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Last Updated: November 27, 2022

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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Zenpep

Condition Name

Condition Name for Zenpep
Intervention Trials
Cystic Fibrosis 3
Exocrine Pancreatic Insufficiency 3
Chronic Pancreatitis 2
Exocrine Pancreatic Insufficiency: Cystic Fibrosis 1
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Condition MeSH

Condition MeSH for Zenpep
Intervention Trials
Exocrine Pancreatic Insufficiency 5
Cystic Fibrosis 4
Fibrosis 4
Pancreatitis, Chronic 2
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Clinical Trial Locations for Zenpep

Trials by Country

Trials by Country for Zenpep
Location Trials
United States 20
Italy 5
Ukraine 4
Bulgaria 1
Poland 1
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Trials by US State

Trials by US State for Zenpep
Location Trials
Florida 4
Texas 2
Pennsylvania 2
Ohio 2
Nevada 2
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Clinical Trial Progress for Zenpep

Clinical Trial Phase

Clinical Trial Phase for Zenpep
Clinical Trial Phase Trials
Phase 4 2
Phase 3 2
Phase 2 1
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Clinical Trial Status

Clinical Trial Status for Zenpep
Clinical Trial Phase Trials
Completed 5
Terminated 2
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Clinical Trial Sponsors for Zenpep

Sponsor Name

Sponsor Name for Zenpep
Sponsor Trials
Forest Laboratories 5
University of Colorado, Denver 1
Allergan 1
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Sponsor Type

Sponsor Type for Zenpep
Sponsor Trials
Industry 7
Other 6
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