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Sponsored by: |
Solvay Pharmaceuticals |
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Information provided by: | Solvay Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00630279 |
This study is to estimate the efficacy of a number of doses in patients with pancreatic insufficiency
Condition | Intervention | Phase |
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Pancreatic Exocrine Insufficiency Due to Chronic Pancreatitis |
Drug: Placebo Drug: Recombinant Microbial Lipase SLV339 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | 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 |
Estimated Enrollment: | 80 |
Study Start Date: | February 2008 |
Estimated Study Completion Date: | March 2009 |
Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Placebo Comparator |
Drug: Placebo
Placebo
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2: Experimental |
Drug: Recombinant Microbial Lipase SLV339
oral, 150 mg/d, 7 days treatment
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3: Experimental |
Drug: Recombinant Microbial Lipase SLV339
oral, 300 mg/d, 7 days treatment
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4: Experimental |
Drug: Recombinant Microbial Lipase SLV339
oral, 600 mg/d, 7 days treatment
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Veronika von Hahn | veronika.vonhahn@solvay.com |
Study Director: | Global Clinical Director Solvay | Solvay Pharmaceuticals |
Responsible Party: | Solvay Pharmaceuticals ( Veronika von Hahn ) |
Study ID Numbers: | S339.2.001, 2007-000375-42 |
Study First Received: | February 22, 2008 |
Last Updated: | November 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00630279 |
Health Authority: | United States: Institutional Review Board |
pancreatic exocrine insufficiency chronic pancreatitis |
Digestive System Diseases Pancreatic Diseases Pancreatitis Pancreatitis, Chronic |