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Creon (Amylase / Lipase / Protease) - Summary



CREON is a pancreatic enzyme preparation consisting of pancrelipase, an extract derived from porcine pancreatic glands. Pancrelipase contains multiple enzyme classes, including porcine-derived lipases, proteases, and amylases. Pancrelipase is a beige-white amorphous powder. It is miscible in water and practically insoluble or insoluble in alcohol and ether. Each delayed-release capsule for oral administration contains enteric-coated spheres (0.71–1.60 mm in diameter). The active ingredient evaluated in clinical trials is lipase. CREON is dosed by lipase units. Other active ingredients include protease and amylase.

CREON (pancrelipase) is indicated for the treatment of exocrine pancreatic insufficiency due to cystic fibrosis, chronic pancreatitis, pancreatectomy, or other conditions. ®

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

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 safety of Creon 24,000 in subjects with exocrine pancreatic insufficiency due to cystic fibrosis. [2009.12]
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 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)...

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Clinical Trials Related to Creon (Amylase / Lipase / Protease)

Creon Use in Coeliac Patients With Low Faecal Pancreatic Elastase [Terminated]
Faecal elastase is an enzyme test used to identify the presence of pancreatic exocrine insufficiency. This condition manifests with symptoms of diarrhea, weight loss, causing potential impairment on an individual's quality of life. Creon, a pancreatic enzyme supplement, marketed by Abbott Laboratories, Inc. is currently the standard treatment for this condition. However, there has been limited work evaluating the merits of this medication in this condition. This study aims to evaluate the benefits that Creon may have in coeliac patients with low faecal pancreatic elastase by randomising patients with low faecal pancreatic elastase (<200 ug/g) to either treatment with Creon or placebo. Outcome measures that we aim to assess to determine the benefits of Creon include evaluation of stool frequency, abdominal pain, body mass index (BMI) and quality of life.

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.

Efficacy and Safety Study of Creon IR in Subjects With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis [Completed]
The objective of this study is to assess the efficacy and safety of different doses of Creon Immediate Release (IR) in comparison to Creon® 25,000 Delayed Release/Gastro-Resistant (DR/GR) in subjects with Pancreatic Exocrine Insufficiency (PEI) due to Cystis Fibrosis (CF).

Evaluation of Safety and Tolerability of Creon Micro in Children Younger Than Four Years With Pancreatic Exocrine Insufficiency [Completed]
The purpose of this study is to evaluate the safety and tolerability of Creon micro in children younger than four years with pancreatic exocrine insufficiency.

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Reports of Suspected Creon (Amylase / Lipase / Protease) Side Effects

Flatulence (26)Diarrhoea (25)Abdominal Pain (23)Weight Decreased (18)Drug Ineffective (15)Nausea (15)Dizziness (12)Abdominal Distension (12)Vomiting (12)Constipation (10)more >>

Page last updated: 2011-12-09

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