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.
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
