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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by Aptalis Pharma.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
University of Florida
Information provided by:
Aptalis Pharma
ClinicalTrials.gov Identifier:
NCT01159119
First received: July 5, 2010
Last updated: July 7, 2010
Last verified: July 2010
  Purpose

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 Aptalis Pharma:

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
Other Name: ZENPEP

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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 Aptalis Pharma:
Chronic Abdominal Pain
Exocrine Pancreatic Insufficiency

Additional relevant MeSH terms:
Abdominal Pain
Exocrine Pancreatic Insufficiency
Pancreatitis
Pancreatitis, Chronic
Pain
Signs and Symptoms
Signs and Symptoms, Digestive
Pancreatic Diseases
Digestive System Diseases
Pancreatin
Pancrelipase
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014