Pancreatic Exocrine Insufficiency, Chronic Pancreatitis, Pancreatectomy Clinical Trial
Official title:
A One-year Open-label Study to Assess the Safety of Oral Long-term Use of SA-001 in Patients With Pancreatic Exocrine Insufficiency Caused by Chronic Pancreatitis or by Pancreatectomy
Verified date | July 2011 |
Source | Abbott |
Contact | n/a |
Is FDA regulated | No |
Health authority | Japan: Ministry of Health, Labor and Welfare |
Study type | Interventional |
This study is to evaluate the safety of 3.0 g/day of SA-001 (to be flexibly increased or decreased with the range from 1.5 g/day to 6.0 g/day), which will orally be administered for 52 weeks to patients with pancreatic exocrine insufficiency caused by chronic pancreatitis in the non-compensatory stage or by pancreatectomy.
Status | Completed |
Enrollment | 80 |
Est. completion date | September 2010 |
Est. primary completion date | September 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 20 Years and older |
Eligibility |
Inclusion Criteria Subjects who complete the S245.3.122 clinical study (excluding
discontinued subjects). Exclusion Criteria Subjects who are assessed to be inappropriate for continuing long-term use of SA-001, at the discretion of the investigator or the sub-investigator, because they experienced adverse drug reactions in the S245.3.122 clinical study. |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Japan | Site Reference ID/Investigator# 45211 | Fukuoka | |
Japan | Site Reference ID/Investigator# 45297 | Fukuoka | |
Japan | Site Reference ID/Investigator# 45220 | Hiroshima | |
Japan | Site Reference ID/Investigator# 45279 | Hiroshima | |
Japan | Site Reference ID/Investigator# 45223 | Hokkaido | |
Japan | Site Reference ID/Investigator# 45303 | Hokkaido | |
Japan | Site Reference ID/Investigator# 45091 | Hyogo | |
Japan | Site Reference ID/Investigator# 45110 | Kanagawa | |
Japan | Site Reference ID/Investigator# 45213 | Kanagawa | |
Japan | Site Reference ID/Investigator# 45207 | Kyoto | |
Japan | Site Reference ID/Investigator# 45111 | Miyagi | |
Japan | Site Reference ID/Investigator# 45282 | Miyagi | |
Japan | Site Reference ID/Investigator# 45283 | Nagasaki | |
Japan | Site Reference ID/Investigator# 45106 | Osaka | |
Japan | Site Reference ID/Investigator# 45242 | Sapporo | |
Japan | Site Reference ID/Investigator# 45281 | Tokyo | |
Japan | Site Reference ID/Investigator# 45299 | Yamaguchi |
Lead Sponsor | Collaborator |
---|---|
Abbott |
Japan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety of long-term use of 3.0 g/day SA 001 (12 capsules/day), flexibly increased or decreased within the range of 1.5 g/day SA 001 (6 capsules/day) to 6.0 g/day SA-001 (24 capsules/day) | 52 weeks | Yes | |
Secondary | Efficacy data (nutritional evaluation items) of 3.0 g/day SA-001 (12 capsules/day), flexibly increased or decreased within the range of 1.5 g/day SA 001 (6 capsules/day) to 6.0 g/day SA-001 (24 capsules/day) | 52 weeks | No |