A Open-Label Study to Assess the Safety of Oral Long-Term Use of SA-001 in Pancreatic Exocrine Insufficiency - Full Text View

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

This study is currently recruiting participants.
Verified by Solvay Pharmaceuticals, September 2008

Sponsored by:	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

U.S. FDA Resources

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:	February 2010
Estimated Primary Completion Date:	February 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

Contacts


Contact: Toshiaki Yamaguchi		Toshiaki.Yamaguchi@solvay.com

Show 68 Study Locations

Sponsors and Collaborators

Solvay Pharmaceuticals

Investigators


Study Director:	Global Clinical Director Solvay	Solvay Pharmaceuticals

More Information

Responsible Party:	Solvay Pharmaceuticals ( Toshiaki Yamaguchi )
Study ID Numbers:	S245.3.123
First Received:	November 16, 2006
Last Updated:	September 25, 2008
ClinicalTrials.gov Identifier:	NCT00401076
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Solvay Pharmaceuticals:

SA-001

Pancreatic Exocrine Insufficiency

Chronic Pancreatitis

Pancreatectomy

Study placed in the following topic categories:

Digestive System Diseases

Pancreatic Diseases

Pancreatitis

Pancreatitis, Chronic

ClinicalTrials.gov processed this record on October 10, 2008