A multi-center, double-blind, parallel-design, randomized, placebo-controlled, dose-ranging study to assess the efficacy and safety of oral recombinant microbial lipase (SLV339) in subjects with pancreatic exocrine insufficiency due to chronic pancreatitis

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2007-000375-42-DK
• Date of registration: 23/10/2007
• Prospective Registration: Yes
• Primary sponsor: Solvay Pharmaceuticals GmbH
• Public title: A multi-center, double-blind, parallel-design, randomized, placebo-controlled, dose-ranging study to assess the efficacy and safety of oral recombinant microbial lipase (SLV339) in subjects with pancreatic exocrine insufficiency due to chronic pancreatitis
• Scientific title: A multi-center, double-blind, parallel-design, randomized, placebo-controlled, dose-ranging study to assess the efficacy and safety of oral recombinant microbial lipase (SLV339) in subjects with pancreatic exocrine insufficiency due to chronic pancreatitis
• Date of first enrolment: 21/02/2008
• Target sample size: 80
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-000375-42
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: yes Other trial design description: Dose-ranging If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no

Countries of recruitment

Czech Republic, Denmark, Hungary, Latvia, Sweden

Key inclusion & exclusion 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 < 80% at Visit 3.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Pancreatic exocrine insufficiency due to chronic pancreatitis
MedDRA version: 9.1 Level: LLT Classification code 10009093 Term: Chronic pancreatitis

Intervention(s)

Product Name: Recombinant microbial lipase
Product Code: SLV339
Pharmaceutical Form: Capsule, hard
Current Sponsor code: SLV339
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use

Primary Outcome(s)

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).

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).

Secondary Objective: Not applicable

Secondary ID(s)

S339.2.001