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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
History of Changes

September 25, 2007
August 16, 2011
April 2008
June 2011   (final data collection date for primary outcome measure)
Change in CFA from baseline to the end of double blind treatment [ Time Frame: 7 days after baseline ] [ Designated as safety issue: No ]
Change in CFA (coefficient of fat absorption) from baseline to the end of double blind treatment
Complete list of historical versions of study NCT00535756 on ClinicalTrials.gov Archive Site
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 ]
CNA (coefficient of nitrogen absorption), stool fat, stool weight, nutritional laboratory parameters, clinical symptomatology, Quality of life (QqL) using GIQLI (Gastrointestinal Quality of Life Index), Body Mass Index (BMI)
Not Provided
Not Provided
 
Creon After Pancreatic Surgery
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
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Pancreatic Insufficiency
  • Drug: Creon
    3 capsules Creon with 25000 lipase units per main meal (3 main meals) plus 2 capsules per snack (2-3 snacks)
  • Drug: Placebo
    Placebo
  • Experimental: 1
    Intervention: Drug: Creon
  • Placebo Comparator: 2
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
58
June 2011
June 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Bulgaria,   Germany,   Hungary,   Italy
 
NCT00535756
S245.4.008, 2005-004854-29
No
Gregor Eibes/Clinical Trial Manager, Abbott Products
Abbott Products
  • Quintiles
  • Data Map GmbH
Study Director: Guenter Krause, MD Abbott Products
Abbott
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP