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

Phase 3

Completed

• Conditions: Chronic Pancreatitis; Pancreatectomy; Pancreatic Exocrine Insufficiency
• Interventions: Drug: Pancrelipase delayed release capsule; Drug: Placebo Comparator

• Registration Number: NCT00414908
• Lead Sponsor: Solvay Pharmaceuticals

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-12-21
• Study First Submitted QC: 2006-12-21
• Study First Posted: 2006-12-22
• Study Start: 2007-10
• Primary Completion: 2008-08
• Results First Submitted: 2009-08-07
• Results First Submitted QC: 2009-08-07
• Results First Posted: 2009-09-16
• Study Completion: 2009-12
• Status Verified: 2011-08
• Last Update Submitted: 2011-08-08
• Last Update Posted: 2011-08-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Pancrelipase delayed release capsule	-
B	Placebo Comparator	-

Primary Outcome Measures

Name	Time	Method
Change of Coefficient of Fat Absorption (CFA) (%) Between Baseline and End of Double-blind (DB) Period.	End of double-blind period (5-7 days)	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).

Secondary Outcome Measures

Name	Time	Method
Change of Coefficient of Nitrogen Absorption (CNA) (%) Between Baseline and End of Double-blind (DB) Period.	End of double-blind period (5-7 days)	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).
Change From Baseline of Stool Fat (g) Between Baseline and End of Double-blind (DB) Period.	End of double-blind period (5-7 days)	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).
Change From Baseline of Stool Nitrogen (g) Between Baseline and End of Double-blind (DB) Period.	End of double-period (5-7 days)	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).
Change of Stool Frequency Between Baseline and End of Double-blind (DB) Period	End of double-period (5-7 days)	Stool frequency is the average of the daily number of stools recorded during the treatment period. Lower values indicate a better response. Change was calculated as (DB stool frequency - Baseline Stool frequency).
Abdominal Pain at the End of the Double-blind Period.	End of double-period (5-7 days)	4- point ordinal scale on this symptom from 0 (No Abdominal pain) to 3 (Severe abdominal pain).
Stool Consistency at the End of the Double-blind Period	End of double-period (5-7 days)	4- point ordinal scale on this symptom from 0 (Hard) to 3 (Watery).
Flatulence at the End of Double-blind Period	End of double-period (5-7 days)	4- point ordinal scale on this symptom from 0 (None) to 3 (Severe).

Trial Locations

Locations (30)

Site 17; 🇺🇸 Chicago, Illinois, United States

Site 30; 🇺🇸 Maywood, Illinois, United States

Site 21; 🇺🇸 Pittsburgh, Pennsylvania, United States

Site 12; 🇺🇸 New Orleans, Louisiana, United States

Site 29; 🇺🇸 Grand Rapids, Michigan, United States

Site 8; 🇺🇸 Cedar Knolls, New Jersey, United States

Site 28; 🇺🇦 Kiev, Ukraine

Site 1; 🇺🇸 Tupelo, Mississippi, United States

Site 10; 🇺🇸 Cincinnati, Ohio, United States

Site 9; 🇺🇸 Scottsdale, Arizona, United States

Site 15; 🇺🇸 Kansas City, Kansas, United States

Site 7; 🇺🇸 Tampa, Florida, United States

Site 14; 🇺🇸 Indianapolis, Indiana, United States

Site 2; 🇺🇸 Ann Arbor, Michigan, United States

Site 3; 🇺🇸 Boston, Massachusetts, United States

Site 11; 🇺🇸 Cleveland, Ohio, United States

Site 22; 🇺🇸 Bristol, Connecticut, United States

Site 6; 🇺🇸 Atlanta, Georgia, United States

Site 20; 🇺🇸 Boone, North Carolina, United States

Site 16; 🇺🇸 Lexington, Kentucky, United States

Site 5; 🇺🇸 St. Louis, Missouri, United States

Site 4; 🇺🇸 Rutherford College, North Carolina, United States

Site 27; 🇵🇱 Warsaw, Poland

Site 19; 🇵🇷 San Juan, Puerto Rico

Site 18; 🇺🇸 Richmond, Virginia, United States

Site 25; 🇷🇺 Leningrad, Russian Federation

Site 13; 🇺🇸 Dallas, Texas, United States

Site 24; 🇿🇦 Cape Town, South Africa

Site 23; 🇧🇬 Sofia, Bulgaria

Site 26; 🇷🇸 Belgrade, Serbia