A multicenter, randomized, parallel-group, placebo-controlled, double-blind study
of 50 patients, ages 24 to 70 years, with EPI due to chronic pancreatitis or pancreatectomy.
Eighteen patients had a history of pancreatectomy (11 were treated with VIOKACE).
After a wash-out period (6-7 days), patients were randomized to a fixed dose of
VIOKACE, 22 tablets per day (6 tablets with 3 meals and 2 tablets with 2 of 3 snacks)
or placebo, in combination with a proton pump inhibitor. Duration of exposure ranged
from 6 to 7 days. All patients were maintained on a controlled high-fat diet of
100 grams of fat per day. Forty-nine patients completed the double-blind treatment
period. The CFA was determined by a 72-hour stool collection during both treatments,
when both fat excretion and fat ingestion were measured. The wash-out period mean
CFA was 48% in the VIOKACE treatment group and 57% in the placebo group.1