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A Study of SA-001 to Treat Pancreatic Exocrine Insufficiency

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00400842
First Posted: November 17, 2006
Last Update Posted: July 28, 2011
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.
Information provided by:
Abbott
  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
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

Resource links provided by NLM:


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 ]

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier (NCT number): NCT00400842


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

Responsible Party: Toshiaki Yamaguchi, Sr. Clinical Program Manager, Abbott
ClinicalTrials.gov Identifier: NCT00400842     History of Changes
Other Study ID Numbers: S245.3.122
First Submitted: November 16, 2006
First Posted: November 17, 2006
Last Update Posted: July 28, 2011
Last Verified: July 2011

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

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