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

Phase 1

Terminated

• Conditions: Chronic Pancreatitis
• Interventions: Drug: EUR-1066-B; Drug: EUR-1066-A; Drug: Zenpep

• Registration Number: NCT01159119
• Lead Sponsor: Forest Laboratories

Brief 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.

Study Timeline

• Study First Submitted: 2010-07-05
• Study First Submitted QC: 2010-07-07
• Study First Posted: 2010-07-09
• Study Start: 2010-08-02
• Primary Completion: 2011-07-01
• Study Completion: 2011-07-01
• Status Verified: 2019-12
• Last Update Submitted: 2020-01-13
• Last Update Posted: 2020-01-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• Diagnosis of Chronic Pancreatitis
• Exocrine Pancreatic Insufficiency
• Chronic abdominal pain

Exclusion Criteria

• Acute pancreatitis
• Active alcohol consumption
• Uncontrolled diabetes

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
EUR-1066-B	EUR-1066-B	Treatment with Eur-1066-B
EUR-1066-A	EUR-1066-A	Treatment with Eur-1006-A.
Zenpep	Zenpep	Control Group: Consist of treatment with Zenpep

Primary Outcome Measures

Name	Time	Method
Comparing frequency and severity of pain	up to 84 days	Patient diary

Secondary Outcome Measures

Name	Time	Method
Changes in fat malabsorption	up to 124 days	Assess the coefficient of fat absorption

Trial Locations

Locations (1)

University of Florida; 🇺🇸 Gainesville, Florida, United States