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Evaluation of the Digestive and Metabolic Utilisation of Dietary Protein in Patients With Chronic Pancreatitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00957151
Recruitment Status : Completed
First Posted : August 12, 2009
Last Update Posted : August 12, 2009
Sponsor:
Collaborator:
Information provided by:

Study Description
Brief Summary:
The objective is to evaluate the dietary nitrogen assimilation and metabolic utilisation capability of patients with chronic pancreatitis.

Condition or disease Intervention/treatment Phase
Chronic Pancreatitis Drug: Creon Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the Digestive and Metabolic Utilisation of Dietary Protein in Patients With Chronic Pancreatitis
Study Start Date : April 2004
Primary Completion Date : August 2005
Study Completion Date : August 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. To measure digestive and metabolic assimilation of dietary proteins in patients with chronic pancreatitis

Secondary Outcome Measures :
  1. To determine the efficacy of enzyme therapy

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

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): NCT00957151


Sponsors and Collaborators
Hospital Avicenne
Solvay Pharmaceuticals
Investigators
Principal Investigator: Robert Benamouzig, Pr Department of Gastroenterology
More Information

Responsible Party: Pr Benamouzig Robert, AP-HP
ClinicalTrials.gov Identifier: NCT00957151     History of Changes
Other Study ID Numbers: 04007
First Posted: August 12, 2009    Key Record Dates
Last Update Posted: August 12, 2009
Last Verified: August 2009

Keywords provided by Hospital Avicenne:
chronic pancreatitis
exocrine pancreatic insufficiency
enzyme therapy
patients with chronic pancreatitis and exocrine pancreatic insufficiency
taking enzyme replacement therapy

Additional relevant MeSH terms:
Pancreatitis
Pancreatitis, Chronic
Pancreatic Diseases
Digestive System Diseases