Enzyme Substitution in Exocrine Pancreatic Insufficiency; Self Administration Against a Fixed Dose Regimen (SAPES)

NCT01430234 Phase 4 COMPLETED

Treatment of exocrine insufficiency (EPI) consists of pancreatic enzyme replacement according to the fat intake. Prescribing a sufficient dose of pancreatic enzymes is mandatory for the treatment to be effective. In addition, consultation of a specialized dietician is pivotal to educate patients about the proper use of pancreatic enzymes. However, based on a recent prospective survey in the Netherlands amongst chronic pancreatitis patients, it seems that enzymes are underused and a dietician is seldom consulted. The aim of this study is to assess if there is a difference in efficacy of pancreatic enzymes in a self-dosage regimen after extensive patient-education in comparison to the standard treatment for patients with EPI.

Details

Lead sponsor	Foundation for Liver Research
Phase	Phase 4
Status	COMPLETED
Enrolment	10
Start date	2011-10
Completion	2013-02

Conditions

• Chronic Pancreatitis
• Exocrine Pancreatic Insufficiency

Interventions

• Panzytrat 25.000 FIP-E units of Lipase

Primary outcomes

• Fecal Fat percentage — week 1, 5 and 9
  difference in efficacy measured by the fecal fat content during treatment with pancreatic enzymes in a self-dosage regimen after extensive patient-education in comparison to the standard treatment for patients with EPI due to chronic pancreatitis

Countries

Netherlands