Clinical trial NCT00400842: A Study of SA-001 to Treat Pancreatic Exocrine Insufficiency
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Exocrine Pancreatic Insufficiency, Chronic Pancreatitis
Keywords: SA-001
Pancreatic Exocrine Insufficiency
Pancreatectomy
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2006-11-17
Enrollment: 274
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in CFA from baseline to the end of double-blind treatment
timeFrame: 7 days after baseline
Secondary outcomes:
measure: Stool fat excretion, stool weight, stool frequency, nutritional parameters
timeFrame: 7 days after baseline
Other outcomes:
Locations:
city: Aichi
country: Japan
facility: Site Reference ID/Investigator# 59845
city: Aichi
country: Japan
facility: Site Reference ID/Investigator# 59933
city: Akita
country: Japan
facility: Site Reference ID/Investigator# 59928
city: Amori
country: Japan
facility: Site Reference ID/Investigator# 59983
city: Amori
country: Japan
facility: Site Reference ID/Investigator# 59984
city: Ehime
country: Japan
facility: Site Reference ID/Investigator# 59569
city: Ehime
country: Japan
facility: Site Reference ID/Investigator# 59938
city: Fukuoka
country: Japan
facility: Site Reference ID/Investigator# 59571
city: Fukuoka
country: Japan
facility: Site Reference ID/Investigator# 59572
city: Fukuoka
country: Japan
facility: Site Reference ID/Investigator# 59812
city: Fukuoka
country: Japan
facility: Site Reference ID/Investigator# 59826
city: Fukuoka
country: Japan
facility: Site Reference ID/Investigator# 59848
city: Fukuoka
country: Japan
facility: Site Reference ID/Investigator# 59922
city: Fukuoka
country: Japan
facility: Site Reference ID/Investigator# 59923
city: Fukuoka
country: Japan
facility: Site Reference ID/Investigator# 59980
city: Fukushima
country: Japan
facility: Site Reference ID/Investigator# 59932
city: Fukushima
country: Japan
facility: Site Reference ID/Investigator# 59935
city: Higashiibaraki
country: Japan
facility: Site Reference ID/Investigator# 59930
city: Hiroshima
country: Japan
facility: Site Reference ID/Investigator# 59929
city: Hiroshima
country: Japan
facility: Site Reference ID/Investigator# 59968
city: Hiroshima
country: Japan
facility: Site Reference ID/Investigator# 59972
city: Hokkaido
country: Japan
facility: Site Reference ID/Investigator# 59827
city: Hokkaido
country: Japan
facility: Site Reference ID/Investigator# 59939
city: Hokkaido
country: Japan
facility: Site Reference ID/Investigator# 59969
city: Hokkaido
country: Japan
facility: Site Reference ID/Investigator# 59974
city: Hokkaido
country: Japan
facility: Site Reference ID/Investigator# 59981
city: Hokkaido
country: Japan
facility: Site Reference ID/Investigator# 59982
city: Hyogo
country: Japan
facility: Site Reference ID/Investigator# 59576
city: Hyogo
country: Japan
facility: Site Reference ID/Investigator# 59830
city: Hyogo
country: Japan
facility: Site Reference ID/Investigator# 59847
city: Hyogo
country: Japan
facility: Site Reference ID/Investigator# 59907
city: Hyogo
country: Japan
facility: Site Reference ID/Investigator# 59908
city: Ishikawa
country: Japan
facility: Site Reference ID/Investigator# 59566
city: Ishikawa
country: Japan
facility: Site Reference ID/Investigator# 59911
city: Kagoshima
country: Japan
facility: Site Reference ID/Investigator# 59931
city: Kanagawa
country: Japan
facility: Site Reference ID/Investigator# 59564
city: Kanagawa
country: Japan
facility: Site Reference ID/Investigator# 59565
city: Kanagawa
country: Japan
facility: Site Reference ID/Investigator# 59819
city: Kanagawa
country: Japan
facility: Site Reference ID/Investigator# 59820
city: Kanagawa
country: Japan
facility: Site Reference ID/Investigator# 59823
city: Kanagawa
country: Japan
facility: Site Reference ID/Investigator# 59844
city: Kanagawa
country: Japan
facility: Site Reference ID/Investigator# 59858
city: Kouchi
country: Japan
facility: Site Reference ID/Investigator# 59570
city: Kumamoto
country: Japan
facility: Site Reference ID/Investigator# 59574
city: Kurihara
country: Japan
facility: Site Reference ID/Investigator# 59854
city: Kyoto
country: Japan
facility: Site Reference ID/Investigator# 59821
city: MIE
country: Japan
facility: Site Reference ID/Investigator# 59910
city: Mie
country: Japan
facility: Site Reference ID/Investigator# 59979
city: Miyagi
country: Japan
facility: Site Reference ID/Investigator# 59849
city: Miyagi
country: Japan
facility: Site Reference ID/Investigator# 59851
city: Miyagi
country: Japan
facility: Site Reference ID/Investigator# 59857
city: Miyagi
country: Japan
facility: Site Reference ID/Investigator# 59975
city: Miyagi
country: Japan
facility: Site Reference ID/Investigator# 59976
city: Miyagi
country: Japan
facility: Site Reference ID/Investigator# 59977
city: Miyazaki
country: Japan
facility: Site Reference ID/Investigator# 59937
city: Nagano
country: Japan
facility: Site Reference ID/Investigator# 59913
city: Nagasaki
country: Japan
facility: Site Reference ID/Investigator# 59825
city: Nagoya-city
country: Japan
facility: Site Reference ID/Investigator# 59936
city: Nagoya
country: Japan
facility: Site Reference ID/Investigator# 59814
city: Nara
country: Japan
facility: Site Reference ID/Investigator# 59927
city: Okayama
country: Japan
facility: Site Reference ID/Investigator# 59577
city: Osaka
country: Japan
facility: Site Reference ID/Investigator# 59567
city: Osaka
country: Japan
facility: Site Reference ID/Investigator# 59568
city: Osaka
country: Japan
facility: Site Reference ID/Investigator# 59575
city: Osaka
country: Japan
facility: Site Reference ID/Investigator# 59815
city: Osaka
country: Japan
facility: Site Reference ID/Investigator# 59822
city: Osaka
country: Japan
facility: Site Reference ID/Investigator# 59824
city: Osaka
country: Japan
facility: Site Reference ID/Investigator# 59829
city: Osaka
country: Japan
facility: Site Reference ID/Investigator# 59912
city: Osaka
country: Japan
facility: Site Reference ID/Investigator# 59914
city: Osaka
country: Japan
facility: Site Reference ID/Investigator# 59915
city: Osaka
country: Japan
facility: Site Reference ID/Investigator# 59934
city: Osaka
country: Japan
facility: Site Reference ID/Investigator# 59940
city: Saga
country: Japan
facility: Site Reference ID/Investigator# 59573
city: Saitama
country: Japan
facility: Site Reference ID/Investigator# 59556
city: Saitama
country: Japan
facility: Site Reference ID/Investigator# 59925
city: Sapporo
country: Japan
facility: Site Reference ID/Investigator# 59555
city: Shiga
country: Japan
facility: Site Reference ID/Investigator# 59810
city: Shimane
country: Japan
facility: Site Reference ID/Investigator# 59852
city: Suwa
country: Japan
facility: Site Reference ID/Investigator# 59855
city: Tochigi
country: Japan
facility: Site Reference ID/Investigator# 59909
city: Tokyo
country: Japan
facility: Site Reference ID/Investigator# 59557
city: Tokyo
country: Japan
facility: Site Reference ID/Investigator# 59813
city: Tokyo
country: Japan
facility: Site Reference ID/Investigator# 59818
city: Tokyo
country: Japan
facility: Site Reference ID/Investigator# 59850
city: Tokyo
country: Japan
facility: Site Reference ID/Investigator# 59859
city: Tokyo
country: Japan
facility: Site Reference ID/Investigator# 59971
city: Tokyo
country: Japan
facility: Site Reference ID/Investigator# 59973
city: Tokyo
country: Japan
facility: Site Reference ID/Investigator# 59978
city: Toyama
country: Japan
facility: Site Reference ID/Investigator# 59816
city: Toyama
country: Japan
facility: Site Reference ID/Investigator# 59970
city: Wakayama
country: Japan
facility: Site Reference ID/Investigator# 59811
city: Yamagata
country: Japan
facility: Site Reference ID/Investigator# 59856
city: Yamagata
country: Japan
facility: Site Reference ID/Investigator# 59926
city: Yamaguchi
country: Japan
facility: Site Reference ID/Investigator# 59817
city: Yamaguchi
country: Japan
facility: Site Reference ID/Investigator# 59924
city: Yamanashi
country: Japan
facility: Site Reference ID/Investigator# 59846
city: Yokohama
country: Japan
facility: Site Reference ID/Investigator# 59828
Study officials:
affiliation: Abbott
name: Toshiaki Yamaguchi, BS Pharm
role: STUDY_DIRECTOR
References: