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Pancrelipase

Generic Name
Pancrelipase
Drug Type
Biotech
CAS Number
53608-75-6
Unique Ingredient Identifier
FQ3DRG0N5K
Background

Pancrelipase, in general, is composed of a mixture of pancreatic enzymes which include amylases, lipases, and proteases. These enzymes are extracted from porcine pancreatic glands. The pancrelipase mixture was developed by Ortho-McNeil-Janssen Pharmaceuticals, Inc and FDA approved on April 12, 2010. For further information on the components of this mixture please visit Pancrelipase amylase, Pancrelipase protease and Pancrelipase lipase.

Indication

The use of pancrelipase amylase is part of the pancreatic enzyme replacement therapy. This therapy is indicated for the treatment of pancreatic insufficiency attributed to cystic fibrosis, chronic pancreatitis or any other medically defined pancreatic disease that might require it. Pancreatic diseases are associated with the deterioration of pancreatic parenchyma and of the dual physiological functions of the pancreas. Once established, pancreatic insufficiency results in malnutrition, weight loss, and steatorrhea.

Associated Conditions
Aerophagy, Deficiency Digestive enzymes, Diarrhea, Dyspepsia, Exocrine Pancreatic Insufficiency, Flatulence, Gastrointestinal Discomfort, Pancreatic Insufficiency, Post Operative Gas, Pre-operative Gas, Fat malabsorption, Meteorism
Associated Therapies
Bile Duct Disorders, Carbohydrate Digestion, Digestive Aid, Fat Digestion, Liver Metabolism, Protein Digestion

An Effectiveness, Safety, and Palatability Study of Pancrelipase Microtablets in Infants and Toddlers With Cystic Fibrosis and Fat Malabsorption

Phase 2
Completed
Conditions
Cystic Fibrosis
Steatorrhea
First Posted Date
2005-09-22
Last Posted Date
2011-05-19
Lead Sponsor
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
Target Recruit Count
18
Registration Number
NCT00217204

Gastrectomy Study: Study to Investigate the Effect of Creon 25000 Minimicrospheres on Body Mass Index (BMI) in Patients After Gastrectomy

Phase 4
Completed
Conditions
Gastrectomy
Interventions
Drug: Placebo
First Posted Date
2005-09-12
Last Posted Date
2008-03-31
Lead Sponsor
Solvay Pharmaceuticals
Target Recruit Count
40
Registration Number
NCT00160186
Locations
🇸🇪

Site 6, Stockholm, Sweden

🇫🇮

Site 10, Tampere, Finland

🇩🇰

Site 9, Odense, Denmark

and more 6 locations

Randomized Study of Pancrelipase With Bicarbonate (PANCRECARB) Capsules in Reducing Steatorrhea in Patients With Cystic Fibrosis

Not Applicable
Completed
Conditions
Cystic Fibrosis
First Posted Date
2000-07-06
Last Posted Date
2005-06-24
Lead Sponsor
National Center for Research Resources (NCRR)
Target Recruit Count
24
Registration Number
NCT00006063
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