Clinical trial NCT00535756: Creon After Pancreatic Surgery
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pancreatic Insufficiency
Keywords: Pancreatic Exocrine Insufficiency After Pancreatic Surgery
Lead sponsor: Abbott
Sponsor class: INDUSTRY
Collaborators: name: Quintiles, Inc.
name: Data Map GmbH
First posted: 2007-09-26
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Change in CFA from baseline to the end of double blind treatment
timeFrame: 7 days after baseline
Secondary outcomes:
measure: CNA, stool fat, stool weight, nutritional parameters, clinical symptomatology, SF-36, BMI
timeFrame: 7 days after baseline, and end of open-label period (1 year of open label treatment)
Other outcomes:
Locations:
city: Ruse
country: Bulgaria
facility: Site Reference ID/Investigator# 45022
city: Sofia
country: Bulgaria
facility: Site Reference ID/Investigator# 45020
city: Greifswald
country: Germany
facility: Site Reference ID/Investigator# 45026
city: Hamburg
country: Germany
facility: Site Reference ID/Investigator# 45025
city: Heidelberg
country: Germany
facility: Site Reference ID/Investigator# 45027
city: Munich
country: Germany
facility: Site Reference ID/Investigator# 45024
city: Bekescsaba
country: Hungary
facility: Site Reference ID/Investigator# 45126
city: Budaors
country: Hungary
facility: Site Reference ID/Investigator# 45121
city: Dunaujvaros
country: Hungary
facility: Site Reference ID/Investigator# 45127
city: Gyula
country: Hungary
facility: Site Reference ID/Investigator# 45115
city: Sopron
country: Hungary
facility: Site Reference ID/Investigator# 45116
city: Szeged
country: Hungary
facility: Site Reference ID/Investigator# 45114
city: Bologna
country: Italy
facility: Site Reference ID/Investigator# 45130
city: Padova
country: Italy
facility: Site Reference ID/Investigator# 45129
city: Verona
country: Italy
facility: Site Reference ID/Investigator# 45128
Study officials:
affiliation: Abbott Products
name: Guenter Krause, MD
role: STUDY_DIRECTOR
References: