NCT01159119

A Study of EUR-1066 in Subjects With Chronic Pancreatitis, Exocrine Pancreatic Insufficiency and Chronic Abdominal Pain

Single Center Randomized Single Blind Crossover Group Active Control Study to Evaluate Safety and Efficacy of EUR-1066 a Pancreatic Enzyme Product in Patients With Chronic Pancreatitis Exocrine Pancratic Insufficiency,Chronic Abdominal Pain

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Forest Laboratories · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate two different treatments in subjects with chronic pancreatitis, exocrine pancreatic insufficiency and chronic abdominal pain.

Detailed description

To evaluate two different preparations of a pancreatic enzyme in subjects with chronic pancreatitis, exocrine pancreatic insufficiency, and chronic abdominal pain.

Conditions

• Chronic Pancreatitis

Interventions

Type	Name	Description
DRUG	EUR-1066-A	Eur-1066 capsules taken daily for 28 days either during treatment period 1 or treatment period 3.
DRUG	Zenpep	Capsules taken for daily for 28 days during treatment period 2
DRUG	EUR-1066-B	Eur-1066 capsules taken daily for 28 days either during treatment period 1 or treatment period 3.

Timeline

• Start date: 2010-08-02
• Primary completion: 2011-07-01
• Completion: 2011-07-01
• First posted: 2010-07-09
• Last updated: 2020-01-18

Locations

1 site across 1 country: United States