ULTRASE MT SUMMARY
ULTRASE® MT (pancrelipase) Capsules are orally administered capsules containing enteric-coated minitablets of porcine pancreatic enzyme concentrate, predominantly pancreatic lipase, amylase, and protease.
ULTRASE® MT (pancrelipase) Capsules are indicated for patients with partial or complete exocrine pancreatic insufficiency caused by:
Cystic fibrosis (CF)
Chronic pancreatitis due to alcohol use or other causes
Surgery (pancreatico-duodenectomy or Whipple's procedure, with or without Wirsung duct injection, total pancreatectomy)
Obstruction (pancreatic and biliary duct lithiasis, pancreatic and duodenal neoplasms, ductal stenosis)
Other pancreatic disease (hereditary, post traumatic and allograft pancreatitis, hemochromatosis, Shwachman's Syndrome, lipomatosis, hyperparathyroidism)
Poor mixing (Billroth II gastrectomy, other types of gastric bypass surgery, gastrinoma)
Pancrelipase capsules are effective in controlling steatorrhea.1-9
Published Studies Related to Ultrase MT (Lipase / Amylase / Protease)
Treatment of infants and toddlers with cystic fibrosis-related pancreatic insufficiency and fat malabsorption with pancrelipase MT. [2011.07]
BACKGROUND: Pancreatic enzyme replacement therapy (PERT) improves nutritional status and growth in patients with cystic fibrosis (CF) with pancreatic insufficiency (PI). The current recommendation for infants and young children, who are not able to swallow the whole capsule, is to open the capsule and mix the beads in a spoon with some applesauce; however, the efficacy and safety data of this approach are currently lacking. The aim of this study was to assess the efficacy, palatability (ease of swallowing), and safety of 4 dose levels of pancrelipase microtablets (Pancrease MT) in infants and young children with CF-related PI... CONCLUSION: Treatment with Pancrease MT at a dosage of 500 U lipase/kg/meal resulted in a CFA of approximately 89% in pediatric subjects ages 6 to 30 months with PI resulting from CF. Pancrease MT doses were well tolerated and mean palatability was scored as fair to good. Present results do not indicate that a dosage higher than 500 U (Ph. EUR) lipase/kg/meal increases the coefficient of fat absorption in a cohort of infants 6 to 30 months of age.
Pancrelipase delayed-release capsules (CREON) for exocrine pancreatic insufficiency due to chronic pancreatitis or pancreatic surgery: A double-blind randomized trial. [2010.10]
OBJECTIVES: Pancreatic-enzyme replacement therapy (PERT) is the standard of care to prevent maldigestion, malnutrition, and excessive weight loss in patients with exocrine pancreatic insufficiency (EPI) due to chronic pancreatitis (CP) or pancreatic surgery (PS). Our objective was to assess the efficacy and safety of a new formulation of pancrelipase (pancreatin) delayed-release 12,000-lipase unit capsules (CREON) in patients with EPI due to CP or PS... CONCLUSIONS: Pancrelipase delayed-release 12,000-lipase unit capsules were effective in treating fat and nitrogen maldigestion with a TEAE rate similar to that of placebo in patients with EPI due to CP or PS.
Pancrelipase Delayed-Release Capsules (CREON) for Exocrine Pancreatic Insufficiency due to Chronic Pancreatitis or Pancreatic Surgery: A Double-Blind Randomized Trial. [2010.05.25]
CONCLUSIONS:Pancrelipase delayed-release 12,000-lipase unit capsules were effective in treating fat and nitrogen maldigestion with a TEAE rate similar to that of placebo in patients with EPI due to CP or PS.Am J Gastroenterol advance online publication, 25 May 2010; doi:10.1038/ajg.2010.201.
Efficacy and tolerability of a new formulation of pancrelipase delayed-release capsules in children aged 7 to 11 years with exocrine pancreatic insufficiency and cystic fibrosis: a multicenter, randomized, double-blind, placebo-controlled, two-period crossover, superiority study. [2010.01]
BACKGROUND: Pancreatic enzyme replacement therapy (PERT) is essential for maintaining adequate nutrition in children with exocrine pancreatic insufficiency (EPI) due to cystic fibrosis (CF). The US Food and Drug Administration regulations now require all PERT products to undergo clinical efficacy and safety studies before they can be considered for marketing approval. OBJECTIVE: This study was conducted to compare the efficacy of a new formulation of pancrelipase (pancreatin) delayed-release 12,000-lipase unit capsules with placebo in children with EPI due to CF... CONCLUSIONS: In this study in children with EPI due to CF, the new formulation of pancrelipase delayedrelease capsules was associated with improvements in CFA, CNA, stool properties, and EPI symptoms compared with placebo. Pancrelipase delayed-release capsules appeared to be well tolerated. ClinicalTrials.gov identifier: NCT00690820. (Clin Ther.
Efficacy and tolerability of a new formulation of pancrelipase delayed-release
capsules in children aged 7 to 11 years with exocrine pancreatic insufficiency
and cystic fibrosis: a multicenter, randomized, double-blind, placebo-controlled,
two-period crossover, superiority study. 
placebo in children with EPI due to CF... CONCLUSIONS: In this study in children with EPI due to CF, the new formulation of
Clinical Trials Related to Ultrase MT (Lipase / Amylase / Protease)
Viokase 16, Viokase16 Plus Nexium and Nexium Alone [Terminated]
Our primary hypothesis is that the addition of Nexium to Viokase 16 will decrease the
chronic abdominal pain in patients with small duct chronic pancreatitis in a superior
fashion compared to Viokase 16 plus placebo or to Nexium alone. A secondary hypothesis would
be an increase in quality of life. Our objective is to elucidate the role of Nexium in the
control of pancreatic pain, quality of life, and narcotic usage alone or when added to
Viokase 16. Our endpoints are the reduction of abdominal pain, decreased pain medication
usage, decreased ER visits and decreased hospital admissions for abdominal pain.
RNA Sequencing of Solid and Cystic Lesions of the Pancreas [Enrolling by invitation]
The nature of cysts and solid masses in the pancreas can be difficult to diagnose. They may
be benign, precancerous, or cancer. Current tests such as cytology (looking under a
microscope) and tumor markers do not always give us the answer. The investigators are
looking for genetic markers on biopsy specimens from the pancreas that will give us a better
test for diagnosis. This study is only for diagnosing these lesions. The investigators are
not treating any patients.
The Summer Camp Study 2:Blood Glucose Control With a Bi-Hormonal Endocrine Pancreas [Active, not recruiting]
This study will test the hypothesis that a wearable automated bionic pancreas system that
automatically delivers both insulin and glucagon can improve glycemic control vs. usual care
for young people with type 1 diabetes ages 6-11 years old in a diabetes camp environment.
Prospective Evaluation of the Resection Margins and the Ganglionic Status Using a Quality Standard Resection for Adenocarcinoma of the Head of the Pancreas [Completed]
This multicentric prospective study evaluates the role of the margins resection and the
ganglionic status when using a quality standard for the resection of adenocarcinoma of the
head of the pancreas.
Histidine-Tryptophane-Ketoglutarate (HTK) vs University of Wisconsin (UW) Perfusion in Clinical Pancreas Transplantation [Completed]
Graft preservation in clinical pancreas transplantation is based on hypothermia achieved by
topic cooling and cold in situ flushing using special perfusion solutions designed to
attenuate the effects of ischemia/reperfusion and prolong cold ischemia tolerance.
For pancreas transplantation, University of Wisconsin (UW) solution is the most commonly
used perfusate. However, over the last years, Histidine-Tryptophan-Ketoglutarate (HTK)
solution has been increasingly used for abdominal organ procurement. Retrospective reports
published so far have demonstrated the safety of both perfusion solutions.
However, to date, no prospective study comparing both perfusion solutions has been
published. Aim of this study was to prospectively evaluate early pancreas graft function in
clinical pancreas transplantation after organ perfusion with HTK vs. UW solution.
The study hypothesis is that HTK is not inferior to UW for organ perfusion during
procurement in clinical pancreas transplantation.
Page last updated: 2013-02-10