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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| L | Experimental |
| |
| H | Experimental |
| |
| P | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SA-001 | Drug | 0.25 g of SA-001 pellets/capsule, 12 capsules/day for 7 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in CFA from baseline to the end of double-blind treatment | 7 days after baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Stool fat excretion, stool weight, stool frequency, nutritional parameters | 7 days after baseline |
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Inclusion Criteria
Exclusion Criteria
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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# 59845 | Aichi | Japan | ||||
| Site Reference ID/Investigator# 59933 |
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| SA-001 |
| Drug |
0.25 g of SA-001 pellets/capsule, 6 capsules/day for 7 days |
|
| Placebo | Drug | Placebo |
|
| Aichi |
| Japan |
| Site Reference ID/Investigator# 59928 | Akita | Japan |
| Site Reference ID/Investigator# 59983 | Amori | Japan |
| Site Reference ID/Investigator# 59984 | Amori | Japan |
| Site Reference ID/Investigator# 59569 | Ehime | Japan |
| Site Reference ID/Investigator# 59938 | Ehime | Japan |
| Site Reference ID/Investigator# 59571 | Fukuoka | Japan |
| Site Reference ID/Investigator# 59572 | Fukuoka | Japan |
| Site Reference ID/Investigator# 59812 | Fukuoka | Japan |
| Site Reference ID/Investigator# 59826 | Fukuoka | Japan |
| Site Reference ID/Investigator# 59848 | Fukuoka | Japan |
| Site Reference ID/Investigator# 59922 | Fukuoka | Japan |
| Site Reference ID/Investigator# 59923 | Fukuoka | Japan |
| Site Reference ID/Investigator# 59980 | Fukuoka | Japan |
| Site Reference ID/Investigator# 59932 | Fukushima | Japan |
| Site Reference ID/Investigator# 59935 | Fukushima | Japan |
| Site Reference ID/Investigator# 59930 | Higashiibaraki | Japan |
| Site Reference ID/Investigator# 59929 | Hiroshima | Japan |
| Site Reference ID/Investigator# 59968 | Hiroshima | Japan |
| Site Reference ID/Investigator# 59972 | Hiroshima | Japan |
| Site Reference ID/Investigator# 59827 | Hokkaido | Japan |
| Site Reference ID/Investigator# 59939 | Hokkaido | Japan |
| Site Reference ID/Investigator# 59969 | Hokkaido | Japan |
| Site Reference ID/Investigator# 59974 | Hokkaido | Japan |
| Site Reference ID/Investigator# 59981 | Hokkaido | Japan |
| Site Reference ID/Investigator# 59982 | Hokkaido | Japan |
| Site Reference ID/Investigator# 59576 | Hyōgo | Japan |
| Site Reference ID/Investigator# 59830 | Hyōgo | Japan |
| Site Reference ID/Investigator# 59847 | Hyōgo | Japan |
| Site Reference ID/Investigator# 59907 | Hyōgo | Japan |
| Site Reference ID/Investigator# 59908 | Hyōgo | Japan |
| Site Reference ID/Investigator# 59566 | Ishikawa | Japan |
| Site Reference ID/Investigator# 59911 | Ishikawa | Japan |
| Site Reference ID/Investigator# 59931 | Kagoshima | Japan |
| Site Reference ID/Investigator# 59564 | Kanagawa | Japan |
| Site Reference ID/Investigator# 59565 | Kanagawa | Japan |
| Site Reference ID/Investigator# 59819 | Kanagawa | Japan |
| Site Reference ID/Investigator# 59820 | Kanagawa | Japan |
| Site Reference ID/Investigator# 59823 | Kanagawa | Japan |
| Site Reference ID/Investigator# 59844 | Kanagawa | Japan |
| Site Reference ID/Investigator# 59858 | Kanagawa | Japan |
| Site Reference ID/Investigator# 59570 | Kouchi | Japan |
| Site Reference ID/Investigator# 59574 | Kumamoto | Japan |
| Site Reference ID/Investigator# 59854 | Kurihara | Japan |
| Site Reference ID/Investigator# 59821 | Kyoto | Japan |
| Site Reference ID/Investigator# 59910 | Mie | Japan |
| Site Reference ID/Investigator# 59979 | Mie | Japan |
| Site Reference ID/Investigator# 59849 | Miyagi | Japan |
| Site Reference ID/Investigator# 59851 | Miyagi | Japan |
| Site Reference ID/Investigator# 59857 | Miyagi | Japan |
| Site Reference ID/Investigator# 59975 | Miyagi | Japan |
| Site Reference ID/Investigator# 59976 | Miyagi | Japan |
| Site Reference ID/Investigator# 59977 | Miyagi | Japan |
| Site Reference ID/Investigator# 59937 | Miyazaki | Japan |
| Site Reference ID/Investigator# 59913 | Nagano | Japan |
| Site Reference ID/Investigator# 59825 | Nagasaki | Japan |
| Site Reference ID/Investigator# 59814 | Nagoya | Japan |
| Site Reference ID/Investigator# 59936 | Nagoya | Japan |
| Site Reference ID/Investigator# 59927 | Nara | Japan |
| Site Reference ID/Investigator# 59577 | Okayama | Japan |
| Site Reference ID/Investigator# 59567 | Osaka | Japan |
| Site Reference ID/Investigator# 59568 | Osaka | Japan |
| Site Reference ID/Investigator# 59575 | Osaka | Japan |
| Site Reference ID/Investigator# 59815 | Osaka | Japan |
| Site Reference ID/Investigator# 59822 | Osaka | Japan |
| Site Reference ID/Investigator# 59824 | Osaka | Japan |
| Site Reference ID/Investigator# 59829 | Osaka | Japan |
| Site Reference ID/Investigator# 59912 | Osaka | Japan |
| Site Reference ID/Investigator# 59914 | Osaka | Japan |
| Site Reference ID/Investigator# 59915 | Osaka | Japan |
| Site Reference ID/Investigator# 59934 | Osaka | Japan |
| Site Reference ID/Investigator# 59940 | Osaka | Japan |
| Site Reference ID/Investigator# 59573 | Saga | Japan |
| Site Reference ID/Investigator# 59556 | Saitama | Japan |
| Site Reference ID/Investigator# 59925 | Saitama | Japan |
| Site Reference ID/Investigator# 59555 | Sapporo | Japan |
| Site Reference ID/Investigator# 59810 | Shiga | Japan |
| Site Reference ID/Investigator# 59852 | Shimane | Japan |
| Site Reference ID/Investigator# 59855 | Suwa | Japan |
| Site Reference ID/Investigator# 59909 | Tochigi | Japan |
| Site Reference ID/Investigator# 59557 | Tokyo | Japan |
| Site Reference ID/Investigator# 59813 | Tokyo | Japan |
| Site Reference ID/Investigator# 59818 | Tokyo | Japan |
| Site Reference ID/Investigator# 59850 | Tokyo | Japan |
| Site Reference ID/Investigator# 59859 | Tokyo | Japan |
| Site Reference ID/Investigator# 59971 | Tokyo | Japan |
| Site Reference ID/Investigator# 59973 | Tokyo | Japan |
| Site Reference ID/Investigator# 59978 | Tokyo | Japan |
| Site Reference ID/Investigator# 59816 | Toyama | Japan |
| Site Reference ID/Investigator# 59970 | Toyama | Japan |
| Site Reference ID/Investigator# 59811 | Wakayama | Japan |
| Site Reference ID/Investigator# 59856 | Yamagata | Japan |
| Site Reference ID/Investigator# 59926 | Yamagata | Japan |
| Site Reference ID/Investigator# 59817 | Yamaguchi | Japan |
| Site Reference ID/Investigator# 59924 | Yamaguchi | Japan |
| Site Reference ID/Investigator# 59846 | Yamanashi | Japan |
| Site Reference ID/Investigator# 59828 | Yokohama | 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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