Clinical trial NCT01747330: Evaluation of Safety and Tolerability of Creon Micro in Children Younger Than Four Years With Pancreatic Exocrine Insufficiency
Official title: An Open Label, Multicenter 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 Due to Cystic Fibrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pancreatic Exocrine Insufficiency
Keywords: cystic fibrosis
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2012-12-11
Enrollment: 40
Sex: ALL
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

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

Primary outcomes:
measure: Body Weight
timeFrame: 3 months
measure: Height
timeFrame: 3 months
measure: Stool Frequency
timeFrame: 3 months
measure: Stool Consistency
timeFrame: 3 months
measure: Subject's Acceptance of Treatment
timeFrame: 3 months
Secondary outcomes:
measure: Number of Subjects With Adverse Events
timeFrame: 4 months
measure: Pulse
timeFrame: 3 months
measure: Number of Participants With Findings During Physical Examination
timeFrame: 3 months
measure: Number of Participants With Clinical Relevant Safety Laboratory Values
timeFrame: 3 months
Other outcomes:
Locations:
city: Barnaul
country: Russian Federation
facility: Site Reference ID/Investigator# 80716
city: Moscow
country: Russian Federation
facility: Site Reference ID/Investigator# 80693
city: Novosibirsk
country: Russian Federation
facility: Site Reference ID/Investigator# 80698
city: Novosibirsk
country: Russian Federation
facility: Site Reference ID/Investigator# 80713
city: Orenburg
country: Russian Federation
facility: Site Reference ID/Investigator# 80715
city: St. Petersburg
country: Russian Federation
facility: Site Reference ID/Investigator# 80694
city: Tomsk
country: Russian Federation
facility: Site Reference ID/Investigator# 80714
city: Voronezh
country: Russian Federation
facility: Site Reference ID/Investigator# 80697
city: Yaroslavl
country: Russian Federation
facility: Site Reference ID/Investigator# 80696
Study officials:
affiliation: Abbott
name: Suntje Sander-Struckmeier, PhD
role: STUDY_DIRECTOR
References:
citation: Kashirskaya NY, Kapranov NI, Sander-Struckmeier S, Kovalev V. Safety and efficacy of Creon(R) micro in children with exocrine pancreatic insufficiency due to cystic fibrosis. J Cyst Fibros. 2015 Mar;14(2):275-81. doi: 10.1016/j.jcf.2014.07.006. Epub 2014 Jul 25.