A Study of SA-001 to Treat Pancreatic Exocrine Insufficiency

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00400842
First received: November 16, 2006
Last updated: July 27, 2011
Last verified: July 2011

November 16, 2006
July 27, 2011
May 2007
August 2009   (final data collection date for primary outcome measure)
Change in CFA from baseline to the end of double-blind treatment [ Time Frame: 7 days after baseline ] [ Designated as safety issue: No ]
Change in Coefficient of Fat Absorption
Complete list of historical versions of study NCT00400842 on ClinicalTrials.gov Archive Site
Stool fat excretion, stool weight, stool frequency, nutritional parameters [ Time Frame: 7 days after baseline ] [ Designated as safety issue: No ]
Stool fat excretion, Stool weight, Stool frequency
Not Provided
Not Provided
 
A Study of SA-001 to Treat Pancreatic Exocrine Insufficiency
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Exocrine Pancreatic Insufficiency, Chronic Pancreatitis
  • Drug: SA-001
    0.25 g of SA-001 pellets/capsule, 12 capsules/day for 7 days
  • Drug: SA-001
    0.25 g of SA-001 pellets/capsule, 6 capsules/day for 7 days
  • Drug: Placebo
    Placebo
  • Experimental: L
    Intervention: Drug: SA-001
  • Experimental: H
    Intervention: Drug: SA-001
  • Placebo Comparator: P
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
274
August 2009
August 2009   (final data collection date for primary outcome measure)

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
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00400842
S245.3.122
No
Toshiaki Yamaguchi, Sr. Clinical Program Manager, Abbott
Abbott
Not Provided
Study Director: Toshiaki Yamaguchi, BS Pharm Abbott
Abbott
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP