Dose-ranging Study to Evaluate Efficacy of SLV339 in Pancreatic Exocrine Insufficiency Due to Chronic Pancreatitis
NCT00630279 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 56
Last updated 2009-08-06
Summary
This study is to estimate the efficacy of a number of doses in patients with pancreatic insufficiency
Conditions
- Pancreatic Exocrine Insufficiency Due to Chronic Pancreatitis
Interventions
- DRUG
-
Placebo
- DRUG
-
Recombinant Microbial Lipase SLV339
oral, 150 mg/d, 7 days treatment
- DRUG
-
Recombinant Microbial Lipase SLV339
oral, 300 mg/d, 7 days treatment
- DRUG
-
Recombinant Microbial Lipase SLV339
oral, 600 mg/d, 7 days treatment
Sponsors & Collaborators
-
Solvay Pharmaceuticals
lead INDUSTRY
Principal Investigators
-
Global Clinical Director Solvay · Solvay Pharmaceuticals
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2008-02-29
- Primary Completion
- 2009-03-31
- Completion
- 2009-03-31
Countries
- Czechia
- Denmark
- Hungary
- Latvia
- Poland
- Russia
- Sweden
Study Locations
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