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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00400842 |
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Date of registration:
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16/11/2006 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Study of SA-001 to Treat Pancreatic Exocrine Insufficiency
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Scientific title:
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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 |
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Date of first enrolment:
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May 2007 |
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Target sample size:
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274 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00400842 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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Phase:
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Phase 3
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Countries of recruitment
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Japan
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Contacts
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Name:
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Toshiaki Yamaguchi, BS Pharm |
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Address:
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Telephone:
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Email:
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Affiliation:
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Abbott |
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Key inclusion & exclusion criteria
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Inclusion Criteria
- Subjects with chronic pancreatitis in the non-compensatory stage or pancreatectomy
- Subjects whose CFA is 80% or less
- Subjects who are able to be hospitalized
Exclusion Criteria
- Subjects who are judged to be difficult to have at least 40 g/day of fat intake
during course of the study
- Subjects who have a known allergy to porcine protein and/or any component of
digestive enzyme preparations
- Subjects who are in the acute phase of chronic pancreatitis
- Subjects with non-pancreatic malabsorption syndrome
- Subjects with acute pancreatitis or ileus
Age minimum:
20 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Exocrine Pancreatic Insufficiency, Chronic Pancreatitis
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Intervention(s)
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Drug: Placebo
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Drug: SA-001
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Primary Outcome(s)
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Change in CFA from baseline to the end of double-blind treatment
[Time Frame: 7 days after baseline]
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Secondary Outcome(s)
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Stool fat excretion, stool weight, stool frequency, nutritional parameters
[Time Frame: 7 days after baseline]
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Secondary ID(s)
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S245.3.122
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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