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

Chronic Pancreatitis Clinical Trial

— EUR-1066  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01159119
• Other study ID #: PR-012
• Status: Terminated
• Phase: Phase 1
• Start date: August 2, 2010
• Est. completion date: July 1, 2011

Study information

• Verified date: December 2019
• Source: Forest Laboratories
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: July 1, 2011
• Est. primary completion date: July 1, 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of Chronic Pancreatitis

• Exocrine Pancreatic Insufficiency

• Chronic abdominal pain

Exclusion Criteria:

• Acute pancreatitis

• Active alcohol consumption

• Uncontrolled diabetes

Related Conditions & MeSH terms

• Abdominal Pain
• Chronic Pancreatitis
• Exocrine Pancreatic Insufficiency
• Pancreatitis
• Pancreatitis, Chronic

Intervention

Drug:
• EUR-1066-A
Eur-1066 capsules taken daily for 28 days either during treatment period 1 or treatment period 3.
• Zenpep
Capsules taken for daily for 28 days during treatment period 2
• EUR-1066-B
Eur-1066 capsules taken daily for 28 days either during treatment period 1 or treatment period 3.

Locations

Country	Name	City	State
United States	University of Florida	Gainesville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Forest Laboratories	University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparing frequency and severity of pain	Patient diary	up to 84 days
Secondary	Changes in fat malabsorption	Assess the coefficient of fat absorption	up to 124 days