Creon After Pancreatic Surgery - Full Text View

Sponsor:	Abbott Products
Collaborators:	Quintiles Data Map GmbH
Information provided by:	Abbott
ClinicalTrials.gov Identifier:	NCT00535756

Purpose

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

Condition	Intervention	Phase
Pancreatic Insufficiency	Drug: Creon Drug: Placebo	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
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

Resource links provided by NLM:

Drug Information available for: Pancrelipase Ultrase

U.S. FDA Resources

Further study details as provided by Abbott:

Primary Outcome Measures:

Change in CFA from baseline to the end of double blind treatment [ Time Frame: 7 days after baseline ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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) ] [ Designated as safety issue: No ]

Enrollment:	58
Study Start Date:	April 2008
Study Completion Date:	June 2011
Primary Completion Date:	June 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	Drug: Creon 3 capsules Creon with 25000 lipase units per main meal (3 main meals) plus 2 capsules per snack (2-3 snacks)
Placebo Comparator: 2	Drug: Placebo Placebo

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00535756

Locations

Bulgaria
Site Reference ID/Investigator# 45022
Ruse, Bulgaria, 7002
Site Reference ID/Investigator# 45020
Sofia, Bulgaria, 1233
Germany
Site Reference ID/Investigator# 45026
Greifswald, Germany, MV 17475
Site Reference ID/Investigator# 45025
Hamburg, Germany, 20246
Site Reference ID/Investigator# 45027
Heidelberg, Germany, 69120
Site Reference ID/Investigator# 45024
Munich, Germany, 81675
Hungary
Site Reference ID/Investigator# 45126
Bekescsaba, Hungary, 5600
Site Reference ID/Investigator# 45121
Budaors, Hungary, 2040
Site Reference ID/Investigator# 45127
Dunaujvaros, Hungary, 2400
Site Reference ID/Investigator# 45115
Gyula, Hungary, 5700
Site Reference ID/Investigator# 45116
Sopron, Hungary, 9400
Site Reference ID/Investigator# 45114
Szeged, Hungary, 6720
Italy
Site Reference ID/Investigator# 45130
Bologna, Italy, 40138
Site Reference ID/Investigator# 45129
Padova, Italy, 35128
Site Reference ID/Investigator# 45128
Verona, Italy, 37126

Sponsors and Collaborators

Abbott Products

Quintiles

Data Map GmbH

Investigators

Study Director:

Guenter Krause, MD

Abbott Products

More Information

No publications provided

Responsible Party:	Gregor Eibes/Clinical Trial Manager, Abbott Products
ClinicalTrials.gov Identifier:	NCT00535756 History of Changes
Other Study ID Numbers:	S245.4.008, 2005-004854-29
Study First Received:	September 25, 2007
Last Updated:	August 16, 2011
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Abbott:

Pancreatic Exocrine Insufficiency After Pancreatic Surgery

Additional relevant MeSH terms:

Exocrine Pancreatic Insufficiency
Pancreatic Diseases
Digestive System Diseases
Pancrelipase

Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012