CLINICAL TRIALS PROFILE FOR ZENPEP
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All Clinical Trials for ZENPEP
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00788593 ↗ | A Randomized, Double-Blind, Dose Response-Control, Crossover Study to Evaluate the Safety and Efficacy of Two Doses of EUR-1008 (APT-1008) in Chronic Pancreatitis (CP) Participants With Exocrine Pancreatic Insufficiency (EPI) | Completed | Forest Laboratories | Phase 3 | 2008-01-01 | The primary efficacy objective of this study is to evaluate the difference in coefficient of fat absorption (CFA) of participants treated with high dose EUR-1008 (APT-1008) versus low dose of EUR-1008 (APT-1008) in the treatment of signs and symptoms of malabsorption in participants with EPI associated with CP. This study is sponsored by Aptalis Pharma (formerly Eurand). |
| NCT01100606 ↗ | A Study to Evaluate the Mode of Administration and Safety of EUR-1008 (APT-1008) in Infants 1 to 12 Months of Age | Completed | Forest Laboratories | Phase 4 | 2010-06-01 | A study to determine the safety, effectiveness, and acceptability of 2 methods of administration of EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsule) 3,000 lipase units capsule, a pancreatic enzyme product (PEP), in infants with exocrine pancreatic insufficiency (EPI) due to cystic fibrosis (CF). This study is sponsored by Aptalis Pharma (formerly Eurand). |
| NCT01131507 ↗ | PR-018: An Open-Label, Safety Extension of Study PR-011 | Completed | Forest Laboratories | Phase 4 | 2010-07-01 | A study to evaluate long term safety and effect on ability to thrive of EUR-1008 (APT-1008) 3,000 lipase units (Zenpep® [pancrelipase] delayed release capsules) in infants with exocrine pancreatic insufficiency (EPI) due to cystic fibrosis (CF). |
| NCT01159119 ↗ | A Study of EUR-1066 in Subjects With Chronic Pancreatitis, Exocrine Pancreatic Insufficiency and Chronic Abdominal Pain | Terminated | University of Florida | Phase 1 | 2010-08-02 | The purpose of this study is to evaluate two different treatments in subjects with chronic pancreatitis, exocrine pancreatic insufficiency and chronic abdominal pain. |
| NCT01159119 ↗ | A Study of EUR-1066 in Subjects With Chronic Pancreatitis, Exocrine Pancreatic Insufficiency and Chronic Abdominal Pain | Terminated | Eurand Pharmaceuticals | Phase 1 | 2010-08-02 | The purpose of this study is to evaluate two different treatments in subjects with chronic pancreatitis, exocrine pancreatic insufficiency and chronic abdominal pain. |
| NCT01159119 ↗ | A Study of EUR-1066 in Subjects With Chronic Pancreatitis, Exocrine Pancreatic Insufficiency and Chronic Abdominal Pain | Terminated | Forest Laboratories | Phase 1 | 2010-08-02 | The purpose of this study is to evaluate two different treatments in subjects with chronic pancreatitis, exocrine pancreatic insufficiency and chronic abdominal pain. |
| NCT01641393 ↗ | Safety and Efficacy Study of 2 Pancreatic Enzymes for Treatment of Exocrine Pancreatic Insufficiency in Cystic Fibrosis. | Completed | Forest Laboratories | Phase 3 | 2012-06-01 | The purpose of the study is to further evaluate the safety and efficacy of EUR-1008 as compared to Kreon® in the treatment of exocrine pancreatic insufficiency associated with Cystic Fibrosis in subjects 12 years of age and older. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
Clinical Trial Conditions for ZENPEP
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