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Tracking Information | |||||
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First Received Date † | November 16, 2006 | ||||
Last Updated Date | April 28, 2009 | ||||
Start Date † | May 2007 | ||||
Current Primary Outcome Measures † |
Change in CFA from baseline to the end of double-blind treatment [ Time Frame: 7 days after baseline ] [ Designated as safety issue: No ] | ||||
Original Primary Outcome Measures † | Same as current | ||||
Change History | Complete list of historical versions of study NCT00400842 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † |
Stool fat excretion, stool weight, stool frequency, nutritional parameters [ Time Frame: 7 days after baseline ] [ Designated as safety issue: No ] | ||||
Original Secondary Outcome Measures † | Same as current | ||||
Descriptive Information | |||||
Brief Title † | A Study of SA-001 to Treat Pancreatic Exocrine Insufficiency | ||||
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 | ||||
Brief Summary | 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. |
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Detailed Description | |||||
Study Phase | Phase III | ||||
Study Type † | Interventional | ||||
Study Design † | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study | ||||
Condition † |
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Intervention † |
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Study Arms / Comparison Groups | |||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Recruiting | ||||
Enrollment † | 75 | ||||
Estimated Completion Date | November 2009 | ||||
Estimated Primary Completion Date | November 2009 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 20 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† |
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Location Countries † | Japan | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00400842 | ||||
Responsible Party | Toshiaki Yamaguchi, Solvay Pharmaceuticals | ||||
Secondary IDs †† | |||||
Study Sponsor † | Solvay Pharmaceuticals | ||||
Collaborators †† | |||||
Investigators † |
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Information Provided By | Solvay Pharmaceuticals | ||||
Verification Date | April 2009 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |