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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. The completion date has passed and the status has not been verified in more than two years.
Verified July 2010 by Forest Laboratories.
Recruitment status was:  Not yet recruiting
University of Florida
Information provided by:
Forest Laboratories 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
Intervention Model: Crossover Assignment
Masking: Double (Participant, Care Provider)
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 ]
    Patient diary

Secondary Outcome Measures:
  • Changes in fat malabsorption [ Time Frame: up to 124 days ]
    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   (Adult, Senior)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01159119

United States, Florida
University of Florida Not yet recruiting
Gainesville, Florida, United States, 32611
Contact: Cheryl Curington    352-392-6293   
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 Identifier: NCT01159119     History of Changes
Other Study ID Numbers: PR-012
Study First Received: July 5, 2010
Last Updated: July 7, 2010

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

Additional relevant MeSH terms:
Abdominal Pain
Pancreatitis, Chronic
Exocrine Pancreatic Insufficiency
Pancreatic Diseases
Digestive System Diseases
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Signs and Symptoms, Digestive
Gastrointestinal Agents processed this record on September 19, 2017