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Sponsored by: |
Solvay Pharmaceuticals |
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Information provided by: | Solvay Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00400842 |
This study is to verify the efficacy of 3.0 g/day of SA-001 in patients with pancreatic exocrine insufficiency caused by chronic pancreatitis in the non-compensatory stage or by pancreatectomy as compared with placebo under a double-blind design using the change in a coefficient of fat absorption as a primary endpoint.
Condition | Intervention | Phase |
---|---|---|
Exocrine Pancreatic Insufficiency Chronic Pancreatitis |
Drug: SA-001 Drug: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Double-Blind, Placebo-Controlled, Parallel-Group, Comparative Study to Confirm the Safety and Efficacy of Oral 1.5 g/Day and 3.0 g/Day of SA-001 in Patients With Pancreatic Exocrine Insufficiency Caused by Chronic Pancreatitis or by Pancreatectomy |
Estimated Enrollment: | 75 |
Study Start Date: | May 2007 |
Estimated Study Completion Date: | February 2009 |
Estimated Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
L: Experimental |
Drug: SA-001
0.25 g of SA-001 pellets/capsule, 12 capsules/day for 7 days
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H: Experimental |
Drug: SA-001
0.25 g of SA-001 pellets/capsule, 6 capsules/day for 7 days
|
P: Placebo Comparator |
Drug: Placebo
Placebo
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Ages Eligible for Study: | 20 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Toshiaki Yamaguchi | Toshiaki.Yamaguchi@solvay.com |
Study Director: | Global Clinical Director Solvay | Solvay Pharmaceuticals |
Responsible Party: | Solvay Pharmaceuticals ( Toshiaki Yamaguchi ) |
Study ID Numbers: | S245.3.122 |
Study First Received: | November 16, 2006 |
Last Updated: | November 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00400842 |
Health Authority: | Japan: Ministry of Health, Labor and Welfare |
SA-001 Pancreatic Exocrine Insufficiency Pancreatectomy |
Digestive System Diseases Pancreatic Diseases Exocrine Pancreatic Insufficiency Pancreatitis Pancreatitis, Chronic |