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

Primary Purpose

Chronic Pancreatitis

Status

Terminated

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

EUR-1066-A

Zenpep

EUR-1066-B

About this trial

This is an interventional treatment trial for Chronic Pancreatitis focused on measuring Chronic Abdominal Pain, Exocrine Pancreatic Insufficiency

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Diagnosis of Chronic Pancreatitis
Exocrine Pancreatic Insufficiency
Chronic abdominal pain

Exclusion Criteria:

Acute pancreatitis
Active alcohol consumption
Uncontrolled diabetes

Sites / Locations

University of Florida

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

EUR-1066-A

EUR-1066-B

Zenpep

Arm Description

Treatment with Eur-1006-A.

Treatment with Eur-1066-B

Control Group: Consist of treatment with Zenpep

Outcomes

Primary Outcome Measures

Comparing frequency and severity of pain

Patient diary

Secondary Outcome Measures

Changes in fat malabsorption

Assess the coefficient of fat absorption

Full Information

NCT ID

NCT01159119

First Posted

July 5, 2010

Last Updated

January 13, 2020

Sponsor

Forest Laboratories

Collaborators

University of Florida

1. Study Identification

Unique Protocol Identification Number

NCT01159119

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2019

Overall Recruitment Status

Terminated

Study Start Date

August 2, 2010 (Actual)

Primary Completion Date

July 1, 2011 (Actual)

Study Completion Date

July 1, 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Forest Laboratories

Collaborators

University of Florida

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Pancreatitis

Keywords

Chronic Abdominal Pain, Exocrine Pancreatic Insufficiency

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare Provider

Allocation

Randomized

Enrollment

15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

EUR-1066-A

Arm Type

Experimental

Arm Description

Treatment with Eur-1006-A.

Arm Title

EUR-1066-B

Arm Type

Experimental

Arm Description

Treatment with Eur-1066-B

Arm Title

Zenpep

Arm Type

Active Comparator

Arm Description

Control Group: Consist of treatment with Zenpep

Intervention Type

Drug

Intervention Name(s)

EUR-1066-A

Other Intervention Name(s)

EUR-1066

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Zenpep

Intervention Description

Capsules taken for daily for 28 days during treatment period 2

Intervention Type

Drug

Intervention Name(s)

EUR-1066-B

Other Intervention Name(s)

EUR-1066

Intervention Description

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

Primary Outcome Measure Information:

Title

Comparing frequency and severity of pain

Description

Patient diary

Time Frame

up to 84 days

Secondary Outcome Measure Information:

Title

Changes in fat malabsorption

Description

Assess the coefficient of fat absorption

Time Frame

up to 124 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Diagnosis of Chronic Pancreatitis Exocrine Pancreatic Insufficiency Chronic abdominal pain Exclusion Criteria: Acute pancreatitis Active alcohol consumption Uncontrolled diabetes

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Phillip Toskes, MD

Organizational Affiliation

University of Florida

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Florida

City

Gainesville

State/Province

Florida

ZIP/Postal Code

32611

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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