Trial | NCT00535756  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    58
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 Started
Apr 30
2008
Primary Completion
Jun 30
2011
Study Completion
Jun 30
2011
Last Update
Aug 18
2011
Estimate

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

1 Experimental

2 Placebo Comparator

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
No Results Posted