Evaluation of the Digestive and Metabolic Utilisation of Dietary Protein in Patients With Chronic Pancreatitis
This study has been completed.
Sponsor:
Hospital Avicenne
Collaborator:
Solvay Pharmaceuticals
Information provided by:
Hospital Avicenne
ClinicalTrials.gov Identifier:
NCT00957151
First received: August 11, 2009
Last updated: NA
Last verified: August 2009
History: No changes posted
| Tracking Information | |||||
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| First Received Date ICMJE | August 11, 2009 | ||||
| Last Updated Date | August 11, 2009 | ||||
| Start Date ICMJE | April 2004 | ||||
| Primary Completion Date | August 2005 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
To measure digestive and metabolic assimilation of dietary proteins in patients with chronic pancreatitis | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
To determine the efficacy of enzyme therapy | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Evaluation of the Digestive and Metabolic Utilisation of Dietary Protein in Patients With Chronic Pancreatitis | ||||
| Official Title ICMJE | Evaluation of the Digestive and Metabolic Utilisation of Dietary Protein in Patients With Chronic Pancreatitis | ||||
| Brief Summary | The objective is to evaluate the dietary nitrogen assimilation and metabolic utilisation capability of patients with chronic pancreatitis. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 4 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Chronic Pancreatitis | ||||
| Intervention ICMJE | Drug: Creon | ||||
| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Estimated Enrollment ICMJE | 12 | ||||
| Completion Date | August 2005 | ||||
| Primary Completion Date | August 2005 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 65 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Not Provided | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00957151 | ||||
| Other Study ID Numbers ICMJE | 04007 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Pr Benamouzig Robert, AP-HP | ||||
| Study Sponsor ICMJE | Hospital Avicenne | ||||
| Collaborators ICMJE | Solvay Pharmaceuticals | ||||
| Investigators ICMJE |
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| Information Provided By | Hospital Avicenne | ||||
| Verification Date | August 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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