Clinical Trial: Evaluation of Safety and Tolerability of Creon Micro in Children Younger Than Four Years With Pancreatic Exocrine Insufficiency

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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 Ex

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 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 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.
Sponsor: Abbott Products

Current Primary Outcome:

  • Body Weight [ Time Frame: 3 months ]
    change from baseline at day 84
  • Height [ Time Frame: 3 months ]
    change from baseline at day 84
  • Stool Frequency [ Time Frame: 3 months ]
    Average daily stool frequency during treatment period: Number of bowel movements per day
  • Stool Consistency [ Time Frame: 3 months ]
    Assessment of stool consistency by the caregiver on a daily basis: hard, formed/normal, soft, watery
  • Subject's Acceptance of Treatment [ Time Frame: 3 months ]
    Acceptance to Creon Micro. The caregiver should give his/her opinion based on the following scale: very good, good, moderate, and unsatisfactory.


Original Primary Outcome:

  • Body Weight [ Time Frame: 3 months ]
  • Height [ Time Frame: 3 months ]
  • Stool Frequency [ Time Frame: 3 months ]
  • Stool Consistency [ Time Frame: 3 months ]
  • Subject's Acceptance of Treatment [ Time Frame: 3 months ]
    Acceptance to Creon Micro. The caregiver should give his/her opinion based on the following scale: very good, good, moderate, and unsatisfactory.


Current Secondary Outcome:

  • Number of Subjects With Adverse Events [ Time Frame: 4 months ]
  • Pulse [ Time Frame: 3 months ]
    Change from Baseline at Day 84
  • Number of Participants With Findings During Physical Examination [ Time Frame: 3 months ]
    A physical examination was conducted by the physician. All abnormal findings were recorded as medical histories if present prior to start of study drug or as AEs otherwise. There was no separate documentation of physical examination findings in this study.
  • Number of Participants With Clinical Relevant Safety Laboratory Values [ Time Frame: 3 months ]
    (hematology: hemoglobin, hematocrit, RBC count, WBC count, platelet count; biochemistry: glucose (fasting), creatinine, alkaline phosphatase, total bilirubin, ALAT (alanine amino transferase), ASAT (aspartate amino transferase), gamma-glutamyl transferase, uric acid, calcium, phosphate, potassium, serum pancreatic lipase; urinalysis (dipstick): glucose, blood, albumin, pH)


Original Secondary Outcome:

  • Number of Subjects With Adverse Events [ Time Frame: 4 months ]
  • Vital Signs [ Time Frame: 3 months ]
  • Physical Examination [ Time Frame: 3 months ]
    An evaluation of the body and its functions using inspection, palpation (feeling with the hands), percussion (tapping with the fingers), and auscultation (listening).
  • Safety Laboratory Values [ Time Frame: 3 months ]
    (hematology: hemoglobin, hematocrit, RBC count, WBC count, platelet count; biochemistry: glucose (fasting), creatinine, alkaline phosphatase, total bilirubin, ALAT (alanine amino transferase), ASAT (aspartate amino transferase), gamma-glutamyl transferase, uric acid, calcium, phosphate, potassium, serum pancreatic lipase; urinalysis (dipstick): glucose, blood, albumin, pH)


Information By: Abbott

Dates:
Date Received: November 23, 2012
Date Started: June 2012
Date Completion:
Last Updated: June 13, 2014
Last Verified: June 2014