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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SA-001 | Drug | 0.25 g of SA-001 pellets/capsule, 12 capsules/day for 52 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Toshiaki Yamaguchi, BS Pharm | Abbott | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Reference ID/Investigator# 45211 | Fukuoka | Japan | ||||
| Site Reference ID/Investigator# 45297 |
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| 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 | Hyōgo | 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 | Japan |
| ID | Term |
|---|---|
| D010188 | Exocrine Pancreatic Insufficiency |
| D050500 | Pancreatitis, Chronic |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D010195 | Pancreatitis |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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