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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: |
NCT00775528 |
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Date of registration:
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17/10/2008 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Study Investigating a Delayed-Release Pancrelipase in Patients With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis
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Scientific title:
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An Open Label, Multi-center, Study to Assess the Safety and Tolerability of Pancrelipase Delayed Release Capsules in Infants and Children Less Than 7 Years of Age With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis |
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Date of first enrolment:
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April 2009 |
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Target sample size:
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19 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00775528 |
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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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United States
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Contacts
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Name:
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Global Clinical Director Solvay |
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Address:
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Telephone:
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Email:
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Affiliation:
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Solvay Pharmaceuticals |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Confirmed Cystic Fibrosis (CF) diagnosis by two positive chloride sweat tests or gene
analysis
- Current or historical human fecal elastase < 50µg/gstool
- Weight greater than 3.75 kg
- Age 1 month to 6 years
- Currently receiving treatment with a commercially available pancreatic enzyme product
on a stable dose for more than 3 months
- Clinically stable condition without evidence of acute respiratory disease or any other
acute condition
Exclusion Criteria:
- Ileus or acute abdomen
- History of fibrosing colonopathy, Celiac disease, gastrectomy, Crohn´s disease and
small bowel surgery other than minor resection due to meconium ileus without resulting
in malabsorption syndrome
- History of distal ileal obstruction syndrome within 6 months of enrollment
- Use of an immunosuppressive drug
- Any type of malignancy involving the digestive tract in the last 5 years
- Known infection with HIV
Age minimum:
1 Month
Age maximum:
6 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Cystic Fibrosis
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Pancreatic Exocrine Insufficiency
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Intervention(s)
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Drug: Pancrelipase Delayed Release
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Primary Outcome(s)
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Number of Patients With at Least One Treatment Emergent Adverse Event (TEAE)
[Time Frame: 10 Days]
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Secondary Outcome(s)
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Fat Intake (g)
[Time Frame: Last 3 days in a 10-day treatment period]
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Stool Fat (% Fat)
[Time Frame: Last 3 days in a 10-day treatment period]
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Total Calorie Intake (kcal)
[Time Frame: Last 3 days in a 10-day treatment period]
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Secondary ID(s)
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S245.3.128
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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