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

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ClinicalTrials.gov Identifier: NCT01159119
Recruitment Status : Unknown
Verified July 2010 by Forest Laboratories.
Recruitment status was:  Not yet recruiting
First Posted : July 9, 2010
Last Update Posted : July 9, 2010
Sponsor:
Collaborator:
University of Florida
Information provided by:
Forest Laboratories

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.

Condition or disease Intervention/treatment Phase
Chronic Pancreatitis Drug: EUR-1066-A Drug: Zenpep Drug: EUR-1066-B Phase 1

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
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
Study Start Date : August 2010
Estimated Primary Completion Date : June 2011
Estimated Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Comparing frequency and severity of pain [ Time Frame: up to 84 days ]
    Patient diary


Secondary Outcome Measures :
  1. Changes in fat malabsorption [ Time Frame: up to 124 days ]
    Assess the coefficient of fat absorption



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Acute pancreatitis
  • Active alcohol consumption
  • Uncontrolled diabetes

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01159119


Locations
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
Investigators
Principal Investigator: Phillip Toskes, MD University of Florida

Responsible Party: Angelo Secci MD, Eurand
ClinicalTrials.gov Identifier: NCT01159119     History of Changes
Other Study ID Numbers: PR-012
First Posted: July 9, 2010    Key Record Dates
Last Update Posted: July 9, 2010
Last Verified: July 2010

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

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