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 Pharmaceuticals52 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Chronic Pancreatitis Pancreatectomy Pancreatic Exocrine Insufficiency

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (30)

Site 9

Scottsdale, Arizona, United States

Site 22

Bristol, Connecticut, United States

Site 7

Tampa, Florida, United States

Site 6

Atlanta, Georgia, United States

Site 17

Chicago, Illinois, United States

Site 30

Maywood, Illinois, United States

Site 14

Indianapolis, Indiana, United States

Site 15

Kansas City, Kansas, United States

Site 16

Lexington, Kentucky, United States

Site 12

New Orleans, Louisiana, United States

...and 20 more locations

Outcomes

Primary Outcomes

Change of Coefficient of Fat Absorption (CFA) (%) Between Baseline and End of Double-blind (DB) Period.

The CFA is calculated from fat intake and fat excretion : 100\*\[fat intake-fat excretion\]/fat intake. Higher values indicated a better response. Change is calculated as (DB CFA-Baseline CFA).

Time frame: End of double-blind period (5-7 days)

Secondary Outcomes

Change of Coefficient of Nitrogen Absorption (CNA) (%) Between Baseline and End of Double-blind (DB) Period.

The CNA is calculated from nitrogen intake and nitrogen excretion : 100\*\[nitrogen intake-nitrogen excretion\]/nitrogen intake. Higher values indicated a better response. Change is calculated as (DB CNA-Baseline CNA).

Time frame: End of double-blind period (5-7 days)

Change From Baseline of Stool Fat (g) Between Baseline and End of Double-blind (DB) Period.

Total amount of fat excreted during the stool collection period. Lower values indicate a better response. Change was calculated as (DB Stool fat - Baseline stool fat).

Time frame: End of double-blind period (5-7 days)

Change From Baseline of Stool Nitrogen (g) Between Baseline and End of Double-blind (DB) Period.

Total amount of nitrogen excreted during the stool collection period. Lower values indicate a better response. Change was calculated as (DB Stool nitrogen - Baseline stool nitrogen).