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

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

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01159119

Acronym

EUR-1066

Enrollment

Registered

2010-07-09

Start date

2010-08-02

Completion date

2011-07-01

Last updated

2020-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Pancreatitis

Keywords

Chronic Abdominal Pain, Exocrine Pancreatic Insufficiency

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.

Interventions

DRUGEUR-1066-A

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

DRUGZenpep

Capsules taken for daily for 28 days during treatment period 2

DRUGEUR-1066-B

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* Acute pancreatitis * Active alcohol consumption * Uncontrolled diabetes

Design outcomes

Primary

Measure	Time frame	Description
Comparing frequency and severity of pain	up to 84 days	Patient diary

Secondary

Measure	Time frame	Description
Changes in fat malabsorption	up to 124 days	Assess the coefficient of fat absorption

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026