Effect of Enzyme Therapy on Protein Metabolism in Chronic Pancreatitis

This study has been completed.

Sponsor:

Collaborators:

National Research Agency, France

Solvay Pharmaceuticals

Information provided by:

Institut National de la Recherche Agronomique

ClinicalTrials.gov Identifier:

NCT01154608

First received: June 30, 2010

Last updated: NA

Last verified: May 2010

History: No changes posted

Tracking Information
First Received Date ^ICMJE	June 30, 2010
Last Updated Date	June 30, 2010
Start Date ^ICMJE	April 2005
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE (submitted: June 30, 2010)	transfer of dietary nitrogen to metabolic pools [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	No Changes Posted
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Effect of Enzyme Therapy on Protein Metabolism in Chronic Pancreatitis
Official Title ^ICMJE	Not Provided
Brief Summary	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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Crossover Assignment Primary Purpose: Basic Science
Condition ^ICMJE	Pancreatitis
Intervention ^ICMJE	Drug: Creon Other: No enzyme therapy Current enzyme therapy of the patient is stopped during 7 days
Study Arm (s)	Experimental: pancreatic enzymes Intervention: Drug: Creon Placebo Comparator: control Intervention: Other: No enzyme therapy
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	11
Completion Date	Not Provided
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	Inclusion Criteria: Chronic pancreatitis Pancreatic insufficiency Enzyme therapy treatment Exclusion Criteria: Hepatic failure Pregnancy Positive serology to HIV, HCV, AGHbS, gastro-intestinal disease
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	France

Administrative Information
NCT Number ^ICMJE	NCT01154608
Other Study ID Numbers ^ICMJE	PANCREATITE
Has Data Monitoring Committee	Yes
Responsible Party	Pr Benamouzig, Assistance Publique - Hôpitaux de Paris
Study Sponsor ^ICMJE	Institut National de la Recherche Agronomique
Collaborators ^ICMJE	National Research Agency, France Solvay Pharmaceuticals
Investigators ^ICMJE	Not Provided
Information Provided By	Institut National de la Recherche Agronomique
Verification Date	May 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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