Effect of Enzyme Therapy on Protein Metabolism in Chronic Pancreatitis

NCT ID: NCT01154608

Last Updated: 2025-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-04-30

Brief Summary

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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

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Conditions

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Pancreatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Study Groups

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pancreatic enzymes

Group Type EXPERIMENTAL

Creon

Intervention Type DRUG

control

Group Type PLACEBO_COMPARATOR

No enzyme therapy

Intervention Type OTHER

Current enzyme therapy of the patient is stopped during 7 days

Interventions

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Creon

Intervention Type DRUG

No enzyme therapy

Current enzyme therapy of the patient is stopped during 7 days

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Chronic pancreatitis
* Pancreatic insufficiency
* Enzyme therapy treatment

Exclusion Criteria

* Hepatic failure
* Pregnancy
* Positive serology to HIV, HCV, AGHbS, gastro-intestinal disease
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Research Agency, France

OTHER

Sponsor Role collaborator

Solvay Pharmaceuticals

INDUSTRY

Sponsor Role collaborator

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

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Centre de Recherche sur Volontaires

Bobigny, , France

Site Status

Countries

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France

Other Identifiers

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PANCREATITE

Identifier Type: -

Identifier Source: org_study_id

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