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

NCT ID: NCT01159119

Last Updated: 2020-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-02

Study Completion Date

2011-07-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Pancreatitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

EUR-1066-A

Treatment with Eur-1006-A.

Group Type EXPERIMENTAL

EUR-1066-A

Intervention Type DRUG

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

EUR-1066-B

Treatment with Eur-1066-B

Group Type EXPERIMENTAL

EUR-1066-B

Intervention Type DRUG

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

Zenpep

Control Group: Consist of treatment with Zenpep

Group Type ACTIVE_COMPARATOR

Zenpep

Intervention Type DRUG

Capsules taken for daily for 28 days during treatment period 2

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

EUR-1066-A

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

Intervention Type DRUG

Zenpep

Capsules taken for daily for 28 days during treatment period 2

Intervention Type DRUG

EUR-1066-B

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

EUR-1066 EUR-1066

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* Acute pancreatitis
* Active alcohol consumption
* Uncontrolled diabetes
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Florida

OTHER

Sponsor Role collaborator

Forest Laboratories

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Phillip Toskes, MD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Florida

Gainesville, Florida, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PR-012

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Imaging Biomarkers of Pancreatic Function and Disease
NCT05659147 ENROLLING_BY_INVITATION PHASE4