Creon After Pancreatic Surgery

Abbott

Status and phase: Completed; Phase 4

Conditions: Pancreatic Insufficiency

Treatments: Drug: Placebo; Drug: Creon

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT00535756

2005-004854-29 (EudraCT Number)

S245.4.008

Details and patient eligibility

About

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

Enrollment: 58 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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58 participants in 2 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: Creon

2

Placebo Comparator group

Treatment:

Drug: Placebo