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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by Forest Laboratories.
Recruitment status was  Not yet recruiting
University of Florida
Information provided by:
Forest Laboratories
ClinicalTrials.gov Identifier:
First received: July 5, 2010
Last updated: July 7, 2010
Last verified: July 2010
The purpose of this study is to evaluate two different treatments in subjects with chronic pancreatitis, exocrine pancreatic insufficiency and chronic abdominal pain.

Condition Intervention Phase
Chronic Pancreatitis
Drug: EUR-1066-A
Drug: Zenpep
Drug: EUR-1066-B
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Forest Laboratories:

Primary Outcome Measures:
  • Comparing frequency and severity of pain [ Time Frame: up to 84 days ] [ Designated as safety issue: Yes ]
    Patient diary

Secondary Outcome Measures:
  • Changes in fat malabsorption [ Time Frame: up to 124 days ] [ Designated as safety issue: Yes ]
    Assess the coefficient of fat absorption

Estimated Enrollment: 15
Study Start Date: August 2010
Estimated Study Completion Date: July 2011
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: EUR-1066-A
Treatment with Eur-1006-A.
Drug: EUR-1066-A
Eur-1066 capsules taken daily for 28 days either during treatment period 1 or treatment period 3.
Other Name: EUR-1066
Experimental: EUR-1066-B
Treatment with Eur-1066-B
Drug: EUR-1066-B
Eur-1066 capsules taken daily for 28 days either during treatment period 1 or treatment period 3.
Other Name: EUR-1066
Active Comparator: Zenpep
Control Group: Consist of treatment with Zenpep
Drug: Zenpep
Capsules taken for daily for 28 days during treatment period 2

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • Acute pancreatitis
  • Active alcohol consumption
  • Uncontrolled diabetes
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01159119

United States, Florida
University of Florida Not yet recruiting
Gainesville, Florida, United States, 32611
Contact: Cheryl Curington    352-392-6293    cheryl.curington@medicine.ufl.edu   
Principal Investigator: Phillip Toskes, MD         
Sponsors and Collaborators
Eurand Pharmaceuticals
University of Florida
Principal Investigator: Phillip Toskes, MD University of Florida
  More Information

Responsible Party: Angelo Secci MD, Eurand
ClinicalTrials.gov Identifier: NCT01159119     History of Changes
Other Study ID Numbers: PR-012 
Study First Received: July 5, 2010
Last Updated: July 7, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Forest Laboratories:
Chronic Abdominal Pain
Exocrine Pancreatic Insufficiency

Additional relevant MeSH terms:
Abdominal Pain
Exocrine Pancreatic Insufficiency
Pancreatitis, Chronic
Digestive System Diseases
Nervous System Diseases
Neurologic Manifestations
Pancreatic Diseases
Signs and Symptoms
Signs and Symptoms, Digestive

ClinicalTrials.gov processed this record on May 24, 2016