Creon 40,000 for Treatment of PEI (Pancreatic Exocrine Insufficiency) Due to Chronic Pancreatitis

Study Overview
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Brief Summary
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This study will provide efficacy data for Creon 40,000 in CP subjects as well as long-term safety data. During the long-term treatment with Creon 40,000 nutritional parameters will be assessed and correlated with CFA.

Official Title
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A One Week Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multi-Center Study With Creon 40,000 MMS in Subjects With Pancreatic Exocrine Insufficiency Due to Chronic Pancreatitis, Followed by an Open-Label Long-Term Extension

Conditions
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Pancreatic Insufficiency

Intervention / Treatment
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* Drug: Pancreatin
* Drug: Placebo


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 a pancreatic function test Chronic pancreatitis has to be proven (in medical history) by CT, ERCP, plain film with pancreatic calcifications, ultrasonography (calcifications,duct dilatation) and /or histology Females must be non-lactating and either be of non-childbearing potential or if of childbearing potential, agree to practice effective barrier contraceptive methods, use an intrauterine device (IUD) or use birth control pills or equivalent injectable contraceptive. The subject must have been practicing the selected method of birth control for at least 3 months prior to Visit 1 (Day -14). Subjects with a pathological stool fat during run in period (> 10g/24 h) Exclusion Criteria Ileus or acute abdomen Any type of malignancy involving the digestive tract in the last 5 years Presence of pseudo pancreatic cysts >= 4 cm Current excessive intake of alcohol or drug abuse Hypersensitivity vs porcine proteins / pancreatin

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: 1<br> | Drug: Pancreatin<br>* Pancreatin with 40000 lipase units per capsule, 2 capsules per main meal (3 main meals) plus 1 capsule per snack (2-3 snacks)<br>|
| Placebo Comparator: 2<br> | Drug: Placebo<br>* placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in CFA from baseline to the end of double blind treatment |  | 7 days after baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CNA, stool fat, stool weight, nutritional, clinical symptomatology, SF-36, BMI |  | 7 days after baseline, and end of open-label period (1 year of open label treatment) | 

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