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Creon (Amylase / Lipase / Protease) - Summary

 



CREON SUMMARY

CREON® 5 Capsules are orally administered and contain delayed-release MINIMI-CROSPHERES® of pancrelipase, which is of porcine pancreatic origin. Each CREON® 5 Capsule contains lipase 5,000 USP Units, protease 18,750 USP Units and amylase 16,600 USP Units.

CREON® 5 Capsules are indicated for patients with pancreatic exocrine insufficiency as is often associated with:

  • cystic fibrosis
  • chronic pancreatitis
  • post-pancreatectomy
  • post-gastrointestinal bypass surgery (e.g., Billroth II gastroenterostomy)
  • ductal obstruction from neoplasm (e.g.,of the pancreas or common bile duct)


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NEWS HIGHLIGHTS

Media Articles Related to Creon (Amylase / Lipase / Protease)

Results Published In Journal Of Cystic Fibrosis Confirm CREON(R) (pancrelipase) Delayed-Release Capsules Improves Fat Absorption
Source: Cystic Fibrosis News From Medical News Today [2009.10.10]
Solvay Pharmaceuticals, Inc. announced that Phase III data published in the Journal of Cystic Fibrosis showed that CREON® (pancrelipase) Delayed-Release Capsules, the most prescribed pancreatic enzyme replacement therapy (PERT) in the United States, significantly improves a key measure of fat absorption in patients with CF who suffer from exocrine pancreatic insufficiency (EPI).

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Published Studies Related to Creon (Amylase / Lipase / Protease)

The effects of oral pancreatic enzymes (Creon 10 capsule) on steatorrhea: a multicenter, placebo-controlled, parallel group trial in subjects with chronic pancreatitis. [2006.08]
OBJECTIVES: Creon 10 Minimicrospheres is an enteric-coated, delayed-release pancrelipase preparation designed to deliver active pancreatic enzymes to the small intestine. The primary objective of this study was to compare the effect of Creon 10 with placebo in the control of steatorrhea in chronic pancreatitis patients. Secondary objectives included evaluation of stool parameters and global improvement of symptoms scales... CONCLUSIONS: This randomized, placebo-controlled trial found that Creon 10 treatment controlled steatorrhea, as reflected in reduced fat excretion, decreased stool frequency and improved stool consistency. Creon 10 treatment was safe and well tolerated.

Creon 10,000 Minimicrospheres vs. Creon 8,000 microspheres--an open randomised crossover preference study. [2002.12]
Creon 10,000 Minimicrospherestrade mark (Creon) 10,000 MMS) is a pancreatic enzyme formulation that contains smaller spheres of pancreatin in a 50% smaller capsule than conventional microspheres (Creon) 8,000)...

[Comparative clinical study of Neopanpur and Creon] [1994.01.02]
The aim of the study was to compare the clinical efficacy of Neopanpur (EGIS) and Creon (Kalichemie) in patients with chronic pancreatitis. Fifteen patients were examined for 2 x 10 days... Both enzyme preparations can be applied in the treatment of maldigestion in patients with chronic pancreatic insufficiency.

Efficacy and safety of Creon(R) 24,000 in subjects with exocrine pancreatic insufficiency due to cystic fibrosis. [2009.10.06]
BACKGROUND: Pancreatic enzyme replacement therapy is critical for adequate nutrition in cystic fibrosis (CF) patients with exocrine pancreatic insufficiency (EPI)... CONCLUSIONS: This study demonstrated Creon was effective in treating EPI due to CF and was safe and well tolerated.

The enzyme levels in blood are not affected by oral administration of a pancreatic enzyme preparation (Creon 10,000) in pancreas-insufficient pigs. [2004.01]
After oral intake, small amounts of intact protein may be absorbed into the blood circulation. The current study investigated whether orally administered pancreatic enzymes were absorbed from the intestine... The results showed no absorption into blood of pancreatic enzymes after oral administration (0, 2, 4, or 8 g of Creon mixed with 100 g of feed) to pancreas-insufficient pigs.

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Clinical Trials Related to Creon (Amylase / Lipase / 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.

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

Evaluation of the Safety and Efficacy of Pancrecarb® MS-16 in Cystic Fibrosis [Recruiting]
The primary objective of this study is to determine if PANCRECARB® MS-16 (pancrelipase) is safe and effective in reducing steatorrhea (as measured by 72-hour stool fat determinations) in children and adults with cystic fibrosis and pancreatic insufficiency.

An Open-Label, Comparative, Randomized, Prospective Study To Compare Sirolimus Versus Tacrolimus In De Novo Simultaneous Pancreas- Kidney Allograft Recipients Receiving An Induction Therapy With Antithymocyte Globulin Plus Mycophenolate Mofetil Plus Corticosteroids [Recruiting]
Experience with tacrolimus in pancreas transplantation has become a standard for immunosuppression in almost all pancreas centers over the world. Several centers have shown very good results in simultaneous pancreas-kidney (SPK) transplant recipients receiving antithymocyte globulin induction and maintenance immunosuppression consisting of calcineurin inhibitor and mycophenolate mofetil with or without corticosteroids.

The use of sirolimus in SPK transplant patients has for the moment only been studied, with good results, in association with tacrolimus or cyclospsorine (CsA). In renal transplantation, there is also evidence that sirolimus (Rapamune) is a potent immunosuppressant that significantly reduces the incidence of acute rejection when given with CsA, effective as base therapy in the post-induction period. Because of Rapamune's effectiveness and different safety profile, it might be advantageous in terms of reduced nephrotoxicity to avoid completely calcineurin inhibitors without increased incidence of acute rejection.

To explore this further, the following study is designed to assess the use of SRL versus TAC, both treatment groups including rATG plus MMF and a 3-month course of steroids in de novo simultaneous pancreas-kidney transplant recipients.

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Page last updated: 2009-10-20

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