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Sponsored by: |
Solvay Pharmaceuticals |
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Information provided by: | Solvay Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00414908 |
This study will assess the effect of pancrelipase delayed release capsules on fat and nitrogen absorption in subjects with PEI due to Chronic Pancreatitis. The QoL will also be assessed. Safety data will be generated in the open-label extension period.
Condition | Intervention | Phase |
---|---|---|
Chronic Pancreatitis Pancreatectomy Pancreatic Exocrine Insufficiency |
Drug: Pancrelipase delayed release capsule Drug: Placebo Comparator |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | A Study to Investigate the Effect of Delayed Release Pancrelipase on Maldigestion in Patients With Exocrine Pancreatic Insufficiency Due to Chronic Pancreatitis and Pancreatectomy |
Estimated Enrollment: | 52 |
Study Start Date: | October 2007 |
Estimated Study Completion Date: | November 2008 |
Estimated Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
A: Experimental |
Drug: Pancrelipase delayed release capsule
24,000 unit capsule
|
B: Placebo Comparator |
Drug: Placebo Comparator
Placebo
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Pancreatic exocrine insufficiency has to be proven (in medical history) by the following criteria:
Exclusion Criteria:
Study Director: | Global Clinical Director Solvay | Solvay Pharmaceuticals |
Responsible Party: | Solvay Pharmaceuticals ( Gregor Eibes ) |
Study ID Numbers: | S245.3.124, 2004-000227-15 |
Study First Received: | December 21, 2006 |
Last Updated: | November 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00414908 |
Health Authority: | United States: Food and Drug Administration |
Chronic Pancreatitis Pancreatectomy Pancreatic Exocrine Insufficiency |
Digestive System Diseases Pancreatic Diseases Pancrelipase |
Exocrine Pancreatic Insufficiency Pancreatitis Pancreatitis, Chronic |
Therapeutic Uses Gastrointestinal Agents Pharmacologic Actions |