Ultrase MT (Lipase / Amylase / Protease) - Summary

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

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NEWS HIGHLIGHTS

Published Studies Related to Ultrase MT (Lipase / Amylase / Protease)

Comparison of a high lipase pancreatic enzyme extract with a regular pancreatin preparation in adult cystic fibrosis patients. [1994.12]
BACKGROUND: Malabsorption due to exocrine pancreatic insufficiency is the main gastrointestinal problem in cystic fibrosis. Despite high doses of pancreatic enzyme supplements it is often not possible to normalize fat absorption. We compared a new high lipase pancreatic enzyme preparation (Pancrease-HL; Cilag, Brussels, Belgium), containing enteric coated microspheres with 25,000 U of lipase, 22,500 U of amylase and 1250 U of protease per capsule, with regular Pancrease capsules, containing 5000 U of lipase, 2900 U of amylase and 330 U of protease per capsule... CONCLUSIONS: One capsule of Pancrease-HL appears to be equivalent to four capsules of regular Pancrease. Treatment with less capsules per day with the same efficacy may facilitate patient compliance.

A double blind lipase for lipase comparison of a high lipase and standard pancreatic enzyme preparation in cystic fibrosis. [1993.02]
A standard acid resistant microsphere pancreatic enzyme preparation was compared with identical capsules half filled with mini-tablets of a new high lipase preparation in a randomised double blind crossover study in children with cystic fibrosis... It is concluded that half filled capsules of the new high lipase preparation are more effective than the standard preparation and it is likely that filled capsules would allow patients to use fewer than half the number of pancreatic enzyme capsules.

Ultrase and Viracept. [1999.10]
AIDS: The Community Research Initiative on AIDS (CRIA) is currently conducting a study to determine the effects of Ultrase MT-20, a digestive supplement, on preventing diarrhea caused by the protease inhibitor Viracept (Nelfinavir). Additional studies have evaluated possible drug interactions between Ultrase and Viracept.

Increase in pancreatic lipase and trypsin activity and their mRNA levels in streptozotocin-induced diabetic rats. [1989.08]
The pancreatic lipase and trypsin activities in streptozotocin-induced diabetic rats were determined as well as the relative levels of mRNA coding for these proteins. It was found that after development of diabetes, the activities of pancreatic lipase and trypsin were significantly increased by 105% and 52%, respectively, accompanied by an increase in the levels of lipase and trypsinogen mRNA by 98% and 49%, respectively, while amylase activity and its mRNA were significantly decreased.

Diagnostic value of immunoreactive phospholipase A2 in acute pancreatitis. [1989.02.01]
In a prospective clinical trial 85 patients with acute pancreatitis were analysed for serum total amylase, pancreatic amylase, pancreatic lipase, trypsin, elastase 1, and immunoreactive phospholipase A2 (IR-PLA2). The diagnostic sensitivity of serum IR-PLA2 was comparable to that of serum total amylase, pancreatic amylase, and trypsin.

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Clinical Trials Related to Ultrase MT (Lipase / Amylase / Protease)

Assessment of Insulin Production From Native Pancreas in Patients With Pancreas Transplants [Completed]
This study will examine whether insulin-producing cells in the pancreas (beta cells) can recover in patients with type 1 diabetes who have had a pancreas transplant. In type 1 diabetes, the body's immune system destroys the beta cells. Patients are treated with insulin shots or a pancreas transplant to control their blood sugar. Some experiments suggest that the pancreas may have the capacity to recover some of its insulin-producing capacity, but that ability is negated by factors such as the continuing immune attack and erratic blood sugar levels in patients.

Patients who have had a pancreas transplant may be in a unique situation to allow their own pancreas to regrow beta cells for two reasons: 1) the medicines they take to prevent rejection of the transplanted pancreas weaken their immune system; and 2) they have near-normal blood sugar levels because of their functioning transplanted pancreas. This study will test this hypothesis by sampling blood from patients' hepatic vein, which drains the liver and native pancreas and from their iliac vein, which drains the transplanted pancreas. This will determine whether insulin is coming from the transplanted pancreas (iliac vein) or the liver and native pancreas (hepatic vein).

Patients 18 years of age and older who have had stable pancreatic transplant function for more than 5 years may be eligible for this study. Candidates are screened with a medical history and physical examination.

Participants are admitted to the hospital for 2 days for a full medical examination, blood tests and procedures to determine insulin production. The procedures will include the placement of catheters in the neck and groin for blood sampling. Participants will be closely monitored after the procedures and discharged home if there are no complications.

Efficacy and Safety of ULTRASE MT20 in Improving the Coefficient of Fat Absorption (CFA%) in Children With Cystic Fibrosis (CF) and Pancreatic Insufficiency (PI) [Completed]
This protocol will enroll children aged 7 to 11 years old, suffering from Cystic Fibrosis and Pancreatic Insufficiency in order to demonstrate the safety of Ultrase MT20 as well as the efficacy of this product in the improvement of the fat absorption.

A Safety and Efficacy Study on ULTRASE MT20 in Patients With Cystic Fibrosis (CF) and Exocrine Pancreatic Insufficiency (PI) [Completed]
Cystic Fibrosis (CF) is a genetic disease resulting from the inheritance of a defective autosomal recessive gene. It often results in exocrine pancreatic insufficiency (PI) that leads to non-digestion of fats and proteins and finally to malabsorption of these nutrients. The patients need to take pancreatic enzymes to allow absorption of these nutriments and this has contributed to a significant increase in the life span of CF patients.

The purpose of this study is to assess the safety and efficacy of ULTRASE MT20 compared to placebo for the correction of fat and protein malabsorption in patients with CF and PI.

Two-Layer Method Preservation and Resuscitation of the Cadaveric Pancreas Before Transplantation [Enrolling by invitation]
The purpose of this project is to compare the effect of oxygenated preservation of the pancreas before transplantation using the "Two-Layer Method" (TLM) against outcomes previously experienced with organs preserved using only standard University of Wisconsin (UW) storage solution. It is our hypothesis that TLM preservation will reduce the frequency and severity of complications of pancreas transplantation, increase the number of organs acceptable for transplantation, and spare individual patients and their families suffering and hardship.

An Effectiveness, Safety, and Palatability Study of Pancrelipase Microtablets in Infants and Toddlers With Cystic Fibrosis and Fat Malabsorption [Completed]
The purpose of this study is to evaluate the effectiveness and safety of PANCREASE MT (pancrelipase microtablets) to improve steatorrhea (excessive excretion of fat in feces) in infants and toddlers with cystic fibrosis who have pancreatic insufficiency, and to assess whether the consistency of the microtablets is acceptable for swallowing in infants and toddlers

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