A Study of SA-001 to Treat Pancreatic Exocrine Insufficiency
- Conditions
- Exocrine Pancreatic Insufficiency, Chronic Pancreatitis
- Interventions
- Drug: Placebo
- Registration Number
- NCT00400842
- Lead Sponsor
- Abbott
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 274
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description L SA-001 - P Placebo - H SA-001 -
- Primary Outcome Measures
Name Time Method Change in CFA from baseline to the end of double-blind treatment 7 days after baseline
- Secondary Outcome Measures
Name Time Method Stool fat excretion, stool weight, stool frequency, nutritional parameters 7 days after baseline
Trial Locations
- Locations (98)
Site Reference ID/Investigator# 59984
🇯🇵Amori, Japan
Site Reference ID/Investigator# 59572
🇯🇵Fukuoka, Japan
Site Reference ID/Investigator# 59845
🇯🇵Aichi, Japan
Site Reference ID/Investigator# 59570
🇯🇵Kouchi, Japan
Site Reference ID/Investigator# 59927
🇯🇵Nara, Japan
Site Reference ID/Investigator# 59567
🇯🇵Osaka, Japan
Site Reference ID/Investigator# 59568
🇯🇵Osaka, Japan
Site Reference ID/Investigator# 59577
🇯🇵Okayama, Japan
Site Reference ID/Investigator# 59971
🇯🇵Tokyo, Japan
Site Reference ID/Investigator# 59983
🇯🇵Amori, Japan
Site Reference ID/Investigator# 59933
🇯🇵Aichi, Japan
Site Reference ID/Investigator# 59569
🇯🇵Ehime, Japan
Site Reference ID/Investigator# 59928
🇯🇵Akita, Japan
Site Reference ID/Investigator# 59812
🇯🇵Fukuoka, Japan
Site Reference ID/Investigator# 59571
🇯🇵Fukuoka, Japan
Site Reference ID/Investigator# 59848
🇯🇵Fukuoka, Japan
Site Reference ID/Investigator# 59938
🇯🇵Ehime, Japan
Site Reference ID/Investigator# 59922
🇯🇵Fukuoka, Japan
Site Reference ID/Investigator# 59932
🇯🇵Fukushima, Japan
Site Reference ID/Investigator# 59935
🇯🇵Fukushima, Japan
Site Reference ID/Investigator# 59929
🇯🇵Hiroshima, Japan
Site Reference ID/Investigator# 59826
🇯🇵Fukuoka, Japan
Site Reference ID/Investigator# 59923
🇯🇵Fukuoka, Japan
Site Reference ID/Investigator# 59930
🇯🇵Higashiibaraki, Japan
Site Reference ID/Investigator# 59968
🇯🇵Hiroshima, Japan
Site Reference ID/Investigator# 59827
🇯🇵Hokkaido, Japan
Site Reference ID/Investigator# 59982
🇯🇵Hokkaido, Japan
Site Reference ID/Investigator# 59907
🇯🇵Hyogo, Japan
Site Reference ID/Investigator# 59980
🇯🇵Fukuoka, Japan
Site Reference ID/Investigator# 59972
🇯🇵Hiroshima, 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# 59576
🇯🇵Hyogo, Japan
Site Reference ID/Investigator# 59830
🇯🇵Hyogo, Japan
Site Reference ID/Investigator# 59908
🇯🇵Hyogo, Japan
Site Reference ID/Investigator# 59911
🇯🇵Ishikawa, Japan
Site Reference ID/Investigator# 59847
🇯🇵Hyogo, Japan
Site Reference ID/Investigator# 59566
🇯🇵Ishikawa, Japan
Site Reference ID/Investigator# 59564
🇯🇵Kanagawa, Japan
Site Reference ID/Investigator# 59931
🇯🇵Kagoshima, 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# 59821
🇯🇵Kyoto, 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# 59574
🇯🇵Kumamoto, Japan
Site Reference ID/Investigator# 59910
🇯🇵MIE, Japan
Site Reference ID/Investigator# 59854
🇯🇵Kurihara, Japan
Site Reference ID/Investigator# 59979
🇯🇵Mie, Japan
Site Reference ID/Investigator# 59851
🇯🇵Miyagi, Japan
Site Reference ID/Investigator# 59857
🇯🇵Miyagi, Japan
Site Reference ID/Investigator# 59849
🇯🇵Miyagi, Japan
Site Reference ID/Investigator# 59975
🇯🇵Miyagi, Japan
Site Reference ID/Investigator# 59937
🇯🇵Miyazaki, Japan
Site Reference ID/Investigator# 59977
🇯🇵Miyagi, Japan
Site Reference ID/Investigator# 59913
🇯🇵Nagano, Japan
Site Reference ID/Investigator# 59976
🇯🇵Miyagi, Japan
Site Reference ID/Investigator# 59825
🇯🇵Nagasaki, Japan
Site Reference ID/Investigator# 59936
🇯🇵Nagoya-city, Japan
Site Reference ID/Investigator# 59814
🇯🇵Nagoya, 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# 59852
🇯🇵Shimane, Japan
Site Reference ID/Investigator# 59810
🇯🇵Shiga, Japan
Site Reference ID/Investigator# 59914
🇯🇵Osaka, Japan
Site Reference ID/Investigator# 59912
🇯🇵Osaka, Japan
Site Reference ID/Investigator# 59829
🇯🇵Osaka, Japan
Site Reference ID/Investigator# 59915
🇯🇵Osaka, Japan
Site Reference ID/Investigator# 59940
🇯🇵Osaka, Japan
Site Reference ID/Investigator# 59556
🇯🇵Saitama, Japan
Site Reference ID/Investigator# 59934
🇯🇵Osaka, Japan
Site Reference ID/Investigator# 59573
🇯🇵Saga, Japan
Site Reference ID/Investigator# 59555
🇯🇵Sapporo, Japan
Site Reference ID/Investigator# 59855
🇯🇵Suwa, Japan
Site Reference ID/Investigator# 59925
🇯🇵Saitama, 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# 59859
🇯🇵Tokyo, Japan
Site Reference ID/Investigator# 59850
🇯🇵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# 59811
🇯🇵Wakayama, Japan
Site Reference ID/Investigator# 59970
🇯🇵Toyama, Japan
Site Reference ID/Investigator# 59856
🇯🇵Yamagata, Japan
Site Reference ID/Investigator# 59828
🇯🇵Yokohama, 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