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
  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:


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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00400842

  Hide Study Locations
Locations
Japan
Site Reference ID/Investigator# 59933
Aichi, Japan
Site Reference ID/Investigator# 59845
Aichi, Japan
Site Reference ID/Investigator# 59928
Akita, Japan
Site Reference ID/Investigator# 59983
Amori, Japan
Site Reference ID/Investigator# 59984
Amori, Japan
Site Reference ID/Investigator# 59938
Ehime, Japan
Site Reference ID/Investigator# 59569
Ehime, Japan
Site Reference ID/Investigator# 59923
Fukuoka, Japan
Site Reference ID/Investigator# 59826
Fukuoka, Japan
Site Reference ID/Investigator# 59980
Fukuoka, Japan
Site Reference ID/Investigator# 59571
Fukuoka, Japan
Site Reference ID/Investigator# 59572
Fukuoka, Japan
Site Reference ID/Investigator# 59812
Fukuoka, Japan
Site Reference ID/Investigator# 59922
Fukuoka, Japan
Site Reference ID/Investigator# 59848
Fukuoka, Japan
Site Reference ID/Investigator# 59932
Fukushima, Japan
Site Reference ID/Investigator# 59935
Fukushima, Japan
Site Reference ID/Investigator# 59930
Higashiibaraki, Japan
Site Reference ID/Investigator# 59929
Hiroshima, Japan
Site Reference ID/Investigator# 59968
Hiroshima, Japan
Site Reference ID/Investigator# 59972
Hiroshima, Japan
Site Reference ID/Investigator# 59981
Hokkaido, Japan
Site Reference ID/Investigator# 59982
Hokkaido, Japan
Site Reference ID/Investigator# 59974
Hokkaido, Japan
Site Reference ID/Investigator# 59969
Hokkaido, Japan
Site Reference ID/Investigator# 59939
Hokkaido, Japan
Site Reference ID/Investigator# 59827
Hokkaido, Japan
Site Reference ID/Investigator# 59576
Hyogo, Japan
Site Reference ID/Investigator# 59847
Hyogo, Japan
Site Reference ID/Investigator# 59908
Hyogo, Japan
Site Reference ID/Investigator# 59830
Hyogo, Japan
Site Reference ID/Investigator# 59907
Hyogo, Japan
Site Reference ID/Investigator# 59566
Ishikawa, Japan
Site Reference ID/Investigator# 59911
Ishikawa, Japan
Site Reference ID/Investigator# 59931
Kagoshima, Japan
Site Reference ID/Investigator# 59819
Kanagawa, Japan
Site Reference ID/Investigator# 59844
Kanagawa, Japan
Site Reference ID/Investigator# 59823
Kanagawa, Japan
Site Reference ID/Investigator# 59858
Kanagawa, Japan
Site Reference ID/Investigator# 59564
Kanagawa, Japan
Site Reference ID/Investigator# 59565
Kanagawa, Japan
Site Reference ID/Investigator# 59820
Kanagawa, Japan
Site Reference ID/Investigator# 59570
Kouchi, Japan
Site Reference ID/Investigator# 59574
Kumamoto, Japan
Site Reference ID/Investigator# 59854
Kurihara, Japan
Site Reference ID/Investigator# 59821
Kyoto, Japan
Site Reference ID/Investigator# 59979
Mie, Japan
Site Reference ID/Investigator# 59910
MIE, Japan
Site Reference ID/Investigator# 59976
Miyagi, Japan
Site Reference ID/Investigator# 59977
Miyagi, Japan
Site Reference ID/Investigator# 59849
Miyagi, Japan
Site Reference ID/Investigator# 59975
Miyagi, Japan
Site Reference ID/Investigator# 59857
Miyagi, Japan
Site Reference ID/Investigator# 59851
Miyagi, Japan
Site Reference ID/Investigator# 59937
Miyazaki, Japan
Site Reference ID/Investigator# 59913
Nagano, Japan
Site Reference ID/Investigator# 59825
Nagasaki, Japan
Site Reference ID/Investigator# 59814
Nagoya, Japan
Site Reference ID/Investigator# 59936
Nagoya-city, Japan
Site Reference ID/Investigator# 59927
Nara, Japan
Site Reference ID/Investigator# 59577
Okayama, Japan
Site Reference ID/Investigator# 59824
Osaka, Japan
Site Reference ID/Investigator# 59815
Osaka, Japan
Site Reference ID/Investigator# 59575
Osaka, Japan
Site Reference ID/Investigator# 59912
Osaka, Japan
Site Reference ID/Investigator# 59915
Osaka, Japan
Site Reference ID/Investigator# 59568
Osaka, Japan
Site Reference ID/Investigator# 59567
Osaka, Japan
Site Reference ID/Investigator# 59940
Osaka, Japan
Site Reference ID/Investigator# 59829
Osaka, Japan
Site Reference ID/Investigator# 59914
Osaka, Japan
Site Reference ID/Investigator# 59934
Osaka, Japan
Site Reference ID/Investigator# 59822
Osaka, Japan
Site Reference ID/Investigator# 59573
Saga, Japan
Site Reference ID/Investigator# 59925
Saitama, Japan
Site Reference ID/Investigator# 59556
Saitama, Japan
Site Reference ID/Investigator# 59555
Sapporo, Japan
Site Reference ID/Investigator# 59810
Shiga, Japan
Site Reference ID/Investigator# 59852
Shimane, Japan
Site Reference ID/Investigator# 59855
Suwa, Japan
Site Reference ID/Investigator# 59909
Tochigi, Japan
Site Reference ID/Investigator# 59973
Tokyo, Japan
Site Reference ID/Investigator# 59818
Tokyo, Japan
Site Reference ID/Investigator# 59859
Tokyo, Japan
Site Reference ID/Investigator# 59850
Tokyo, Japan
Site Reference ID/Investigator# 59557
Tokyo, Japan
Site Reference ID/Investigator# 59978
Tokyo, Japan
Site Reference ID/Investigator# 59813
Tokyo, Japan
Site Reference ID/Investigator# 59971
Tokyo, Japan
Site Reference ID/Investigator# 59816
Toyama, Japan
Site Reference ID/Investigator# 59970
Toyama, Japan
Site Reference ID/Investigator# 59811
Wakayama, Japan
Site Reference ID/Investigator# 59856
Yamagata, Japan
Site Reference ID/Investigator# 59926
Yamagata, Japan
Site Reference ID/Investigator# 59924
Yamaguchi, Japan
Site Reference ID/Investigator# 59817
Yamaguchi, Japan
Site Reference ID/Investigator# 59846
Yamanashi, Japan
Site Reference ID/Investigator# 59828
Yokohama, Japan
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:
Pancreatitis
Pancreatitis, Chronic
Exocrine Pancreatic Insufficiency
Pancreatic Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on September 16, 2014