Evaluation of Safety and Tolerability of Creon Micro in Children Younger Than Four Years With Pancreatic Exocrine Insufficiency
Launched by ABBOTT PRODUCTS · Dec 10, 2012
Trial Information
Current as of July 23, 2025
Completed
Keywords
ClinConnect Summary
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 t...
Gender
ALL
Eligibility criteria
- 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
About Abbott Products
Abbott Products is a global healthcare company dedicated to advancing medical science and improving patient outcomes through innovative products and solutions. With a strong focus on research and development, Abbott engages in clinical trials to evaluate the safety and efficacy of its diverse portfolio, which includes diagnostics, medical devices, nutrition, and pharmaceuticals. Committed to upholding the highest ethical standards, Abbott collaborates with healthcare professionals and regulatory bodies to ensure rigorous study protocols and compliance, ultimately contributing to the advancement of healthcare worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Barnaul, , Russian Federation
Moscow, , Russian Federation
Novosibirsk, , Russian Federation
Novosibirsk, , Russian Federation
Orenburg, , Russian Federation
St. Petersburg, , Russian Federation
Tomsk, , Russian Federation
Voronezh, , Russian Federation
Yaroslavl, , Russian Federation
Patients applied
Trial Officials
Suntje Sander-Struckmeier, PhD
Study Director
Abbott
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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