Creon After Pancreatic Surgery

Abbott Products58 enrolled

Overview

This study will provide efficacy data for Creon 25000 MMS in PS patients as well as long-term safety data. During the long-term treatment with Creon 25000 nutritional parameters will be assessed and correlated with CFA

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Pancreatic Insufficiency

Interventions

CreonDRUG

3 capsules Creon with 25000 lipase units per main meal (3 main meals) plus 2 capsules per snack (2-3 snacks)

PlaceboDRUG

Placebo

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria Pancreatic exocrine insufficiency has to be proven (in medical history) by the following criteria: * Direct or indirect pancreatic function test (except stool fat excretion) and * Steatorrhoea: stool fat \> 15 g/day (using van de Kamer method) * Proven chronic pancreatitis * Females of child-bearing potential must agree to continue using a medically acceptable method of birth control Exclusion Criteria * Subjects in an unstable situation (catabolic) after pancreatic surgery * Ileus or acute abdomen * Current excessive intake of alcohol or drug abuse * Hypersensitivity vs porcine proteins / pancreatin * Subjects taking digestive enzyme preparations have to stop them before start of the run-in period

Locations (15)

Site Reference ID/Investigator# 45022

Rousse, Bulgaria

Site Reference ID/Investigator# 45020

Sofia, Bulgaria

Site Reference ID/Investigator# 45026

Greifswald, Germany

Outcomes

Primary Outcomes

Change in CFA from baseline to the end of double blind treatment

Time frame: 7 days after baseline

Secondary Outcomes

CNA, stool fat, stool weight, nutritional parameters, clinical symptomatology, SF-36, BMI

Time frame: 7 days after baseline, and end of open-label period (1 year of open label treatment)

Data from ClinicalTrials.gov

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