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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

Bioavailability of Pancreatic Enzymes in the Human Upper Intestine (Duodenum and Jejunum)

Not Applicable
Terminated
Conditions
Exocrine Pancreatic Insufficiency
Interventions
Drug: placebo
First Posted Date
2008-09-09
Last Posted Date
2013-02-22
Lead Sponsor
Digestive Care, Inc.
Target Recruit Count
11
Registration Number
NCT00749099

Intraduodenal Aspiration Study to Assess the Bioavailability of Oral Pancrecarb® Compared to Placebo Control

Phase 4
Terminated
Conditions
Exocrine Pancreatic Insufficiency
Chronic Pancreatitis
Cystic Fibrosis
Interventions
First Posted Date
2008-08-29
Last Posted Date
2013-02-22
Lead Sponsor
Digestive Care, Inc.
Target Recruit Count
3
Registration Number
NCT00744250
Locations
🇺🇸

UNC Healthcare, Chapel Hill, North Carolina, United States

Creon 40,000 for Treatment of PEI (Pancreatic Exocrine Insufficiency) Due to Chronic Pancreatitis

Phase 3
Completed
Conditions
Pancreatic Insufficiency
Interventions
Drug: Placebo
First Posted Date
2008-06-27
Last Posted Date
2011-08-18
Lead Sponsor
Abbott Products
Target Recruit Count
62
Registration Number
NCT00705978
Locations
🇮🇳

Site Reference ID/Investigator# 45390, Chennai, India

🇮🇳

Site Reference ID/Investigator# 45391, Hyderabad, India

🇮🇳

Site Reference ID/Investigator# 45395, Pune, India

and more 8 locations

Study Investigating a Delayed-Release Pancrelipase in Patients With Pancreatic Exocrine Insufficiency (PEI) Due to Cystic Fibrosis (CF)

Phase 3
Completed
Conditions
Cystic Fibrosis
Pancreatic Exocrine Insufficiency
Interventions
Drug: Placebo Comparator
First Posted Date
2008-06-05
Last Posted Date
2010-06-02
Lead Sponsor
Solvay Pharmaceuticals
Target Recruit Count
17
Registration Number
NCT00690820
Locations
🇺🇸

Site 10, Oklahoma City, Oklahoma, United States

🇺🇸

Site 2, Iowa City, Iowa, United States

🇺🇸

Site 5, Louisville, Kentucky, United States

and more 7 locations

A Study of the Enzyme Activity and Safety of Pancrelipase in Patients With Severe Exocrine Pancreatic Insufficiency (EPI)

Phase 1
Completed
Conditions
Exocrine Pancreatic Insufficiency
Pancreatitis, Chronic
Steatorrhea
Pancreatitis
Interventions
First Posted Date
2008-05-13
Last Posted Date
2011-05-19
Lead Sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Target Recruit Count
13
Registration Number
NCT00676702

Creon in HIV Patients With Steatorrhea

Phase 3
Terminated
Conditions
Steatorrhea
Interventions
Drug: Placebo
First Posted Date
2008-02-25
Last Posted Date
2011-08-01
Lead Sponsor
Abbott
Target Recruit Count
34
Registration Number
NCT00623025
Locations
🇷🇴

Site Reference ID/Investigator# 59363, Craiova, Romania

🇷🇴

Site Reference ID/Investigator# 59364, Bucharest, Romania

Creon After Pancreatic Surgery

Phase 4
Completed
Conditions
Pancreatic Insufficiency
Interventions
Drug: Placebo
First Posted Date
2007-09-26
Last Posted Date
2011-08-18
Lead Sponsor
Abbott Products
Target Recruit Count
58
Registration Number
NCT00535756
Locations
🇧🇬

Site Reference ID/Investigator# 45020, Sofia, Bulgaria

🇩🇪

Site Reference ID/Investigator# 45024, Munich, Germany

🇮🇹

Site Reference ID/Investigator# 45130, Bologna, Italy

and more 12 locations

Study Investigating a Delayed-Release Pancrelipase in Patients With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis

Phase 3
Completed
Conditions
Cystic Fibrosis
Interventions
Drug: Placebo Comparator
First Posted Date
2007-08-02
Last Posted Date
2010-06-03
Lead Sponsor
Solvay Pharmaceuticals
Target Recruit Count
35
Registration Number
NCT00510484
Locations
🇭🇺

Site 20, Petrofi, Hungary

🇺🇸

Site 7, Louisville, Kentucky, United States

🇺🇸

Site 12, Dayton, Ohio, United States

and more 20 locations

A Study to Investigate the Effect of Delayed Release Pancrelipase on Maldigestion in Patients With Exocrine Pancreatic Insufficiency Due to Chronic Pancreatitis and Pancreatectomy

Phase 3
Completed
Conditions
Chronic Pancreatitis
Pancreatectomy
Pancreatic Exocrine Insufficiency
Interventions
First Posted Date
2006-12-22
Last Posted Date
2011-08-10
Lead Sponsor
Solvay Pharmaceuticals
Target Recruit Count
52
Registration Number
NCT00414908
Locations
🇺🇸

Site 17, Chicago, Illinois, United States

🇺🇸

Site 30, Maywood, Illinois, United States

🇺🇸

Site 21, Pittsburgh, Pennsylvania, United States

and more 27 locations

Efficacy of Pancrelipase on Postprandial Belching and Bloating.

Phase 3
Completed
Conditions
Postprandial Bloating
Postprandial Belching
Postprandial Eructation
First Posted Date
2005-12-19
Last Posted Date
2005-12-19
Lead Sponsor
Solvay Pharmaceuticals
Target Recruit Count
45
Registration Number
NCT00266721
Locations
🇺🇸

VAMC, Minneapolis, Minnesota, United States

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