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
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:
Exocrine Pancreatic Insufficiency
Pancreatitis
Pancreatitis, Chronic
Pancreatic Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on April 21, 2014