Creon After Pancreatic Surgery | NCT00535756

Studies
Creon After Pancreatic Surgery

NCT00535756

Sponsor

Abbott Products

Status

Completed

Last Update Posted

Aug 18, 2011Estimated

Enrollment

58Actual

Phase

Phase 4

Conditions

Pancreatic Insufficiency

Interventions

Creon
Placebo

Countries

Bulgaria
Germany
Hungary
Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2005-004854-29	EudraCT Number

Status Module

Record Verification Date

Aug 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2008

Primary Completion Date

Jun 2011Actual

Completion Date

Jun 2011Actual

First Submitted Date

Sep 25, 2007

First Submission Date that Met QC Criteria

Sep 25, 2007

First Posted Date

Sep 26, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 16, 2011

Last Update Posted Date

Aug 18, 2011Estimated

Name	Class
Quintiles, Inc.	INDUSTRY
Data Map GmbH	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

58Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental		Drug: Creon
2	Placebo Comparator		Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Creon	Drug	3 capsules Creon with 25000 lipase units per main meal (3 main meals) plus 2 capsules per snack (2-3 snacks)	1

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	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)

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Guenter Krause, MD	Abbott Products	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Site Reference ID/Investigator# 45022		Rousse		7002	Bulgaria
Site Reference ID/Investigator# 45020

Condition Browse Module

MeSH Terms

ID	Term
D010188	Exocrine Pancreatic Insufficiency

Ancestor Terms

ID	Term
D010182	Pancreatic Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D020799	Pancrelipase

Ancestor Terms

ID	Term
D008049	Lipase
D002265	Carboxylic Ester Hydrolases
D004950	Esterases
D006867	Hydrolases

Browse Leaves

Not provided

Browse Branches

Not provided