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

Solvay

Status and phase: Completed; Phase 3

Conditions: Chronic Pancreatitis; Pancreatectomy; Pancreatic Exocrine Insufficiency

Treatments: Drug: Placebo Comparator; Drug: Pancrelipase delayed release capsule

Study type: Interventional

Funder types: Industry

Identifiers

NCT00414908

2004-000227-15

S245.3.124

Details and patient eligibility

About

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.

Enrollment: 52 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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52 participants in 2 patient groups, including a placebo group

A

Experimental group

Treatment:

Drug: Pancrelipase delayed release capsule

B

Placebo Comparator group

Treatment:

Drug: Placebo Comparator