Pancreatic exocrine insufficiency due to chronic pancreatitis MedDRA version: 9.1 Level: LLT Classification code 10009093 Term: Chronic pancreatitis
Conditions
Interventions
Product Name: Recombinant microbial lipase
Product Code: SLV339
Pharmaceutical Form: Capsule, hard
Current Sponsor code: SLV339
Concentration unit: mg milligram(s)
Concentration type: equal
Concentrat
Sponsors
Solvay Pharmaceuticals GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion Criteria at Visit 1 1. Signed informed consent. 2. Subject must be = 18 years and be of either sex. 3. 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 administration of pancreatic enzyme supplementation. 4. Subjects are clinically stable and are on a stable daily dose of pancreatic enzyme supplementation for at least 3 months before the start of the study. 5. Subjects with CP with or without partial pancreatectomy due to underlying CP; CP confirmed and documented in medical history by either computed tomography, endoscope retrograde cholangiopancreaticography, plain film with pancreatic calcifications, ultra-sonography (calcifications, duct dilatation), magnetic resonance pancreatography, endoscope ultrasound, other radiological diagnosis captured by tools such as Cambridge classification3 and /or histology. 6. Females of non-childbearing potential (i.e., sterilized via hysterectomy or bilateral tubal ligation or at least 1 year postmenopausal) or if of childbearing potential must agree to practice effective barrier contraceptive methods, use an intrauterine device 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. Inclusion Criterion at Visit 3 1. Coefficient of fat absorption during the untreated part of the run-in period confirmed as =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion Criteria at Visit 1 1. Evidence of cardiovascular, gastrointestinal/ hepatic (except CP or pancreatectomy), renal, neurological/ psychiatric, respiratory, urogenital, hematological/ immunologic, head, ears, eyes, nose or throat, dermatologic/ connective tissue, musculoskeletal, metabolic/ nutritional, drug hypersensitivity, allergy, endocrine (except diabetes mellitus), major surgery (except gall bladder removal or appendectomy) or other relevant diseases as revealed by history, physical examination, and laboratory assessments which might limit participation or completion of the study. 2. Investigational drug intake within 90 days prior to the pre-assessment visit. 3. Gastrointestinal stricture, ileus or acute abdomen. 4. Any type of malignancy involving the GI tract in the last 5 years. 5. Current excessive intake of alcohol or drug abuse. 6. Allergic disease such as hypersensitivity pneumonitis, Aspergillus mediated asthma or allergic broncho-pulmonary aspergillosis. 7 Allergic reaction to Aspergillus fumigatus (FastCheckPOC®).4 8. Suspected non-compliance or non-cooperation. 9. Stenosis of the esophagus or stomach. 10. Mental disability or any lack of fitness that in the investigator’s opinion precludes the subject’s participation in the study. 11. Human immunodeficiency virus infection in medical history. 12. Subjects requiring treatment with non-permitted medication or exceeding the treatment limits of permitted medication. 13. Subjects in acute phase of pancreatitis. 14. Subjects with the following abnormalities of liver function tests at visit 1 will be excluded: X3 elevation alanine transaminase (ALT) or aspartate transaminase (AST), X2 elevation of bilirubin or subjects with decompensated liver disease. 15. Subjects with impaired renal function: creatinine = 1.7 mg/dl. 16. Subjects with coeliac disease, total gastrectomy, Crohn’s disease and small bowel surgery.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: This study is designed to estimate the dose-response curve for short term efficacy and safety of recombinant microbial lipase (SLV339) in subjects with maldigestion of lipids due to pancreatic exocrine insufficiency (PEI) suffering from chronic pancreatitis (CP).;Secondary Objective: Not applicable;Primary end point(s): Criteria for Evaluation: Efficacy: Efficacy parameters will be CFA, CNA, stool fat, stool fat concentration, stool nitrogen, stool weight, nutritional protein and fat intake and clinical symptomatology (stool frequency, stool consistency, abdominal pain, and flatulence). Safety: Safety parameters will include vital signs, physical examination, laboratory and nutritional examinations (triglycerides, cholesterol, low-density-lipoproteins, high-density-lipoproteins, retinol-binding protein, pre-albumin, albumin, transferrin, vitamin E), ADA measurements and adverse events (AEs). | — |
Countries
Czech Republic, Denmark, Hungary, Latvia, Sweden
Outcome results
None listed