Creon After Pancreatic Surgery

One Week Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Multi-Center Study With Creon® 25000 Minimicrospheres™ in Subjects With Pancreatic Exocrine Insufficiency After Pancreatic Surgery, Followed by an Open-Label Long-Term Extension of 1 Year

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00535756

Enrollment

Registered

2007-09-26

Start date

2008-04-30

Completion date

2011-06-30

Last updated

2011-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic Insufficiency

Keywords

Pancreatic Exocrine Insufficiency After Pancreatic Surgery

Brief summary

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

Interventions

DRUGCreon

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

DRUGPlacebo

Placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Change in CFA from baseline to the end of double blind treatment	7 days after baseline

Secondary

Measure	Time frame
CNA, stool fat, stool weight, nutritional parameters, clinical symptomatology, SF-36, BMI	7 days after baseline, and end of open-label period (1 year of open label treatment)

Countries

Bulgaria, Germany, Hungary, Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026