A Open-label Study to Assess the Safety of Oral Long-term Use of SA-001 in Pancreatic Exocrine Insufficiency

This study is ongoing, but not recruiting participants.

First Received: November 16, 2006 Last Updated: November 24, 2009 History of Changes

Sponsor:	Solvay Pharmaceuticals
Information provided by:	Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00401076

Purpose

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.

Condition	Intervention	Phase
Pancreatic Exocrine Insufficiency Chronic Pancreatitis Pancreatectomy	Drug: SA-001	Phase III

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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

Further study details as provided by Solvay Pharmaceuticals:

Primary Outcome Measures:

Adverse events, vital signs, safety laboratory parameters [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Nutritional parameters [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	75
Study Start Date:	September 2007
Estimated Study Completion Date:	November 2010
Estimated Primary Completion Date:	November 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: SA-001 0.25 g of SA-001 pellets/capsule, 12 capsules/day for 7 days

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subjects who complete the S2453122 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 subinvestigator, because they experienced adverse drug reactions in the S2453122 clinical study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00401076

Hide Study Locations

Locations

Japan
Site 4
Fukuoka, Japan
Site 8
Kanagawa, Japan
Site 9
Hokkaido, Japan
Site 11
Hiroshima, Japan
Site 14
Okayama, Japan
Site 18
Tokyo, Japan
Site 24
Hiroshima, Japan
Site 25
Hokkaido, Japan
Site 28
Kanagawa, Japan
Site 29
Osaka, Japan
Site 31
Hokkaido, Japan
Site 33
Miyagi, Japan
Site 36
Kanagawa, Japan
Site 39
Aichi, Japan
Site 42
Fukuoka, Japan
Site 43
Fukuoka, Japan
Site 44
Nagasaki, Japan
Site 46
Tokyo, Japan
Site 48
Kyoto, Japan
Site 52
Miyagi, Japan
Site 53
Miyagi, Japan
Site 54
Tokyo, Japan
Site 55
Yamaguchi, Japan
Site 58
Yamanashi, Japan
Site 97
Osaka, Japan
Site 61
Yamagata, Japan
Site 64
Fukuoka, Japan
Site 65
Fukuoka, Japan
Site 67
Hyogo, Japan
Site 70
Osaka, Japan
Site 71
Osaka, Japan
Site 73
Tochigi, Japan
Site 74
Mie, Japan
Site 75
Osaka, Japan
Site 76
Osaka, Japan
Site 78
Hyogo, Japan
Site 79
Hyogo, Japan
Site 80
Fukuoka, Japan
Site 82
Fukuoka, Japan
Site 83
Akita, Japan
Site 85
Ibaragi, Japan
Site 86
Saitama, Japan
Site 87
Nara, Japan
Site 92
Ehime, Japan
Site 93
Miyazaki, Japan
Site 94
Fukushima, Japan
Site 95
Fukushima, Japan
Site 96
Osaka, Japan
Site 59
Nagano, Japan

Sponsors and Collaborators

Solvay Pharmaceuticals

Investigators

Study Director:

Global Clinical Director Solvay

Solvay Pharmaceuticals

More Information

No publications provided

Responsible Party:	Solvay Pharmaceuticals ( Toshiaki Yamaguchi )
Study ID Numbers:	S245.3.123
Study First Received:	November 16, 2006
Last Updated:	November 24, 2009
ClinicalTrials.gov Identifier:	NCT00401076 History of Changes
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Solvay Pharmaceuticals:

SA-001
Pancreatic Exocrine Insufficiency
Chronic Pancreatitis
Pancreatectomy

Additional relevant MeSH terms:

Digestive System Diseases
Pancreatic Diseases
Pancreatitis
Pancreatitis, Chronic

ClinicalTrials.gov processed this record on November 27, 2009