Effect of Enzyme Therapy on Protein Metabolism in Chronic... | NCT01154608

Studies
Effect of Enzyme Therapy on Protein Metabolism in Chronic Pancreatitis

NCT01154608

Sponsor

Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement

Status

Completed

Last Update Posted

Oct 6, 2025Actual

Enrollment

11Actual

Phase

Not Applicable

Conditions

Pancreatitis

Interventions

Creon
No enzyme therapy

Countries

France

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

May 2010

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 2005

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Jun 30, 2010

First Submission Date that Met QC Criteria

Jun 30, 2010

First Posted Date

Jul 1, 2010Estimated

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

Oct 1, 2025

Last Update Posted Date

Oct 6, 2025Actual

Name	Class
National Research Agency, France	OTHER
Solvay Pharmaceuticals	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

11Actual

Label	Type	Description	Intervention Names
pancreatic enzymes	Experimental		Drug: Creon
control	Placebo Comparator		Other: No enzyme therapy

Name	Type	Description	Arm Group Labels	Other Names
Creon	Drug		pancreatic enzymes
No enzyme therapy

Measure	Description	Time Frame
transfer of dietary nitrogen to metabolic pools

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Chronic pancreatitis
Pancreatic insufficiency
Enzyme therapy treatment

Exclusion Criteria:

Hepatic failure
Pregnancy
Positive serology to HIV, HCV, AGHbS, gastro-intestinal disease

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre de Recherche sur Volontaires		Bobigny		93000	France

Condition Browse Module

MeSH Terms

ID	Term
D010195	Pancreatitis

Ancestor Terms

ID	Term
D010182	Pancreatic Diseases
D004066	Digestive System Diseases

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