Creon After Pancreatic Surgery

• Status: Completed
• Trial end date: 2011-06-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Abbott Products
• Collaborators: Data Map GmbH; Quintiles, Inc.
• Treatments: Pancreatin; Pancrelipase

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