A Study of SA-001 to Treat Pancreatic Exocrine Insufficiency - Full Text View

Sponsored by:	Solvay Pharmaceuticals
Information provided by:	Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00400842

Purpose

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.

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

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Solvay Pharmaceuticals:

Primary Outcome Measures:

Change in CFA from baseline to the end of double-blind treatment [ Time Frame: 7 days after baseline ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Stool fat excretion, stool weight, stool frequency, nutritional parameters [ Time Frame: 7 days after baseline ] [ Designated as safety issue: No ]

Estimated Enrollment:	75
Study Start Date:	May 2007
Estimated Study Completion Date:	February 2009
Estimated Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
L: Experimental	Drug: SA-001 0.25 g of SA-001 pellets/capsule, 12 capsules/day for 7 days
H: Experimental	Drug: SA-001 0.25 g of SA-001 pellets/capsule, 6 capsules/day for 7 days
P: Placebo Comparator	Drug: Placebo Placebo

Eligibility

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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00400842

Contacts

Contact: Toshiaki Yamaguchi

Toshiaki.Yamaguchi@solvay.com

Show 73 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:	S245.3.122
Study First Received:	November 16, 2006
Last Updated:	November 20, 2008
ClinicalTrials.gov Identifier:	NCT00400842
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Solvay Pharmaceuticals:

SA-001
Pancreatic Exocrine Insufficiency
Pancreatectomy

Study placed in the following topic categories:

Digestive System Diseases
Pancreatic Diseases
Exocrine Pancreatic Insufficiency
Pancreatitis
Pancreatitis, Chronic

ClinicalTrials.gov processed this record on January 16, 2009