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

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

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

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
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Chicago, Illinois, United States
Site 30
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Maywood, Illinois, United States
Site 21
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Pittsburgh, Pennsylvania, United States
Site 12
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New Orleans, Louisiana, United States
Site 29
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Grand Rapids, Michigan, United States
Site 8
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Cedar Knolls, New Jersey, United States
Site 28
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Kiev, Ukraine
Site 1
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Tupelo, Mississippi, United States
Site 10
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Cincinnati, Ohio, United States
Site 9
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Scottsdale, Arizona, United States
Site 15
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Kansas City, Kansas, United States
Site 7
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Tampa, Florida, United States
Site 14
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Indianapolis, Indiana, United States
Site 2
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Ann Arbor, Michigan, United States
Site 3
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Boston, Massachusetts, United States
Site 11
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Cleveland, Ohio, United States
Site 22
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Bristol, Connecticut, United States
Site 6
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Atlanta, Georgia, United States
Site 20
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Boone, North Carolina, United States
Site 16
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Lexington, Kentucky, United States
Site 5
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St. Louis, Missouri, United States
Site 4
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Rutherford College, North Carolina, United States
Site 27
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Warsaw, Poland
Site 19
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San Juan, Puerto Rico
Site 18
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Richmond, Virginia, United States
Site 25
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Leningrad, Russian Federation
Site 13
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Dallas, Texas, United States
Site 24
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Cape Town, South Africa
Site 23
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Sofia, Bulgaria
Site 26
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Belgrade, Serbia