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

Study Overview
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Brief Summary
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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.

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

Conditions
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Pancreatectomy, Chronic Pancreatitis, Pancreatic Exocrine Insufficiency

Intervention / Treatment
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* Drug: Pancrelipase delayed release capsule
* Drug: Placebo Comparator


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Drug: Pancrelipase delayed release capsule<br>* 24,000 unit capsule<br>|
| Placebo Comparator: B<br> | Drug: Placebo Comparator<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | End of double-blind period (5-7 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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). | 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). | End of double-period (5-7 days) | 
| Change of Stool Frequency Between Baseline and End of Double-blind (DB) Period | 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). | End of double-period (5-7 days) | 
| Abdominal Pain at the End of the Double-blind Period. | 4- point ordinal scale on this symptom from 0 (No Abdominal pain) to 3 (Severe abdominal pain). | End of double-period (5-7 days) | 
| Stool Consistency at the End of the Double-blind Period | 4- point ordinal scale on this symptom from 0 (Hard) to 3 (Watery). | End of double-period (5-7 days) | 
| Flatulence at the End of Double-blind Period | 4- point ordinal scale on this symptom from 0 (None) to 3 (Severe). | End of double-period (5-7 days) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Pancreatitis, Pancreatectomy, Pancreatic Exocrine Insufficiency