A Study to Investigate the Effect of Delayed Release Pancrelipase on Maldigestion in Patients With Exocrine Pancreatic Insufficiency Due to Chronic Pancreatitis and Pancreatectomy

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This study assessed the effect of pancrelipase delayed release capsules on fat and nitrogen absorption in subjects with PEI due to Chronic Pancreatitis and Pancreatectomy. There was a run-in with a 5-day of single-blind placebo treatment, followed by a 7-day Double-blind period and a 6-month Open-Label Follow-up.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Solvay Pharmaceuticals
• 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) or Clinical signs of severe steatorrhoea that resolved upon administration of pancreatic supplementation.

• Total stool fat > 40 g over 4 days (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:

• Ileus or acute abdomen

• Any type of malignancy involving the digestive tract in the last 5 years

• Presence of pseudo-pancreatic cyst ≥ 4

• Continued excessive intake of alcohol or drug abuse

• Known infection with HIV