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

June 13, 2014 updated by: Abbott Products

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

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.

Study Overview

Status

Completed

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Barnaul, Russian Federation, 656019
        • Site Reference ID/Investigator# 80716
      • Moscow, Russian Federation, 117997
        • Site Reference ID/Investigator# 80693
      • Novosibirsk, Russian Federation, 630091
        • Site Reference ID/Investigator# 80698
      • Novosibirsk, Russian Federation
        • Site Reference ID/Investigator# 80713
      • Orenburg, Russian Federation, 460000
        • Site Reference ID/Investigator# 80715
      • St. Petersburg, Russian Federation, 194156
        • Site Reference ID/Investigator# 80694
      • Tomsk, Russian Federation, 634050
        • Site Reference ID/Investigator# 80714
      • Voronezh, Russian Federation, 394036
        • Site Reference ID/Investigator# 80697
      • Yaroslavl, Russian Federation, 150003
        • Site Reference ID/Investigator# 80696

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 4 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Creon micro, minimicrospheres
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body Weight
Time Frame: 3 months
change from baseline at day 84
3 months
Height
Time Frame: 3 months
change from baseline at day 84
3 months
Stool Frequency
Time Frame: 3 months
Average daily stool frequency during treatment period: Number of bowel movements per day
3 months
Stool Consistency
Time Frame: 3 months
Assessment of stool consistency by the caregiver on a daily basis: hard, formed/normal, soft, watery
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.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Subjects With Adverse Events
Time Frame: 4 months
4 months
Pulse
Time Frame: 3 months
Change from Baseline at Day 84
3 months
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.
3 months
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)
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (ACTUAL)

December 1, 2012

Study Completion (ACTUAL)

December 1, 2012

Study Registration Dates

First Submitted

November 23, 2012

First Submitted That Met QC Criteria

December 10, 2012

First Posted (ESTIMATE)

December 11, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

July 15, 2014

Last Update Submitted That Met QC Criteria

June 13, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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