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Completed

NCT Number: NCT01747330

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

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.

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Key information

Conditions

Pancreatic Exocrine Insufficiency Congenital, Hereditary, and Neonatal Diseases and Abnormalities Cystic Fibrosis Digestive System Diseases Exocrine Pancreatic Insufficiency Genetic Diseases, Inborn Infant, Newborn, Diseases Lung Diseases Pancreatic Diseases Respiratory Tract Diseases

Age range

Up to 4 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Site Reference ID/Investigator# 80716, Barnaul, Russia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pancreatin

Drug

Doses of Pancreatin <2500 lipase u/kg/feed or <4000 lipase U/g fat/intake or <10000 lipase U/kg/day given orally are used

Other names: Creon micro

Primary outcomes

  1. Body Weight

    Time frame: 3 months

    change from baseline at day 84

  2. Height

    Time frame: 3 months

    change from baseline at day 84

  3. Stool Frequency

    Time frame: 3 months

    Average daily stool frequency during treatment period: Number of bowel movements per day

  4. Stool Consistency

    Time frame: 3 months

    Assessment of stool consistency by the caregiver on a daily basis: hard, formed/normal, soft, watery

  5. 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.

Secondary outcomes

  1. Number of Subjects With Adverse Events

    Time frame: 4 months

  2. Pulse

    Time frame: 3 months

    Change from Baseline at Day 84

  3. 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.

  4. 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)

Sponsors and collaborators

Lead sponsor

Abbott Products

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Dec 11, 2012
Registry last updated
Jul 15, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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