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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00957151
• Date of registration: 11/08/2009
• Prospective Registration: No
• Primary sponsor: Hospital Avicenne
• Public title: Evaluation of the Digestive and Metabolic Utilisation of Dietary Protein in Patients With Chronic Pancreatitis
• Scientific title: Evaluation of the Digestive and Metabolic Utilisation of Dietary Protein in Patients With Chronic Pancreatitis
• Date of first enrolment: April 2004
• Target sample size: 12
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00957151
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 4

Countries of recruitment

France

Contacts

• Name: Robert Benamouzig, Pr
• Affiliation: Department of Gastroenterology

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Chronic Pancreatitis

Intervention(s)

Drug: Creon

Primary Outcome(s)

To measure digestive and metabolic assimilation of dietary proteins in patients with chronic pancreatitis

Secondary Outcome(s)

To determine the efficacy of enzyme therapy

Secondary ID(s)

04007

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Solvay Pharmaceuticals