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A Study of SA-001 to Treat Pancreatic Exocrine Insufficiency

Primary Purpose

Exocrine Pancreatic Insufficiency, Chronic Pancreatitis

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
SA-001
SA-001
Placebo
Sponsored by
Abbott
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Exocrine Pancreatic Insufficiency, Chronic Pancreatitis focused on measuring SA-001, Pancreatic Exocrine Insufficiency, Pancreatectomy

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Site Reference ID/Investigator# 59845
  • Site Reference ID/Investigator# 59933
  • Site Reference ID/Investigator# 59928
  • Site Reference ID/Investigator# 59983
  • Site Reference ID/Investigator# 59984
  • Site Reference ID/Investigator# 59569
  • Site Reference ID/Investigator# 59938
  • Site Reference ID/Investigator# 59571
  • Site Reference ID/Investigator# 59572
  • Site Reference ID/Investigator# 59812
  • Site Reference ID/Investigator# 59826
  • Site Reference ID/Investigator# 59848
  • Site Reference ID/Investigator# 59922
  • Site Reference ID/Investigator# 59923
  • Site Reference ID/Investigator# 59980
  • Site Reference ID/Investigator# 59932
  • Site Reference ID/Investigator# 59935
  • Site Reference ID/Investigator# 59930
  • Site Reference ID/Investigator# 59929
  • Site Reference ID/Investigator# 59968
  • Site Reference ID/Investigator# 59972
  • Site Reference ID/Investigator# 59827
  • Site Reference ID/Investigator# 59939
  • Site Reference ID/Investigator# 59969
  • Site Reference ID/Investigator# 59974
  • Site Reference ID/Investigator# 59981
  • Site Reference ID/Investigator# 59982
  • Site Reference ID/Investigator# 59576
  • Site Reference ID/Investigator# 59830
  • Site Reference ID/Investigator# 59847
  • Site Reference ID/Investigator# 59907
  • Site Reference ID/Investigator# 59908
  • Site Reference ID/Investigator# 59566
  • Site Reference ID/Investigator# 59911
  • Site Reference ID/Investigator# 59931
  • Site Reference ID/Investigator# 59564
  • Site Reference ID/Investigator# 59565
  • Site Reference ID/Investigator# 59819
  • Site Reference ID/Investigator# 59820
  • Site Reference ID/Investigator# 59823
  • Site Reference ID/Investigator# 59844
  • Site Reference ID/Investigator# 59858
  • Site Reference ID/Investigator# 59570
  • Site Reference ID/Investigator# 59574
  • Site Reference ID/Investigator# 59854
  • Site Reference ID/Investigator# 59821
  • Site Reference ID/Investigator# 59910
  • Site Reference ID/Investigator# 59979
  • Site Reference ID/Investigator# 59849
  • Site Reference ID/Investigator# 59851
  • Site Reference ID/Investigator# 59857
  • Site Reference ID/Investigator# 59975
  • Site Reference ID/Investigator# 59976
  • Site Reference ID/Investigator# 59977
  • Site Reference ID/Investigator# 59937
  • Site Reference ID/Investigator# 59913
  • Site Reference ID/Investigator# 59825
  • Site Reference ID/Investigator# 59936
  • Site Reference ID/Investigator# 59814
  • Site Reference ID/Investigator# 59927
  • Site Reference ID/Investigator# 59577
  • Site Reference ID/Investigator# 59567
  • Site Reference ID/Investigator# 59568
  • Site Reference ID/Investigator# 59575
  • Site Reference ID/Investigator# 59815
  • Site Reference ID/Investigator# 59822
  • Site Reference ID/Investigator# 59824
  • Site Reference ID/Investigator# 59829
  • Site Reference ID/Investigator# 59912
  • Site Reference ID/Investigator# 59914
  • Site Reference ID/Investigator# 59915
  • Site Reference ID/Investigator# 59934
  • Site Reference ID/Investigator# 59940
  • Site Reference ID/Investigator# 59573
  • Site Reference ID/Investigator# 59556
  • Site Reference ID/Investigator# 59925
  • Site Reference ID/Investigator# 59555
  • Site Reference ID/Investigator# 59810
  • Site Reference ID/Investigator# 59852
  • Site Reference ID/Investigator# 59855
  • Site Reference ID/Investigator# 59909
  • Site Reference ID/Investigator# 59557
  • Site Reference ID/Investigator# 59813
  • Site Reference ID/Investigator# 59818
  • Site Reference ID/Investigator# 59850
  • Site Reference ID/Investigator# 59859
  • Site Reference ID/Investigator# 59971
  • Site Reference ID/Investigator# 59973
  • Site Reference ID/Investigator# 59978
  • Site Reference ID/Investigator# 59816
  • Site Reference ID/Investigator# 59970
  • Site Reference ID/Investigator# 59811
  • Site Reference ID/Investigator# 59856
  • Site Reference ID/Investigator# 59926
  • Site Reference ID/Investigator# 59817
  • Site Reference ID/Investigator# 59924
  • Site Reference ID/Investigator# 59846
  • Site Reference ID/Investigator# 59828

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

L

H

P

Arm Description

Outcomes

Primary Outcome Measures

Change in CFA from baseline to the end of double-blind treatment

Secondary Outcome Measures

Stool fat excretion, stool weight, stool frequency, nutritional parameters

Full Information

First Posted
November 16, 2006
Last Updated
July 27, 2011
Sponsor
Abbott
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1. Study Identification

Unique Protocol Identification Number
NCT00400842
Brief Title
A Study of SA-001 to Treat Pancreatic Exocrine Insufficiency
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 Type
Interventional

2. Study Status

Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
August 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Abbott

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Exocrine Pancreatic Insufficiency, Chronic Pancreatitis
Keywords
SA-001, Pancreatic Exocrine Insufficiency, Pancreatectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
274 (Actual)

8. Arms, Groups, and Interventions

Arm Title
L
Arm Type
Experimental
Arm Title
H
Arm Type
Experimental
Arm Title
P
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
SA-001
Intervention Description
0.25 g of SA-001 pellets/capsule, 12 capsules/day for 7 days
Intervention Type
Drug
Intervention Name(s)
SA-001
Intervention Description
0.25 g of SA-001 pellets/capsule, 6 capsules/day for 7 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Change in CFA from baseline to the end of double-blind treatment
Time Frame
7 days after baseline
Secondary Outcome Measure Information:
Title
Stool fat excretion, stool weight, stool frequency, nutritional parameters
Time Frame
7 days after baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Toshiaki Yamaguchi, BS Pharm
Organizational Affiliation
Abbott
Official's Role
Study Director
Facility Information:
Facility Name
Site Reference ID/Investigator# 59845
City
Aichi
Country
Japan
Facility Name
Site Reference ID/Investigator# 59933
City
Aichi
Country
Japan
Facility Name
Site Reference ID/Investigator# 59928
City
Akita
Country
Japan
Facility Name
Site Reference ID/Investigator# 59983
City
Amori
Country
Japan
Facility Name
Site Reference ID/Investigator# 59984
City
Amori
Country
Japan
Facility Name
Site Reference ID/Investigator# 59569
City
Ehime
Country
Japan
Facility Name
Site Reference ID/Investigator# 59938
City
Ehime
Country
Japan
Facility Name
Site Reference ID/Investigator# 59571
City
Fukuoka
Country
Japan
Facility Name
Site Reference ID/Investigator# 59572
City
Fukuoka
Country
Japan
Facility Name
Site Reference ID/Investigator# 59812
City
Fukuoka
Country
Japan
Facility Name
Site Reference ID/Investigator# 59826
City
Fukuoka
Country
Japan
Facility Name
Site Reference ID/Investigator# 59848
City
Fukuoka
Country
Japan
Facility Name
Site Reference ID/Investigator# 59922
City
Fukuoka
Country
Japan
Facility Name
Site Reference ID/Investigator# 59923
City
Fukuoka
Country
Japan
Facility Name
Site Reference ID/Investigator# 59980
City
Fukuoka
Country
Japan
Facility Name
Site Reference ID/Investigator# 59932
City
Fukushima
Country
Japan
Facility Name
Site Reference ID/Investigator# 59935
City
Fukushima
Country
Japan
Facility Name
Site Reference ID/Investigator# 59930
City
Higashiibaraki
Country
Japan
Facility Name
Site Reference ID/Investigator# 59929
City
Hiroshima
Country
Japan
Facility Name
Site Reference ID/Investigator# 59968
City
Hiroshima
Country
Japan
Facility Name
Site Reference ID/Investigator# 59972
City
Hiroshima
Country
Japan
Facility Name
Site Reference ID/Investigator# 59827
City
Hokkaido
Country
Japan
Facility Name
Site Reference ID/Investigator# 59939
City
Hokkaido
Country
Japan
Facility Name
Site Reference ID/Investigator# 59969
City
Hokkaido
Country
Japan
Facility Name
Site Reference ID/Investigator# 59974
City
Hokkaido
Country
Japan
Facility Name
Site Reference ID/Investigator# 59981
City
Hokkaido
Country
Japan
Facility Name
Site Reference ID/Investigator# 59982
City
Hokkaido
Country
Japan
Facility Name
Site Reference ID/Investigator# 59576
City
Hyogo
Country
Japan
Facility Name
Site Reference ID/Investigator# 59830
City
Hyogo
Country
Japan
Facility Name
Site Reference ID/Investigator# 59847
City
Hyogo
Country
Japan
Facility Name
Site Reference ID/Investigator# 59907
City
Hyogo
Country
Japan
Facility Name
Site Reference ID/Investigator# 59908
City
Hyogo
Country
Japan
Facility Name
Site Reference ID/Investigator# 59566
City
Ishikawa
Country
Japan
Facility Name
Site Reference ID/Investigator# 59911
City
Ishikawa
Country
Japan
Facility Name
Site Reference ID/Investigator# 59931
City
Kagoshima
Country
Japan
Facility Name
Site Reference ID/Investigator# 59564
City
Kanagawa
Country
Japan
Facility Name
Site Reference ID/Investigator# 59565
City
Kanagawa
Country
Japan
Facility Name
Site Reference ID/Investigator# 59819
City
Kanagawa
Country
Japan
Facility Name
Site Reference ID/Investigator# 59820
City
Kanagawa
Country
Japan
Facility Name
Site Reference ID/Investigator# 59823
City
Kanagawa
Country
Japan
Facility Name
Site Reference ID/Investigator# 59844
City
Kanagawa
Country
Japan
Facility Name
Site Reference ID/Investigator# 59858
City
Kanagawa
Country
Japan
Facility Name
Site Reference ID/Investigator# 59570
City
Kouchi
Country
Japan
Facility Name
Site Reference ID/Investigator# 59574
City
Kumamoto
Country
Japan
Facility Name
Site Reference ID/Investigator# 59854
City
Kurihara
Country
Japan
Facility Name
Site Reference ID/Investigator# 59821
City
Kyoto
Country
Japan
Facility Name
Site Reference ID/Investigator# 59910
City
MIE
Country
Japan
Facility Name
Site Reference ID/Investigator# 59979
City
Mie
Country
Japan
Facility Name
Site Reference ID/Investigator# 59849
City
Miyagi
Country
Japan
Facility Name
Site Reference ID/Investigator# 59851
City
Miyagi
Country
Japan
Facility Name
Site Reference ID/Investigator# 59857
City
Miyagi
Country
Japan
Facility Name
Site Reference ID/Investigator# 59975
City
Miyagi
Country
Japan
Facility Name
Site Reference ID/Investigator# 59976
City
Miyagi
Country
Japan
Facility Name
Site Reference ID/Investigator# 59977
City
Miyagi
Country
Japan
Facility Name
Site Reference ID/Investigator# 59937
City
Miyazaki
Country
Japan
Facility Name
Site Reference ID/Investigator# 59913
City
Nagano
Country
Japan
Facility Name
Site Reference ID/Investigator# 59825
City
Nagasaki
Country
Japan
Facility Name
Site Reference ID/Investigator# 59936
City
Nagoya-city
Country
Japan
Facility Name
Site Reference ID/Investigator# 59814
City
Nagoya
Country
Japan
Facility Name
Site Reference ID/Investigator# 59927
City
Nara
Country
Japan
Facility Name
Site Reference ID/Investigator# 59577
City
Okayama
Country
Japan
Facility Name
Site Reference ID/Investigator# 59567
City
Osaka
Country
Japan
Facility Name
Site Reference ID/Investigator# 59568
City
Osaka
Country
Japan
Facility Name
Site Reference ID/Investigator# 59575
City
Osaka
Country
Japan
Facility Name
Site Reference ID/Investigator# 59815
City
Osaka
Country
Japan
Facility Name
Site Reference ID/Investigator# 59822
City
Osaka
Country
Japan
Facility Name
Site Reference ID/Investigator# 59824
City
Osaka
Country
Japan
Facility Name
Site Reference ID/Investigator# 59829
City
Osaka
Country
Japan
Facility Name
Site Reference ID/Investigator# 59912
City
Osaka
Country
Japan
Facility Name
Site Reference ID/Investigator# 59914
City
Osaka
Country
Japan
Facility Name
Site Reference ID/Investigator# 59915
City
Osaka
Country
Japan
Facility Name
Site Reference ID/Investigator# 59934
City
Osaka
Country
Japan
Facility Name
Site Reference ID/Investigator# 59940
City
Osaka
Country
Japan
Facility Name
Site Reference ID/Investigator# 59573
City
Saga
Country
Japan
Facility Name
Site Reference ID/Investigator# 59556
City
Saitama
Country
Japan
Facility Name
Site Reference ID/Investigator# 59925
City
Saitama
Country
Japan
Facility Name
Site Reference ID/Investigator# 59555
City
Sapporo
Country
Japan
Facility Name
Site Reference ID/Investigator# 59810
City
Shiga
Country
Japan
Facility Name
Site Reference ID/Investigator# 59852
City
Shimane
Country
Japan
Facility Name
Site Reference ID/Investigator# 59855
City
Suwa
Country
Japan
Facility Name
Site Reference ID/Investigator# 59909
City
Tochigi
Country
Japan
Facility Name
Site Reference ID/Investigator# 59557
City
Tokyo
Country
Japan
Facility Name
Site Reference ID/Investigator# 59813
City
Tokyo
Country
Japan
Facility Name
Site Reference ID/Investigator# 59818
City
Tokyo
Country
Japan
Facility Name
Site Reference ID/Investigator# 59850
City
Tokyo
Country
Japan
Facility Name
Site Reference ID/Investigator# 59859
City
Tokyo
Country
Japan
Facility Name
Site Reference ID/Investigator# 59971
City
Tokyo
Country
Japan
Facility Name
Site Reference ID/Investigator# 59973
City
Tokyo
Country
Japan
Facility Name
Site Reference ID/Investigator# 59978
City
Tokyo
Country
Japan
Facility Name
Site Reference ID/Investigator# 59816
City
Toyama
Country
Japan
Facility Name
Site Reference ID/Investigator# 59970
City
Toyama
Country
Japan
Facility Name
Site Reference ID/Investigator# 59811
City
Wakayama
Country
Japan
Facility Name
Site Reference ID/Investigator# 59856
City
Yamagata
Country
Japan
Facility Name
Site Reference ID/Investigator# 59926
City
Yamagata
Country
Japan
Facility Name
Site Reference ID/Investigator# 59817
City
Yamaguchi
Country
Japan
Facility Name
Site Reference ID/Investigator# 59924
City
Yamaguchi
Country
Japan
Facility Name
Site Reference ID/Investigator# 59846
City
Yamanashi
Country
Japan
Facility Name
Site Reference ID/Investigator# 59828
City
Yokohama
Country
Japan

12. IPD Sharing Statement

Learn more about this trial

A Study of SA-001 to Treat Pancreatic Exocrine Insufficiency

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