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NCT00957151 Clinical Trial

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

Chronic Pancreatitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00957151
Other study ID # 04007
Secondary ID
Status Completed
Phase Phase 4
First received August 11, 2009
Last updated August 11, 2009
Start date April 2004
Est. completion date August 2005

Study information
Verified date August 2009
Source Hospital Avicenne
Contact n/a
Is FDA regulated No
Health authority France: National Consultative Ethics Committee for Health and Life Sciences
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 12
Est. completion date August 2005
Est. primary completion date August 2005
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Creon

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Hospital Avicenne Solvay Pharmaceuticals

Outcome
Type Measure Description Time frame Safety issue
Primary To measure digestive and metabolic assimilation of dietary proteins in patients with chronic pancreatitis
Secondary To determine the efficacy of enzyme therapy
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