Creon After Pancreatic Surgery

This study has been completed.
Sponsor:
Collaborators:
Quintiles
Data Map GmbH
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00535756
First received: September 25, 2007
Last updated: August 16, 2011
Last verified: August 2011
  Purpose

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 Intervention Phase
Pancreatic Insufficiency
Drug: Creon
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • Change in CFA from baseline to the end of double blind treatment [ Time Frame: 7 days after baseline ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

Enrollment: 58
Study Start Date: April 2008
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00535756

Locations
Bulgaria
Site Reference ID/Investigator# 45022
Ruse, Bulgaria, 7002
Site Reference ID/Investigator# 45020
Sofia, Bulgaria, 1233
Germany
Site Reference ID/Investigator# 45026
Greifswald, Germany, MV 17475
Site Reference ID/Investigator# 45025
Hamburg, Germany, 20246
Site Reference ID/Investigator# 45027
Heidelberg, Germany, 69120
Site Reference ID/Investigator# 45024
Munich, Germany, 81675
Hungary
Site Reference ID/Investigator# 45126
Bekescsaba, Hungary, 5600
Site Reference ID/Investigator# 45121
Budaors, Hungary, 2040
Site Reference ID/Investigator# 45127
Dunaujvaros, Hungary, 2400
Site Reference ID/Investigator# 45115
Gyula, Hungary, 5700
Site Reference ID/Investigator# 45116
Sopron, Hungary, 9400
Site Reference ID/Investigator# 45114
Szeged, Hungary, 6720
Italy
Site Reference ID/Investigator# 45130
Bologna, Italy, 40138
Site Reference ID/Investigator# 45129
Padova, Italy, 35128
Site Reference ID/Investigator# 45128
Verona, Italy, 37126
Sponsors and Collaborators
Abbott Products
Quintiles
Data Map GmbH
Investigators
Study Director: Guenter Krause, MD Abbott Products
  More Information

No publications provided

Responsible Party: Gregor Eibes/Clinical Trial Manager, Abbott Products
ClinicalTrials.gov Identifier: NCT00535756     History of Changes
Other Study ID Numbers: S245.4.008, 2005-004854-29
Study First Received: September 25, 2007
Last Updated: August 16, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Abbott:
Pancreatic Exocrine Insufficiency After Pancreatic Surgery

Additional relevant MeSH terms:
Exocrine Pancreatic Insufficiency
Pancreatic Diseases
Digestive System Diseases
Pancreatin
Pancrelipase
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 15, 2014