Evaluation of the Digestive and Metabolic Utilisation of... | NCT00957151

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

NCT00957151

Sponsor

Hospital Avicenne

Status

Completed

Last Update Posted

Aug 12, 2009Estimated

Enrollment

12Estimated

Phase

Phase 4

Conditions

Chronic Pancreatitis

Interventions

Creon

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2004

Primary Completion Date

Aug 2005Actual

Completion Date

Aug 2005Actual

First Submitted Date

Aug 11, 2009

First Submission Date that Met QC Criteria

Aug 11, 2009

First Posted Date

Aug 12, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 11, 2009

Last Update Posted Date

Aug 12, 2009Estimated

Name	Class
Solvay Pharmaceuticals	INDUSTRY

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Estimated

Name	Type	Description	Arm Group Labels	Other Names
Creon	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To measure digestive and metabolic assimilation of dietary proteins in patients with chronic pancreatitis

Secondary Outcomes

Measure	Description	Time Frame
To determine the efficacy of enzyme therapy

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Robert Benamouzig, Pr	Department of Gastroenterology	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D050500	Pancreatitis, Chronic
D010188	Exocrine Pancreatic Insufficiency

Ancestor Terms

ID	Term
D010195	Pancreatitis
D010182	Pancreatic Diseases
D004066	Digestive System Diseases
D002908	Chronic Disease

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D020799	Pancrelipase

Ancestor Terms

ID	Term
D008049	Lipase
D002265	Carboxylic Ester Hydrolases
D004950	Esterases
D006867	Hydrolases

Browse Leaves

Not provided

Browse Branches

Not provided