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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01747330
Recruitment Status : Completed
First Posted : December 11, 2012
Results First Posted : July 15, 2014
Last Update Posted : July 15, 2014
Information provided by (Responsible Party):
Abbott ( Abbott Products )

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.

Condition or disease Intervention/treatment Phase
Pancreatic Exocrine Insufficiency Drug: Pancreatin Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : June 2012
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

Arm Intervention/treatment
Experimental: Creon micro, minimicrospheres Drug: Pancreatin
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 Name: Creon micro

Primary Outcome Measures :
  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 Outcome Measures :
  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)

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   up to 4 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01747330

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Russian Federation
Site Reference ID/Investigator# 80716
Barnaul, Russian Federation, 656019
Site Reference ID/Investigator# 80693
Moscow, Russian Federation, 117997
Site Reference ID/Investigator# 80698
Novosibirsk, Russian Federation, 630091
Site Reference ID/Investigator# 80713
Novosibirsk, Russian Federation
Site Reference ID/Investigator# 80715
Orenburg, Russian Federation, 460000
Site Reference ID/Investigator# 80694
St. Petersburg, Russian Federation, 194156
Site Reference ID/Investigator# 80714
Tomsk, Russian Federation, 634050
Site Reference ID/Investigator# 80697
Voronezh, Russian Federation, 394036
Site Reference ID/Investigator# 80696
Yaroslavl, Russian Federation, 150003
Sponsors and Collaborators
Abbott Products
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Study Director: Suntje Sander-Struckmeier, PhD Abbott
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Abbott Products Identifier: NCT01747330    
Other Study ID Numbers: M13-277
First Posted: December 11, 2012    Key Record Dates
Results First Posted: July 15, 2014
Last Update Posted: July 15, 2014
Last Verified: June 2014
Keywords provided by Abbott ( Abbott Products ):
cystic fibrosis
Additional relevant MeSH terms:
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Exocrine Pancreatic Insufficiency
Pancreatic Diseases
Digestive System Diseases
Gastrointestinal Agents