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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abbott ( Abbott Products )
ClinicalTrials.gov Identifier:
NCT01747330
First received: November 23, 2012
Last updated: June 13, 2014
Last verified: June 2014
  Purpose

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 Intervention Phase
Pancreatic Exocrine Insufficiency
Drug: Pancreatin
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • Body Weight [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    change from baseline at day 84

  • Height [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    change from baseline at day 84

  • Stool Frequency [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Average daily stool frequency during treatment period: Number of bowel movements per day

  • Stool Consistency [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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:
  • Number of Subjects With Adverse Events [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
  • Pulse [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    Change from Baseline at Day 84

  • Number of Participants With Findings During Physical Examination [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    (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)


Enrollment: 40
Study Start Date: June 2012
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   up to 4 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01747330

Locations
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
Investigators
Study Director: Suntje Sander-Struckmeier, PhD Abbott
  More Information

No publications provided

Responsible Party: Abbott ( Abbott Products )
ClinicalTrials.gov Identifier: NCT01747330     History of Changes
Other Study ID Numbers: M13-277
Study First Received: November 23, 2012
Results First Received: December 23, 2013
Last Updated: June 13, 2014
Health Authority: Russia: Ministry of Health of the Russian Federation

Keywords provided by Abbott:
cystic fibrosis

Additional relevant MeSH terms:
Cystic Fibrosis
Exocrine Pancreatic Insufficiency
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pancreatin
Pancrelipase
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014