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

Forest Laboratories

Status and phase: Terminated; Phase 1

Conditions: Chronic Pancreatitis

Treatments: Drug: EUR-1066-A; Drug: Zenpep; Drug: EUR-1066-B

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01159119

PR-012

Details and patient eligibility

About

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

Full description

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

Enrollment: 15 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Acute pancreatitis
• Active alcohol consumption
• Uncontrolled diabetes

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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15 participants in 3 patient groups

EUR-1066-A

Experimental group

Description:

Treatment with Eur-1006-A.

Treatment:

Drug: EUR-1066-A

EUR-1066-B

Experimental group

Description:

Treatment with Eur-1066-B

Treatment:

Drug: EUR-1066-B

Zenpep

Active Comparator group

Description:

Control Group: Consist of treatment with Zenpep

Treatment:

Drug: Zenpep