Trial | NCT01159119  Report issue

Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Terminated

  • Study Participants

    15
The purpose of this study is to evaluate two different treatments in subjects with chronic pancreatitis, exocrine pancreatic insufficiency and chronic abdominal pain.
To evaluate two different preparations of a pancreatic enzyme in subjects with chronic pancreatitis, exocrine pancreatic insufficiency, and chronic abdominal pain.
Study Started
Aug 02
2010
Primary Completion
Jul 01
2011
Study Completion
Jul 01
2011
Last Update
Jan 18
2020

Drug EUR-1066-A

Eur-1066 capsules taken daily for 28 days either during treatment period 1 or treatment period 3.

  • Other names: EUR-1066

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.

  • Other names: EUR-1066

EUR-1066-A Experimental

Treatment with Eur-1006-A.

EUR-1066-B Experimental

Treatment with Eur-1066-B

Zenpep Active Comparator

Control Group: Consist of treatment with Zenpep

Criteria 

Inclusion Criteria:

Diagnosis of Chronic Pancreatitis
Exocrine Pancreatic Insufficiency
Chronic abdominal pain

Exclusion Criteria:

Acute pancreatitis
Active alcohol consumption
Uncontrolled diabetes
No Results Posted