Randomized Study of Pancrelipase With Bicarbonate (PANCRECARB) Capsules in Reducing Steatorrhea in Patients With Cystic Fibrosis
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|ClinicalTrials.gov Identifier: NCT00006063|
Recruitment Status : Completed
First Posted : July 6, 2000
Last Update Posted : June 24, 2005
I. Compare the efficacy of enteric coated pancrelipase with bicarbonate (PANCRECARB) capsules versus the patient's usual enteric coated pancreatic enzyme without bicarbonate in decreasing fecal fat and nitrogen losses in patients with cystic fibrosis.
|Condition or disease||Intervention/treatment||Phase|
|Cystic Fibrosis||Drug: pancrelipase with bicarbonate||Not Applicable|
PROTOCOL OUTLINE: This is a randomized, multicenter study. In the first treatment period, patients are randomized to one of two treatment arms.
Arm I: Patients receive enteric coated pancrelipase with bicarbonate (PANCRECARB) capsules before meals and snacks for 7 consecutive days.
Arm II: Patients receive their usual enteric coated pancreatic enzyme without bicarbonate capsule before meals and snacks for 7 consecutive days.
Patients receive approximately 50% of their usual lipase dose during treatment. Food intake is recorded on days 1-3, food intake is weighed and recorded on days 4-7, and stools are collected over 72 hours on days 5-7 to determine fecal fat and nitrogen excretion. Anthropometric measurements including height, weight, and skinfolds are assessed.
In the second treatment period, patients are switched to the alternate treatment arm after a 3 day washout period. Patients receive the opposing treatment as per protocol.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||24 participants|
|Study Start Date :||July 1999|
|Study Completion Date :||August 1999|
U.S. FDA Resources
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00006063
|Study Chair:||Mary Sue Brady||Indiana University School of Medicine|