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
A Study to Compare US Marketed Creon Manufactured With a Modernized Process at an Alternate Manufacturing Site and Manufactured With the Approved Manufacturing Process at an Alternate Active Pharmaceutical Ingredient Site, in Participants With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis
- First Posted Date
- 2019-04-23
- Last Posted Date
- 2023-09-28
- Lead Sponsor
- AbbVie
- Target Recruit Count
- 36
- Registration Number
- NCT03924947
- Locations
- 🇺🇸
Virginia Commonwealth University Medical Center Main Hospital /ID# 164574, Richmond, Virginia, United States
🇺🇸Nationwide Children's Hospital /ID# 225628, Columbus, Ohio, United States
🇺🇸University of Iowa Hospitals and Clinics /ID# 164551, Iowa City, Iowa, United States
A Study of Creon (Pancrelipase) in Resected and Non-resected Pancreatic Cancer Participants With Exocrine Pancreatic Insufficiency (EPI)
- Conditions
- Exocrine Pancreatic Insufficiency (EPI)
- Interventions
- Drug: Placebo
- First Posted Date
- 2019-03-01
- Last Posted Date
- 2023-06-05
- Lead Sponsor
- AbbVie
- Target Recruit Count
- 1
- Registration Number
- NCT03859869
- Locations
- 🇺🇸
Fox Chase Cancer Center /ID# 202288, Philadelphia, Pennsylvania, United States
🇺🇸NorthShore University HealthSystem /ID# 209026, Evanston, Illinois, United States
🇺🇸East Carolina University /ID# 206661, Greenville, North Carolina, United States
Study of Pancreatic Enzyme Replacement on Completion of Adjuvant Chemotherapy for Resected Pancreatic Adenocarcinoma
- First Posted Date
- 2018-03-19
- Last Posted Date
- 2020-08-03
- Lead Sponsor
- Dana-Farber Cancer Institute
- Target Recruit Count
- 4
- Registration Number
- NCT03469258
- Locations
- 🇺🇸
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
Equivalence Study to Compare Two Strengths of Creon in China
- First Posted Date
- 2018-03-01
- Last Posted Date
- 2021-11-24
- Lead Sponsor
- Abbott
- Target Recruit Count
- 60
- Registration Number
- NCT03450772
- Locations
- 🇨🇳
Shanghai Changhai Hospital, Shanghai, China
PERT for Treatment of Exocrine Pancreatic Insufficiency in Patients With Unresectable Pancreatic Cancer
- Conditions
- Pancreatic InsufficiencyPancreatic CancerPancreatic Enzyme Abnormality
- Interventions
- Drug: Placebo Oral Capsule
- First Posted Date
- 2016-12-07
- Last Posted Date
- 2021-03-15
- Lead Sponsor
- Massimo Raimondo, M.D.
- Target Recruit Count
- 16
- Registration Number
- NCT02985801
- Locations
- 🇺🇸
Mayo Clinic, Jacksonville, Florida, United States
CREON for the Treatment of Post-RYGB Hypoglycemia
- First Posted Date
- 2016-04-12
- Last Posted Date
- 2023-10-26
- Lead Sponsor
- East Carolina University
- Target Recruit Count
- 5
- Registration Number
- NCT02733848
Trial of Pancreatic Enzyme Supplements (Pancrelipase) for Treating Pain in Patients With Chronic Pancreatitis
- First Posted Date
- 2016-03-11
- Last Posted Date
- 2018-02-27
- Lead Sponsor
- Dartmouth-Hitchcock Medical Center
- Registration Number
- NCT02706236
- Locations
- 🇺🇸
Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, United States
Pancreatic Enzyme Supplementation for Celiac Disease
- First Posted Date
- 2015-06-18
- Last Posted Date
- 2021-05-12
- Lead Sponsor
- Beth Israel Deaconess Medical Center
- Target Recruit Count
- 21
- Registration Number
- NCT02475369
- Locations
- 🇺🇸
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
Efficacy and Safety Study of Creon IR in Subjects With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis
- Conditions
- Exocrine Pancreatic Insufficiency in Subjects With Cystic Fibrosis
- Interventions
- First Posted Date
- 2015-04-14
- Last Posted Date
- 2016-04-04
- Lead Sponsor
- Abbott
- Target Recruit Count
- 70
- Registration Number
- NCT02415959
- Locations
- 🇨🇿
Dětská nemocnice FN Brno, Centrum pro cystickou fibrozu, Brno, Czech Republic
🇨🇿Klinika nemocí plicních a TBC, Brno, Czech Republic
🇭🇺Magyar Imre Kórház, Ajka, Hungary
Improving Treatment of Nontuberculous Mycobacterial Infection in Cystic Fibrosis
- Conditions
- Cystic Fibrosis
- Interventions
- First Posted Date
- 2015-02-26
- Last Posted Date
- 2021-02-11
- Lead Sponsor
- University of Colorado, Denver
- Target Recruit Count
- 31
- Registration Number
- NCT02372383
- Locations
- 🇺🇸
Children's Hospital Colroado, Aurora, Colorado, United States
Drug Development Updates
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