This study will assess the effect of pancrelipase delayed release 12,000 unit capsules on fat and nitrogen absorption in subjects 7 - 11 with pancreatic exocrine insufficiency due to Cystic Fibrosis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
17
12,000 unit Capsules, dosed individually based on fat intake.
Placebo
Site 2
Iowa City, Iowa, United States
Site 5
Louisville, Kentucky, United States
Site 9
Boston, Massachusetts, United States
Site 6
Ann Arbor, Michigan, United States
Coefficient of Fat Absorption (%)
This coefficient is calculated from fat intake and fat excretion : 100\*\[fat intake-fat excretion\]/fat intake. Stools were collected on 3 days during the 5 days treatment period. Higher values indicate a better response.
Time frame: 5 days
Coefficient of Nitrogen Absorption (%)
This coefficient is calculated from nitrogen intake and nitrogen excretion : 100\*\[nitrogen intake-nitrogen excretion\]/nitrogen intake. Stools were collected on 3 days during the 5 days treatment period. Higher values indicate a better response.
Time frame: 5 days
Total Fat Excretion (Grams)
Total amount of fat excreted during the stool collection period. Stools were collected on 3 days during the 5 days treatment period. Lower values indicate a better response.
Time frame: 5 days
Total Stool Weight (Grams)
Total weight of the stools collected during the stool collection period. Stools were collected on 3 days during the 5 days treatment period. Lower values indicate a better response.
Time frame: 5 days
Stool Frequency
Stool frequency is the average of the daily number of stools recorded during the treatment period. Lower values indicate a better response.
Time frame: 5 days
Percentage of Days With no Flatulence.
The percentage of days with no flatulence is calculated from the diary during the treatment period: 100\*(number of days with no flatulence/number of days recorded in diary). Higher values indicate a better response.
Time frame: 5 days
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Site 4
Minneapolis, Minnesota, United States
Site 8
Albuquerque, New Mexico, United States
Site 1
Cincinnati, Ohio, United States
Site 10
Oklahoma City, Oklahoma, United States
Site 7
Oklahoma City, Oklahoma, United States
Site 3
Hershey, Pennsylvania, United States
Percentage of Days With Formed/Normal Stools.
The percentage of days with formed/normal stools is calculated from the diary during the treatment period: 100\*(number of days with formed/normal stools/number of days with any stool). Higher values indicate a better response.
Time frame: 5 days
Percentage of Days With no Abdominal Pain.
The percentage of days with no abdominal pain is calculated from the diary during the treatment period: 100\*(number of days with no abdominal pain / number of days recorded in diary). Higher values indicate a better response.
Time frame: 5 days