Clinical trial NCT00401076: A Open-label Study to Assess the Safety of Oral Long-term Use of SA-001 in Pancreatic Exocrine Insufficiency
Official title: A One-year Open-label Study to Assess the Safety of Oral Long-term Use 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: Pancreatic Exocrine Insufficiency, Chronic Pancreatitis, Pancreatectomy
Keywords: SA-001
Pancreatic Exocrine Insufficiency
Chronic Pancreatitis
Pancreatectomy
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2006-11-17
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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)
timeFrame: 52 weeks
Secondary outcomes:
measure: 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)
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Fukuoka
country: Japan
facility: Site Reference ID/Investigator# 45211
city: Fukuoka
country: Japan
facility: Site Reference ID/Investigator# 45297
city: Hiroshima
country: Japan
facility: Site Reference ID/Investigator# 45220
city: Hiroshima
country: Japan
facility: Site Reference ID/Investigator# 45279
city: Hokkaido
country: Japan
facility: Site Reference ID/Investigator# 45223
city: Hokkaido
country: Japan
facility: Site Reference ID/Investigator# 45303
city: Hyogo
country: Japan
facility: Site Reference ID/Investigator# 45091
city: Kanagawa
country: Japan
facility: Site Reference ID/Investigator# 45110
city: Kanagawa
country: Japan
facility: Site Reference ID/Investigator# 45213
city: Kyoto
country: Japan
facility: Site Reference ID/Investigator# 45207
city: Miyagi
country: Japan
facility: Site Reference ID/Investigator# 45111
city: Miyagi
country: Japan
facility: Site Reference ID/Investigator# 45282
city: Nagasaki
country: Japan
facility: Site Reference ID/Investigator# 45283
city: Osaka
country: Japan
facility: Site Reference ID/Investigator# 45106
city: Sapporo
country: Japan
facility: Site Reference ID/Investigator# 45242
city: Tokyo
country: Japan
facility: Site Reference ID/Investigator# 45281
city: Yamaguchi
country: Japan
facility: Site Reference ID/Investigator# 45299
Study officials:
affiliation: Abbott
name: Toshiaki Yamaguchi, BS Pharm
role: STUDY_DIRECTOR
References: