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A Study of SA-001 to Treat Pancreatic Exocrine Insufficiency

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ClinicalTrials.gov Identifier: NCT00400842
Recruitment Status : Completed
First Posted : November 17, 2006
Last Update Posted : July 28, 2011
Sponsor:
Information provided by:
Abbott

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

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
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

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
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

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

Responsible Party: Toshiaki Yamaguchi, Sr. Clinical Program Manager, Abbott
ClinicalTrials.gov Identifier: NCT00400842     History of Changes
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:
SA-001
Pancreatic Exocrine Insufficiency
Pancreatectomy

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