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Effect of Enzyme Therapy on Protein Metabolism in Chronic Pancreatitis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01154608
First Posted: July 1, 2010
Last Update Posted: July 1, 2010
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.
Collaborators:
National Research Agency, France
Solvay Pharmaceuticals
Information provided by:
Institut National de la Recherche Agronomique
  Purpose
Pancreatic exocrine insufficiency is known to impair nutrient absorption, especially fat, but few data exist about protein absorption. We aimed to investigate this question and assess the enzyme substitution efficiency using a sensitive method.

Condition Intervention
Pancreatitis Drug: Creon Other: No enzyme therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Primary Purpose: Basic Science

Resource links provided by NLM:


Further study details as provided by Institut National de la Recherche Agronomique:

Primary Outcome Measures:
  • transfer of dietary nitrogen to metabolic pools

Enrollment: 11
Study Start Date: April 2005
Arms Assigned Interventions
Experimental: pancreatic enzymes Drug: Creon
Placebo Comparator: control Other: No enzyme therapy
Current enzyme therapy of the patient is stopped during 7 days

  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Chronic pancreatitis
  • Pancreatic insufficiency
  • Enzyme therapy treatment

Exclusion Criteria:

  • Hepatic failure
  • Pregnancy
  • Positive serology to HIV, HCV, AGHbS, gastro-intestinal disease
  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): NCT01154608


Locations
France
Centre de Recherche sur Volontaires
Bobigny, France, 93000
Sponsors and Collaborators
Institut National de la Recherche Agronomique
National Research Agency, France
Solvay Pharmaceuticals
  More Information

Responsible Party: Pr Benamouzig, Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01154608     History of Changes
Other Study ID Numbers: PANCREATITE
First Submitted: June 30, 2010
First Posted: July 1, 2010
Last Update Posted: July 1, 2010
Last Verified: May 2010

Keywords provided by Institut National de la Recherche Agronomique:
Protein absorption in pancreatitis
Protein metabolism in pancreatitis

Additional relevant MeSH terms:
Pancreatitis
Pancreatic Diseases
Digestive System Diseases