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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 22, 2014