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

This study has been completed.
Sponsor:
Collaborator:
Solvay Pharmaceuticals
Information provided by:
Hospital Avicenne
ClinicalTrials.gov Identifier:
NCT00957151
First received: August 11, 2009
Last updated: NA
Last verified: August 2009
History: No changes posted
  Purpose

The objective is to evaluate the dietary nitrogen assimilation and metabolic utilisation capability of patients with chronic pancreatitis.


Condition Intervention Phase
Chronic Pancreatitis
Drug: Creon
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of the Digestive and Metabolic Utilisation of Dietary Protein in Patients With Chronic Pancreatitis

Resource links provided by NLM:


Further study details as provided by Hospital Avicenne:

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

Estimated Enrollment: 12
Study Start Date: April 2004
Study Completion Date: August 2005
Primary Completion Date: August 2005 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00957151

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

No publications provided

Responsible Party: Pr Benamouzig Robert, AP-HP
ClinicalTrials.gov Identifier: NCT00957151     History of Changes
Other Study ID Numbers: 04007
Study First Received: August 11, 2009
Last Updated: August 11, 2009
Health Authority: France: National Consultative Ethics Committee for Health and Life Sciences

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
Exocrine Pancreatic Insufficiency
Pancreatic Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on April 21, 2014