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A Study of SA-001 to Treat Pancreatic Exocrine Insufficiency

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00400842
Recruitment Status : Completed
First Posted : November 17, 2006
Last Update Posted : July 28, 2011
Information provided by:

Brief Summary:
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 or disease Intervention/treatment Phase
Exocrine Pancreatic Insufficiency, Chronic Pancreatitis Drug: SA-001 Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 274 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : May 2007
Actual Primary Completion Date : August 2009
Actual Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pancreatitis

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Change in CFA from baseline to the end of double-blind treatment [ Time Frame: 7 days after baseline ]

Secondary Outcome Measures :
  1. Stool fat excretion, stool weight, stool frequency, nutritional parameters [ Time Frame: 7 days after baseline ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00400842

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Sponsors and Collaborators
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Study Director: Toshiaki Yamaguchi, BS Pharm Abbott

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Responsible Party: Toshiaki Yamaguchi, Sr. Clinical Program Manager, Abbott Identifier: NCT00400842    
Other Study ID Numbers: S245.3.122
First Posted: November 17, 2006    Key Record Dates
Last Update Posted: July 28, 2011
Last Verified: July 2011
Keywords provided by Abbott:
Pancreatic Exocrine Insufficiency
Additional relevant MeSH terms:
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Pancreatitis, Chronic
Exocrine Pancreatic Insufficiency
Pancreatic Diseases
Digestive System Diseases