Creon After Pancreatic Surgery

Pancreatic Insufficiency Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00535756
• Other study ID #: S245.4.008
• Secondary ID: 2005-004854-29
• Status: Completed
• Phase: Phase 4
• First received: September 25, 2007
• Last updated: August 16, 2011
• Start date: April 2008
• Est. completion date: June 2011

Study information

• Verified date: August 2011
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Exocrine Pancreatic Insufficiency
• Pancreatic Insufficiency

Intervention

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

Locations

Country	Name	City	State
Bulgaria	Site Reference ID/Investigator# 45022	Ruse
Bulgaria	Site Reference ID/Investigator# 45020	Sofia
Germany	Site Reference ID/Investigator# 45026	Greifswald
Germany	Site Reference ID/Investigator# 45025	Hamburg
Germany	Site Reference ID/Investigator# 45027	Heidelberg
Germany	Site Reference ID/Investigator# 45024	Munich
Hungary	Site Reference ID/Investigator# 45126	Bekescsaba
Hungary	Site Reference ID/Investigator# 45121	Budaors
Hungary	Site Reference ID/Investigator# 45127	Dunaujvaros
Hungary	Site Reference ID/Investigator# 45115	Gyula
Hungary	Site Reference ID/Investigator# 45116	Sopron
Hungary	Site Reference ID/Investigator# 45114	Szeged
Italy	Site Reference ID/Investigator# 45130	Bologna
Italy	Site Reference ID/Investigator# 45129	Padova
Italy	Site Reference ID/Investigator# 45128	Verona

Sponsors (3)

Lead Sponsor	Collaborator
Abbott Products	Data Map GmbH, Quintiles, Inc.

Countries where clinical trial is conducted

Bulgaria,  Germany,  Hungary,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in CFA from baseline to the end of double blind treatment		7 days after baseline	No
Secondary	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)	No