Creon After Pancreatic Surgery

• Sponsor: Abbott Products (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00535756
• Collaborator: Quintiles, Inc. (Industry), Data Map GmbH (Other)
• Enrollment: 58
• Locations: 15
• Arms: 2
• Duration (Months): 38
• Patients Per Site: 3.9
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Pancreatic Insufficiency	Drug: Creon; Drug: Placebo	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 58 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, 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
• Study Start Date: Apr 1, 2008
• Actual Primary Completion Date: Jun 1, 2011
• Actual Study Completion Date: Jun 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. Change in CFA from baseline to the end of double blind treatment [7 days after baseline]

Secondary Outcome Measures

1. 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)]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Site Reference ID/Investigator# 45022	Ruse		Bulgaria	7002
2	Site Reference ID/Investigator# 45020	Sofia		Bulgaria	1233
3	Site Reference ID/Investigator# 45026	Greifswald		Germany	MV 17475
4	Site Reference ID/Investigator# 45025	Hamburg		Germany	20246
5	Site Reference ID/Investigator# 45027	Heidelberg		Germany	69120
6	Site Reference ID/Investigator# 45024	Munich		Germany	81675
7	Site Reference ID/Investigator# 45126	Bekescsaba		Hungary	5600
8	Site Reference ID/Investigator# 45121	Budaors		Hungary	2040
9	Site Reference ID/Investigator# 45127	Dunaujvaros		Hungary	2400
10	Site Reference ID/Investigator# 45115	Gyula		Hungary	5700
11	Site Reference ID/Investigator# 45116	Sopron		Hungary	9400
12	Site Reference ID/Investigator# 45114	Szeged		Hungary	6720
13	Site Reference ID/Investigator# 45130	Bologna		Italy	40138
14	Site Reference ID/Investigator# 45129	Padova		Italy	35128
15	Site Reference ID/Investigator# 45128	Verona		Italy	37126

Sponsors and Collaborators

• Abbott Products
• Quintiles, Inc.
• Data Map GmbH

Investigators

• Study Director: Guenter Krause, MD, Abbott Products

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00535756
• Other Study ID Numbers: S245.4.008; 2005-004854-29
• First Posted: Sep 26, 2007
• Last Update Posted: Aug 18, 2011
• Last Verified: Aug 1, 2011

• Keywords provided by , ,: Pancreatic Exocrine Insufficiency After Pancreatic Surgery
• Additional relevant MeSH terms: Exocrine Pancreatic Insufficiency

Study Results

No Results Posted as of Aug 18, 2011