusion criteria
- Ileus or acute abdomen
- history of fibrosing colonopathy
- history of distal ileal obstruction without surgery
- solid organ transplant or surgery affecting the large bowel, other than appendectomy
Trial design
Primary purpose
Allocation
Interventional model
Masking
40 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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