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: October 27, 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

Show 49 Study Locations

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:	October 27, 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 09, 2009