- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01747330
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
Conditions
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
-
-
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Barnaul, Russian Federation, 656019
- Site Reference ID/Investigator# 80716
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Moscow, Russian Federation, 117997
- Site Reference ID/Investigator# 80693
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Novosibirsk, Russian Federation, 630091
- Site Reference ID/Investigator# 80698
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Novosibirsk, Russian Federation
- Site Reference ID/Investigator# 80713
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Orenburg, Russian Federation, 460000
- Site Reference ID/Investigator# 80715
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St. Petersburg, Russian Federation, 194156
- Site Reference ID/Investigator# 80694
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Tomsk, Russian Federation, 634050
- Site Reference ID/Investigator# 80714
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Voronezh, Russian Federation, 394036
- Site Reference ID/Investigator# 80697
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Yaroslavl, Russian Federation, 150003
- Site Reference ID/Investigator# 80696
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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:
|
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
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3 months
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Height
Time Frame: 3 months
|
change from baseline at day 84
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3 months
|
Stool Frequency
Time Frame: 3 months
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Average daily stool frequency during treatment period: Number of bowel movements per day
|
3 months
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Stool Consistency
Time Frame: 3 months
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Assessment of stool consistency by the caregiver on a daily basis: hard, formed/normal, soft, watery
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3 months
|
Subject's Acceptance of Treatment
Time Frame: 3 months
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Acceptance to Creon Micro.
The caregiver should give his/her opinion based on the following scale: very good, good, moderate, and unsatisfactory.
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3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Subjects With Adverse Events
Time Frame: 4 months
|
4 months
|
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Pulse
Time Frame: 3 months
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Change from Baseline at Day 84
|
3 months
|
Number of Participants With Findings During Physical Examination
Time Frame: 3 months
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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.
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3 months
|
Number of Participants With Clinical Relevant Safety Laboratory Values
Time Frame: 3 months
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(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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- M13-277
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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