Creon After Pancreatic Surgery

August 16, 2011 updated by: Abbott Products

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

58

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
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)
7 days after baseline, and end of open-label period (1 year of open label treatment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Products

Collaborators

Quintiles, Inc.
Data Map GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

September 25, 2007

First Submitted That Met QC Criteria

September 25, 2007

First Posted (Estimate)

September 26, 2007

Study Record Updates

Last Update Posted (Estimate)

August 18, 2011

Last Update Submitted That Met QC Criteria

August 16, 2011

Last Verified

August 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S245.4.008
  • 2005-004854-29 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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