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

Clinical Trials

A Double-blind, Randomized, Multicenter, Cross-over Study to Compare the Effect of Creon N and Creon® on Fat Digestion in Subjects ≥ 12 Years of Age With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis

Phase 3

Completed

Conditions: Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis

Interventions: Drug: Creon N
Drug: Creon®

First Posted Date: 2014-05-13

Last Posted Date: 2016-01-22

Lead Sponsor: Abbott

Target Recruit Count: 41

Registration Number: NCT02137382

Locations: 🇭🇺
Research facility ID ORG-000825, Törökbálint, Hungary
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Research facility ID ORG-000816, Debrecen, Hungary
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Research facility ID ORG-000826, Budapest, Hungary

and more 4 locations

A Study to Assess the Effect of Creon® on Pancreatic Exocrine Insufficiency in Subjects With Diabetes Mellitus Type 2

Phase 4

Withdrawn

Conditions: Exocrine Pancreatic Insufficiency in Subjects With Diabetes Mellitus Type 2

Interventions: Drug: Creon 25000 matching Placebo
Drug: Creon

First Posted Date: 2013-12-12

Last Posted Date: 2014-06-20

Lead Sponsor: Abbott

Registration Number: NCT02009410

Locations: 🇪🇸
Site reference no. 112520, Málaga, Spain
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Site reference no. 113475, Ulm, Germany
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Site reference no. 113456, Bochum, Germany

and more 7 locations

Creon Use in Coeliac Patients With Low Faecal Pancreatic Elastase

Phase 4

Terminated

Conditions: Patients With Pancreatic Exocrine Insufficiency
Patients With Coeliac Disease and Chronic Diarrhoea (>3 Loose/ Liquid Motions a Day for More Than 4 Weeks)

Interventions: Other: Placebo
Drug: Creon

First Posted Date: 2013-05-31

Last Posted Date: 2019-09-23

Lead Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust

Target Recruit Count: 2

Registration Number: NCT01865695

Locations: 🇬🇧
Department of Gastroenterology, Sheffield, South Yorkshire, United Kingdom

Evaluation of Safety and Tolerability of Creon Micro in Children Younger Than Four Years With Pancreatic Exocrine Insufficiency

Phase 3

Completed

Conditions: Pancreatic Exocrine Insufficiency

Interventions: Drug: Pancreatin

First Posted Date: 2012-12-11

Last Posted Date: 2014-07-15

Lead Sponsor: Abbott Products

Target Recruit Count: 40

Registration Number: NCT01747330

Locations: 🇷🇺
Site Reference ID/Investigator# 80715, Orenburg, Russian Federation
🇷🇺
Site Reference ID/Investigator# 80716, Barnaul, Russian Federation
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Site Reference ID/Investigator# 80698, Novosibirsk, Russian Federation

and more 6 locations

Irritable Bowel Syndrome Evaluation and Treatment in Primary Care

Phase 4

Completed

Conditions: Irritable Bowel Syndrome

Interventions: Drug: Placebo
Drug: Bifidobacterium infantis
Drug: Pancrelipase
Drug: Nitazoxanide

First Posted Date: 2012-07-16

Last Posted Date: 2019-01-23

Lead Sponsor: American Academy of Family Physicians

Target Recruit Count: 61

Registration Number: NCT01641341

Locations: 🇺🇸
Baton Rouge Family Practice, Baton Rouge, Louisiana, United States
🇺🇸
American Academy of Family Physicians-National Research Network, Leawood, Kansas, United States
🇺🇸
Torrance Clinical Research, Lomita, California, United States

and more 6 locations

Special Investigation of LipaCreon on Long-term Use in Patients With Pancreatic Exocrine Insufficiency

Completed

Conditions: Exocrine Pancreatic Insufficiency
Pancreatic Diseases
Digestive System Diseases

Interventions: Drug: Lipacreon

First Posted Date: 2011-09-02

Last Posted Date: 2022-06-13

Lead Sponsor: Mylan Inc.

Target Recruit Count: 579

Registration Number: NCT01427725

Locations: 🇯🇵
Research facility ID ORG-000216, Aichi, Japan
🇯🇵
Research facility ID ORG-000215, Aichi, Japan
🇯🇵
Research facility ORG-000096, Aichi, Japan

and more 186 locations

Special Investigation (All Cases) of LipaCreon in Patients With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis

Completed

Conditions: Cystic Fibrosis
Pancreatic Diseases
Exocrine Pancreatic Insufficiency
Digestive System Diseases

Interventions: Drug: Pancrelipase

First Posted Date: 2011-09-02

Last Posted Date: 2022-06-10

Lead Sponsor: Mylan Inc.

Target Recruit Count: 24

Registration Number: NCT01427712

Locations: 🇯🇵
Site reference ID/Investigator # 96698, Aichi, Japan
🇯🇵
Research facility ORG-000972, Ehime, Japan
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Site Reference ID/Investigator# 65530, Kagawa, Japan

and more 18 locations

Effect of Enzyme Therapy on Protein Metabolism in Chronic Pancreatitis

Not Applicable

Completed

Conditions: Pancreatitis

Interventions: Drug: Creon
Other: No enzyme therapy

First Posted Date: 2010-07-01

Last Posted Date: 2010-07-01

Lead Sponsor: Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement

Target Recruit Count: 11

Registration Number: NCT01154608

Locations: 🇫🇷
Centre de Recherche sur Volontaires, Bobigny, France

Evaluation of the Digestive and Metabolic Utilisation of Dietary Protein in Patients With Chronic Pancreatitis

Phase 4

Completed

Conditions: Chronic Pancreatitis

First Posted Date: 2009-08-12

Last Posted Date: 2009-08-12

Lead Sponsor: Hospital Avicenne

Target Recruit Count: 12

Registration Number: NCT00957151

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

Phase 3

Completed

Conditions: Cystic Fibrosis
Pancreatic Exocrine Insufficiency

Interventions: Drug: Pancrelipase Delayed Release

First Posted Date: 2008-10-20

Last Posted Date: 2010-11-07

Lead Sponsor: Solvay Pharmaceuticals

Target Recruit Count: 19

Registration Number: NCT00775528

Locations: 🇺🇸
Site 9, Boston, Massachusetts, United States
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Site 5, Louisville, Kentucky, United States
🇺🇸
Site 12, Detroit, Michigan, United States

and more 9 locations

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