Back to resultsEvaluation of the Digestive and Metabolic Utilisation of Dietary Protein in Patients With Chronic Pancreatitis
Primary Purpose
Chronic Pancreatitis
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Creon
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Pancreatitis focused on measuring chronic pancreatitis, exocrine pancreatic insufficiency, enzyme therapy, patients with chronic pancreatitis and exocrine pancreatic insufficiency, taking enzyme replacement therapy
Eligibility Criteria
Inclusion Criteria:
- subjects with chronic pancreatitis and taking enzyme replacement therapy
Exclusion Criteria:
- patients with hepatic impairment
- patients allergic to dairy proteins
- urinary incontinence affecting the measurement of nitrogen metabolism
- digestive disorder affecting the absorption of nutrients
Sites / Locations
Outcomes
Primary Outcome Measures
To measure digestive and metabolic assimilation of dietary proteins in patients with chronic pancreatitis
Secondary Outcome Measures
To determine the efficacy of enzyme therapy
Full Information
NCT ID
NCT00957151
First Posted
August 11, 2009
Last Updated
August 11, 2009
Sponsor
Hospital Avicenne
Collaborators
Solvay Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT00957151
Brief Title
Evaluation of the Digestive and Metabolic Utilisation of Dietary Protein in Patients With Chronic Pancreatitis
Official Title
Evaluation of the Digestive and Metabolic Utilisation of Dietary Protein in Patients With Chronic Pancreatitis
Study Type
Interventional
2. Study Status
Record Verification Date
August 2009
Overall Recruitment Status
Completed
Study Start Date
April 2004 (undefined)
Primary Completion Date
August 2005 (Actual)
Study Completion Date
August 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Hospital Avicenne
Collaborators
Solvay Pharmaceuticals
4. Oversight
5. Study Description
Brief Summary
The objective is to evaluate the dietary nitrogen assimilation and metabolic utilisation capability of patients with chronic pancreatitis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pancreatitis
Keywords
chronic pancreatitis, exocrine pancreatic insufficiency, enzyme therapy, patients with chronic pancreatitis and exocrine pancreatic insufficiency, taking enzyme replacement therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Creon
Primary Outcome Measure Information:
Title
To measure digestive and metabolic assimilation of dietary proteins in patients with chronic pancreatitis
Secondary Outcome Measure Information:
Title
To determine the efficacy of enzyme therapy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
subjects with chronic pancreatitis and taking enzyme replacement therapy
Exclusion Criteria:
patients with hepatic impairment
patients allergic to dairy proteins
urinary incontinence affecting the measurement of nitrogen metabolism
digestive disorder affecting the absorption of nutrients
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Benamouzig, Pr
Organizational Affiliation
Department of Gastroenterology
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Evaluation of the Digestive and Metabolic Utilisation of Dietary Protein in Patients With Chronic Pancreatitis
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