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Creon After Pancreatic Surgery

Primary Purpose

Pancreatic Insufficiency

Status

Completed

Phase

Phase 4

Locations

International

Study Type

Interventional

Intervention

Creon

Placebo

About this trial

This is an interventional treatment trial for Pancreatic Insufficiency focused on measuring Pancreatic Exocrine Insufficiency After Pancreatic Surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

Change in CFA from baseline to the end of double blind treatment

Secondary Outcome Measures

CNA, stool fat, stool weight, nutritional parameters, clinical symptomatology, SF-36, BMI

Full Information

NCT ID

NCT00535756

First Posted

September 25, 2007

Last Updated

August 16, 2011

Sponsor

Abbott Products

Collaborators

Quintiles, Inc., Data Map GmbH

1. Study Identification

Unique Protocol Identification Number

NCT00535756

Brief Title

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

2. Study Status

Record Verification Date

August 2011

Overall Recruitment Status

Completed

Study Start Date

April 2008 (undefined)

Primary Completion Date

June 2011 (Actual)

Study Completion Date

June 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Abbott Products

Collaborators

Quintiles, Inc., Data Map GmbH

4. Oversight

Data Monitoring Committee

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pancreatic Insufficiency

Keywords

Pancreatic Exocrine Insufficiency After Pancreatic Surgery

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

58 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Creon

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo

Primary Outcome Measure Information:

Title

Change in CFA from baseline to the end of double blind treatment

Time Frame

7 days after baseline

Secondary Outcome Measure Information:

Title

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)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Guenter Krause, MD

Organizational Affiliation

Abbott Products

Official's Role

Study Director

Facility Information:

Facility Name

Site Reference ID/Investigator# 45022

City

Ruse

ZIP/Postal Code

7002

Country

Bulgaria

Facility Name

Site Reference ID/Investigator# 45020

City

Sofia

ZIP/Postal Code

1233

Country

Bulgaria

Facility Name

Site Reference ID/Investigator# 45026

City

Greifswald

ZIP/Postal Code

MV 17475

Country

Germany

Facility Name

Site Reference ID/Investigator# 45025

City

Hamburg

ZIP/Postal Code

20246

Country

Germany

Facility Name

Site Reference ID/Investigator# 45027

City

Heidelberg

ZIP/Postal Code

69120

Country

Germany

Facility Name

Site Reference ID/Investigator# 45024

City

Munich

ZIP/Postal Code

81675

Country

Germany

Facility Name

Site Reference ID/Investigator# 45126

City

Bekescsaba

ZIP/Postal Code

5600

Country

Hungary

Facility Name

Site Reference ID/Investigator# 45121

City

Budaors

ZIP/Postal Code

2040

Country

Hungary

Facility Name

Site Reference ID/Investigator# 45127

City

Dunaujvaros

ZIP/Postal Code

2400

Country

Hungary

Facility Name

Site Reference ID/Investigator# 45115

City

Gyula

ZIP/Postal Code

5700

Country

Hungary

Facility Name

Site Reference ID/Investigator# 45116

City

Sopron

ZIP/Postal Code

9400

Country

Hungary

Facility Name

Site Reference ID/Investigator# 45114

City

Szeged

ZIP/Postal Code

6720

Country

Hungary

Facility Name

Site Reference ID/Investigator# 45130

City

Bologna

ZIP/Postal Code

40138

Country

Italy

Facility Name

Site Reference ID/Investigator# 45129

City

Padova

ZIP/Postal Code

35128

Country

Italy

Facility Name

Site Reference ID/Investigator# 45128

City

Verona

ZIP/Postal Code

37126

Country

Italy

12. IPD Sharing Statement

Learn more about this trial

Creon After Pancreatic Surgery

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Creon After Pancreatic Surgery

Pancreatic Insufficiency

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial