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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
History of Changes
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Pancreatitis
U.S. FDA Resources

Further study details as provided by Abbott:

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 ]

Enrollment: 274
Study Start Date: May 2007
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: L Drug: SA-001
0.25 g of SA-001 pellets/capsule, 12 capsules/day for 7 days
Experimental: H Drug: SA-001
0.25 g of SA-001 pellets/capsule, 6 capsules/day for 7 days
Placebo Comparator: P 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

  Show 98 Study Locations
Sponsors and Collaborators
Abbott
Investigators
Study Director: Toshiaki Yamaguchi, BS Pharm Abbott
  More Information

No publications provided

Responsible Party: Toshiaki Yamaguchi, Sr. Clinical Program Manager, Abbott
ClinicalTrials.gov Identifier: NCT00400842     History of Changes
Other Study ID Numbers: S245.3.122
Study First Received: November 16, 2006
Last Updated: July 27, 2011
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Abbott:
SA-001
Pancreatic Exocrine Insufficiency
Pancreatectomy

Additional relevant MeSH terms:
Exocrine Pancreatic Insufficiency
Pancreatitis
Pancreatitis, Chronic
Pancreatic Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 16, 2013