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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT01747330 |
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Date of registration:
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23/11/2012 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Evaluation of Safety and Tolerability of Creon Micro in Children Younger Than Four Years With Pancreatic Exocrine Insufficiency
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Scientific title:
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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 |
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Date of first enrolment:
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June 2012 |
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Target sample size:
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40 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01747330 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 3
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Countries of recruitment
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Russian Federation
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Contacts
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Name:
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Suntje Sander-Struckmeier, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Abbott |
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Key inclusion & exclusion criteria
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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
Age minimum:
N/A
Age maximum:
4 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Pancreatic Exocrine Insufficiency
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Intervention(s)
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Drug: Pancreatin
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Primary Outcome(s)
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Body Weight
[Time Frame: 3 months]
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Stool Consistency
[Time Frame: 3 months]
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Height
[Time Frame: 3 months]
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Subject's Acceptance of Treatment
[Time Frame: 3 months]
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Stool Frequency
[Time Frame: 3 months]
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Secondary Outcome(s)
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Number of Subjects With Adverse Events
[Time Frame: 4 months]
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Number of Participants With Findings During Physical Examination
[Time Frame: 3 months]
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Pulse
[Time Frame: 3 months]
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Number of Participants With Clinical Relevant Safety Laboratory Values
[Time Frame: 3 months]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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