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Study Name: Study of Pancrease MT Capsules in People with CF and Pancreatic Insufficiency
Study Type: Interventional
Intervention Category: Nutritional-GI Therapies
Study Sponsor: Johnson & Johnson
Study Phase: 3
Recruitment Status: Trial Completed
Study Drug(s): Pancrease MT
Number of Participants Being Recruited: 40
Single / Multi-Center: Multi-Center
STUDY BACKGROUND INFORMATION:
This was a randomized, placebo-controlled, double-blind withdrawal, multicenter study to evaluate the effectiveness of pancrelipase MT capsules compared with placebo in the treatment of adult (>18 to 60 years of age) and children/adolescent (7 to <18 years of age) patients with CF and who require pancreatic enzyme replacement therapy (PERT) to control clinical symptoms of EPI and steatorrhea (excess fat in the feces).
ELIGIBILITY
Age: 7 Years - 60 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/NCT00662675?term=pancrelipase+and+cystic+fibrosis&rank=2
Clinical Research Terms Glossary: Click here
TRIAL RESULTS:
Primary Efficacy:

Forty subjects were randomized in this double blind study testing the safety and efficacy of PANCREAZE® (pancrelipase). The mean Coefficient of Fat Absorption (CFA) at the end of the open-label phase compared to the end of the double-blind phase decreased slightly by 1.5% in subjects who continued to received PANCREASE-MT compared with a decrease of 34.1% in those who received placebo.

Secondary Efficacy:

The mean Coefficient of Nitrogen Absorption (CNA) showed similar results to CFA. Patients receiving PANCREASE-MT also had markedly better outcomes on clinical signs and symptoms of EPI, stool consistency, and CGI scores than those who received placebo

Safety:

Adverse events occurred less frequently in the PANCREASE-MT treated group and were primarily gastrointestinal disorders. No unexpected adverse events were reported

Citation:

J Cyst Fibros 2011;10(5):350-356

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