A Study of SA-001 to Treat Pancreatic Exocrine Insufficiency

July 27, 2011 updated by: Abbott

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

274

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: P
Drug: Placebo
Placebo
Experimental: L
Drug: SA-001
0.25 g of SA-001 pellets/capsule, 12 capsules/day for 7 days
Drug: SA-001
0.25 g of SA-001 pellets/capsule, 6 capsules/day for 7 days
Experimental: H
Drug: SA-001
0.25 g of SA-001 pellets/capsule, 12 capsules/day for 7 days
Drug: SA-001
0.25 g of SA-001 pellets/capsule, 6 capsules/day for 7 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in CFA from baseline to the end of double-blind treatment
Time Frame: 7 days after baseline
7 days after baseline

Secondary Outcome Measures

Outcome Measure
Time Frame
Stool fat excretion, stool weight, stool frequency, nutritional parameters
Time Frame: 7 days after baseline
7 days after baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott

Investigators

  • Study Director: Toshiaki Yamaguchi, BS Pharm, Abbott

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (Actual)

August 1, 2009

Study Completion (Actual)

August 1, 2009

Study Registration Dates

First Submitted

November 16, 2006

First Submitted That Met QC Criteria

November 16, 2006

First Posted (Estimate)

November 17, 2006

Study Record Updates

Last Update Posted (Estimate)

July 28, 2011

Last Update Submitted That Met QC Criteria

July 27, 2011

Last Verified

July 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S245.3.122

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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