Dose-ranging Study to Evaluate Efficacy of SLV339 in Pancreatic Exocrine Insufficiency Due to Chronic Pancreatitis

Study Overview
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Brief Summary
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This study is to estimate the efficacy of a number of doses in patients with pancreatic insufficiency

Official Title
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A Multi-center, Single-blind, Parallel-design, Randomized, Placebo-controlled, Dose-ranging Study to Evaluate Oral Recombinant Microbial Lipase Efficacy in Patients With Pancreatic Exocrine Insufficiency Due to Chronic Pancreatitis

Conditions
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Pancreatic Exocrine Insufficiency Due to Chronic Pancreatitis

Intervention / Treatment
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* Drug: Placebo
* Drug: Recombinant Microbial Lipase SLV339
* Drug: Recombinant Microbial Lipase SLV339
* Drug: Recombinant Microbial Lipase SLV339


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject > 18 years; Pancreatic exocrine insufficiency confirmed and documented in medical history by either a pathophysiological direct or indirect pancreatic function test or clinical symptoms of steatorrhea stool fat that resolved or improved substantially upon pancreatic enzyme supplementation; Patients on a stable daily dose of pancreatic enzymes for 3 months; Subjects with CP with or without partial pancreatectomy due to CP, confirmed in medical history by either CT , ERCP, plain film with pancreatic calcifications, ultra-sonography (calcifications, duct dilatation), magnetic resonance pancreatography, endoscope ultrasound, other radiological diagnosis captured by tools such as Cambridge classification and /or histology; CFA < 80% at time of randomization Exclusion Criteria: Evidence of major surgery (except gall bladder removal or appendectomy) or other relevant diseases as revealed by history, physical examination, and laboratory assessments which may interfere with the absorption, distribution, metabolism or elimination of the study drug or constitute a risk factor when taking the study medication; Investigational drug intake within 90 days prior to the pre-assessment visit; Ileus or acute abdomen; Allergic disease such as hypersensitivity pneumonitis, aspergillus mediated asthma or allergic broncho-pulmonary aspergillosis; Stenosis or regurgitation of the esophagus or stomach; Known HIV infection, acute phase of CP

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 |
| --- | --- |
| Placebo Comparator: 1<br> | Drug: Placebo<br>* Placebo<br>|
| Experimental: 2<br> | Drug: Recombinant Microbial Lipase SLV339<br>* oral, 150 mg/d, 7 days treatment<br>|
| Experimental: 3<br> | Drug: Recombinant Microbial Lipase SLV339<br>* oral, 300 mg/d, 7 days treatment<br>|
| Experimental: 4<br> | Drug: Recombinant Microbial Lipase SLV339<br>* oral, 600 mg/d, 7 days treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CFA (Coefficient of Fat Absorption) |  | from baseline to end of 7 days treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CNA, stool fat, stool weight, nutritional parameters, clinical symptomatology |  | from baseline to end of 7 days treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pancreatic exocrine insufficiency, chronic pancreatitis