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Study Name: Study of delayed released pancrelipase capsules in people with CF and pancreatic insufficiency
Study Type: Interventional
Intervention Category: Nutritional-GI Therapies
Study Sponsor: AbbVie
Study Phase: 3
Recruitment Status: Trial Completed
Study Drug(s): Creon
Number of Participants Being Recruited: 34
Single / Multi-Center: Multi-Center
STUDY BACKGROUND INFORMATION:
This study will assess the effect of pancrelipase delayed release 24,000 unit capsules on fat and nitrogen absorption in people with Cystic Fibrosis and pancreatic insufficiency.
ELIGIBILITY
Age: >= 12 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/NCT00510484?term=pancrelipase+and+cystic+fibrosis&rank=4
Clinical Research Terms Glossary: Click here
TRIAL RESULTS:
Primary Efficacy:

Thirty-two CF patients (Age >/= 12 years) with exocrine pancreatic insufficiency were randomized into this Phase 3 crossover study that compared efficacy and safety of Creon® 24,000-unit capsules vs placebo. Individualized diets, developed prior to study initiation, were maintained during the two 5-day treatment periods in which patients received Creon or placebo and then crossed over to the opposite treatment. Mean CFA (coefficient of fat absorption) was significantly greater with Creon compared with placebo (88.6% vs 49.6%, respectively, p<0.001).

Secondary Efficacy:

Mean CAN (coefficient of nitrogen absorption) was significantly greater with Creon than placebo. Stool fat, stool nitrogen, and stool weight were all significantly lower with Creon treatment compared with placebo.

Safety:

Adverse symptoms occurred less frequently during Creon treatment compared with placebo treatment.

Citation:

J Cyst Fibros 2009;8:370-377

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