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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

July 5, 2010
July 7, 2010
August 2010
June 2011   (final data collection date for primary outcome measure)
Comparing frequency and severity of pain [ Time Frame: up to 84 days ] [ Designated as safety issue: Yes ]
Patient diary
Same as current
Complete list of historical versions of study NCT01159119 on ClinicalTrials.gov Archive Site
Changes in fat malabsorption [ Time Frame: up to 124 days ] [ Designated as safety issue: Yes ]
Assess the coefficient of fat absorption
Same as current
Not Provided
Not Provided
 
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

The purpose of this study is to evaluate two different treatments in subjects with chronic pancreatitis, exocrine pancreatic insufficiency and chronic abdominal pain.

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

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Chronic Pancreatitis
  • 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
  • Drug: Zenpep
    Capsules taken for daily for 28 days during treatment period 2
    Other Name: ZENPEP
  • 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
  • Experimental: EUR-1066-A
    Treatment with Eur-1006-A.
    Intervention: Drug: EUR-1066-A
  • Experimental: EUR-1066-B
    Treatment with Eur-1066-B
    Intervention: Drug: EUR-1066-B
  • Active Comparator: Zenpep
    Control Group: Consist of treatment with Zenpep
    Intervention: Drug: Zenpep
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
15
July 2011
June 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Acute pancreatitis
  • Active alcohol consumption
  • Uncontrolled diabetes
Both
18 Years and older
No
United States
 
NCT01159119
PR-012
No
Angelo Secci MD, Eurand
Eurand Pharmaceuticals
University of Florida
Principal Investigator: Phillip Toskes, MD University of Florida
Aptalis Pharma
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP