Phase 3 Study of the Safety and Effectiveness of ULTRASE MT20 for Pancreatic Insufficiency
Number of Participants Being Recruited:
Single / Multi-Center:
STUDY BACKGROUND INFORMATION:
This study will assess the safety and efficacy of a pancreatic enzyme capsule designed for the absorption of nutrients in patients with CF. Approximately 90 percent of people with CF need to take pancreatic enzymes to help them absorb fat and protein properly. Pancreatic enzyme supplements help CF patients to enhance digestion, improve growth, reduce gastrointestinal problems, and contribute to general nutritional health. In addition, use of pancreatic enzymes has played a significant role in increasing the lifespan of people with CF. In the study, individuals will receive either oral capsules of ULTRASE MT (a porcine pancreatic enzyme) or a placebo. Both groups will consume a specific amount of fat and protein. Resulting amounts of fat and protein absorbed will be measured in both groups to determine the efficacy of the enzyme.
>= 7 Years
P. aeruginosa status:
B. cepacia status:
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.
Thirty-one CF patients (Age >/=7 years) with exocrine pancreatic insufficiency were randomized into this Phase 3 crossover study that compared efficacy and safety of a new formulation of pancrealipase 20,000 IU lipase/capsule (UltraseÂ® MT-20) vs placebo. During two evaluation periods (6-7 days), patients maintained individualized high-fat diets and received pancrealipase at doses established during a stabilization period or placebo and then crossed over to the opposite treatment. MT-20 significantly increased mean CFA% (coefficient of fat absorption) and mean CNA% (coefficient of nitrogen absorption), +34.7% and 25.7%, respectively; p<0.0001 for both.
The pancrealipase also reduced stool frequency and improved stool consistency compare with placebo.
Patients reported more AEs while on placebo (109 vs 33 while on pancrealipase). The most frequently reported AEs were GI and consistent with CF.