Exocrine Pancreatic Insufficiency, Chronic Pancreatitis Clinical Trial
Official title:
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
| 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 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.
| Status | Completed |
| Enrollment | 274 |
| Est. completion date | August 2009 |
| Est. primary completion date | August 2009 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 20 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Japan | Site Reference ID/Investigator# 59845 | Aichi | |
| Japan | Site Reference ID/Investigator# 59933 | 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 | Hyogo | |
| Japan | Site Reference ID/Investigator# 59830 | Hyogo | |
| Japan | Site Reference ID/Investigator# 59847 | Hyogo | |
| Japan | Site Reference ID/Investigator# 59907 | Hyogo | |
| Japan | Site Reference ID/Investigator# 59908 | Hyogo | |
| 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-city | |
| 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 |
| Lead Sponsor | Collaborator |
|---|---|
| Abbott |
Japan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change in CFA from baseline to the end of double-blind treatment | 7 days after baseline | No | |
| Secondary | Stool fat excretion, stool weight, stool frequency, nutritional parameters | 7 days after baseline | No |