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Study Name: Pancrecarb MS-16 in children and adults with CF
Study Type: Interventional
Intervention Category: Nutritional-GI Therapies
Study Sponsor: DCI
Study Phase: 3
Recruitment Status: Trial Completed
Study Drug(s): Pancrecarb MS-16
Number of Participants Being Recruited: 20
Single / Multi-Center: Multi-Center
STUDY BACKGROUND INFORMATION:
Pancreatic insufficiency (PI) is a common condition that occurs in approximately 90% of people with cystic fibrosis (CF). Consequently, maldigestion occurs and a variety of essential nutrients are lost through the stools, especially fat and fat soluble vitamins. As a result, patients often experience growth failure and malnutrition. Efficient fat digestion is important in CF because it may lead to improved nutritional and pulmonary status and ultimately to improved quality of life and enhanced survival. This study was designed in accordance with FDA 2006 guideline on exocrine pancreatic insufficiency drug products. The study consisted of two treatment periods with 72-hour stool collections separated by a washout period. Study subjects were required to consume a diet high in fat content.
ELIGIBILITY
Age: >= 7 Years
FEV1: Not Applicable
P. aeruginosa status: Not applicable
B. cepacia status: Not applicable
Other Primary Eligibility Requirements:

Note: Detailed eligibility criteria information may be available on clinicaltrials.gov. If a specific trial listing for this trial is available, a link to the specific clinicaltrials.gov listing will be present in the "More Information" section below.
FOR MORE INFORMATION:
Sponsor Contact Information:
Trial Specific Link on ClinicalTrials.gov: http://www.clinicaltrials.gov/ct2/show/NCT00432861?term=cystic+fibrosis&rank=44
Clinical Research Terms Glossary: Click here
TRIAL RESULTS:
Primary Efficacy:

Twenty-four patients were randomized in this cross-over study comparing a treatment period with Pancrecarb MS-16 to a treatment period where they received placebo. The percent coefficient of fat absorption (CFA) for Pancrecarb MS-16 treated patients was 82.5 compared with 46.3 for placebo (P<0.001). The percent coefficient of nitrogen absorption (CNA) was 79.0 for Pancrecarb treated patients compared with 47.2 for placebo (P<0.001).

Secondary Efficacy:

Stool weight was 49.1% less with Pancrecarb MS-16 compared with placebo.

Safety:

The most commonly reported adverse events for both Pancrecarb MS-16 and placebo were abdominal pain and upper abdominal pain, with fewer subjects reporting gastrointestinal AEs during Pancrecarb MS-16 treatment than during placebo.

The summary of data provided here is from an abstract presented at the Cystic Fibrosis Foundation North American CF Conference (2008). These data may be preliminary and have not been peer-reviewed.

Citation:

Not Available
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