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NCT01154608 Clinical Trial

Effect of Enzyme Therapy on Protein Metabolism in Chronic Pancreatitis

Pancreatitis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01154608
Other study ID # PANCREATITE
Secondary ID
Status Completed
Phase N/A
First received June 30, 2010
Last updated June 30, 2010
Start date April 2005

Study information
Verified date May 2010
Source Institut National de la Recherche Agronomique
Contact n/a
Is FDA regulated No
Health authority France: Health Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 11
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Chronic pancreatitis

- Pancreatic insufficiency

- Enzyme therapy treatment

Exclusion Criteria:

- Hepatic failure

- Pregnancy

- Positive serology to HIV, HCV, AGHbS, gastro-intestinal disease

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Primary Purpose: Basic Science

Related Conditions & MeSH terms

Intervention

Drug:
• Creon

Other:
• No enzyme therapy
Current enzyme therapy of the patient is stopped during 7 days

Locations
Country Name City State
France Centre de Recherche sur Volontaires Bobigny

Sponsors (3)
Lead Sponsor Collaborator
Institut National de la Recherche Agronomique National Research Agency, France, Solvay Pharmaceuticals

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary transfer of dietary nitrogen to metabolic pools Yes
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