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A Study of SA-001 to Treat Pancreatic Exocrine Insufficiency

NCT ID: NCT00400842

Last Updated: 2011-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

274 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2009-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Exocrine Pancreatic Insufficiency, Chronic Pancreatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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L

Group Type EXPERIMENTAL

SA-001

Intervention Type DRUG

0.25 g of SA-001 pellets/capsule, 12 capsules/day for 7 days

H

Group Type EXPERIMENTAL

SA-001

Intervention Type DRUG

0.25 g of SA-001 pellets/capsule, 6 capsules/day for 7 days

P

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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SA-001

0.25 g of SA-001 pellets/capsule, 12 capsules/day for 7 days

Intervention Type DRUG

SA-001

0.25 g of SA-001 pellets/capsule, 6 capsules/day for 7 days

Intervention Type DRUG

Placebo

Placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abbott

INDUSTRY

Sponsor Role lead

Responsible Party

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Abbott

Principal Investigators

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Toshiaki Yamaguchi, BS Pharm

Role: STUDY_DIRECTOR

Abbott

Locations

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Site Reference ID/Investigator# 59845

Aichi, , Japan

Site Status

Site Reference ID/Investigator# 59933

Aichi, , Japan

Site Status

Site Reference ID/Investigator# 59928

Akita, , Japan

Site Status

Site Reference ID/Investigator# 59983

Amori, , Japan

Site Status

Site Reference ID/Investigator# 59984

Amori, , Japan

Site Status

Site Reference ID/Investigator# 59569

Ehime, , Japan

Site Status

Site Reference ID/Investigator# 59938

Ehime, , Japan

Site Status

Site Reference ID/Investigator# 59571

Fukuoka, , Japan

Site Status

Site Reference ID/Investigator# 59572

Fukuoka, , Japan

Site Status

Site Reference ID/Investigator# 59812

Fukuoka, , Japan

Site Status

Site Reference ID/Investigator# 59826

Fukuoka, , Japan

Site Status

Site Reference ID/Investigator# 59848

Fukuoka, , Japan

Site Status

Site Reference ID/Investigator# 59922

Fukuoka, , Japan

Site Status

Site Reference ID/Investigator# 59923

Fukuoka, , Japan

Site Status

Site Reference ID/Investigator# 59980

Fukuoka, , Japan

Site Status

Site Reference ID/Investigator# 59932

Fukushima, , Japan

Site Status

Site Reference ID/Investigator# 59935

Fukushima, , Japan

Site Status

Site Reference ID/Investigator# 59930

Higashiibaraki, , Japan

Site Status

Site Reference ID/Investigator# 59929

Hiroshima, , Japan

Site Status

Site Reference ID/Investigator# 59968

Hiroshima, , Japan

Site Status

Site Reference ID/Investigator# 59972

Hiroshima, , Japan

Site Status

Site Reference ID/Investigator# 59827

Hokkaido, , Japan

Site Status

Site Reference ID/Investigator# 59939

Hokkaido, , Japan

Site Status

Site Reference ID/Investigator# 59969

Hokkaido, , Japan

Site Status

Site Reference ID/Investigator# 59974

Hokkaido, , Japan

Site Status

Site Reference ID/Investigator# 59981

Hokkaido, , Japan

Site Status

Site Reference ID/Investigator# 59982

Hokkaido, , Japan

Site Status

Site Reference ID/Investigator# 59576

Hyōgo, , Japan

Site Status

Site Reference ID/Investigator# 59830

Hyōgo, , Japan

Site Status

Site Reference ID/Investigator# 59847

Hyōgo, , Japan

Site Status

Site Reference ID/Investigator# 59907

Hyōgo, , Japan

Site Status

Site Reference ID/Investigator# 59908

Hyōgo, , Japan

Site Status

Site Reference ID/Investigator# 59566

Ishikawa, , Japan

Site Status

Site Reference ID/Investigator# 59911

Ishikawa, , Japan

Site Status

Site Reference ID/Investigator# 59931

Kagoshima, , Japan

Site Status

Site Reference ID/Investigator# 59564

Kanagawa, , Japan

Site Status

Site Reference ID/Investigator# 59565

Kanagawa, , Japan

Site Status

Site Reference ID/Investigator# 59819

Kanagawa, , Japan

Site Status

Site Reference ID/Investigator# 59820

Kanagawa, , Japan

Site Status

Site Reference ID/Investigator# 59823

Kanagawa, , Japan

Site Status

Site Reference ID/Investigator# 59844

Kanagawa, , Japan

Site Status

Site Reference ID/Investigator# 59858

Kanagawa, , Japan

Site Status

Site Reference ID/Investigator# 59570

Kouchi, , Japan

Site Status

Site Reference ID/Investigator# 59574

Kumamoto, , Japan

Site Status

Site Reference ID/Investigator# 59854

Kurihara, , Japan

Site Status

Site Reference ID/Investigator# 59821

Kyoto, , Japan

Site Status

Site Reference ID/Investigator# 59910

Mie, , Japan

Site Status

Site Reference ID/Investigator# 59979

Mie, , Japan

Site Status

Site Reference ID/Investigator# 59849

Miyagi, , Japan

Site Status

Site Reference ID/Investigator# 59851

Miyagi, , Japan

Site Status

Site Reference ID/Investigator# 59857

Miyagi, , Japan

Site Status

Site Reference ID/Investigator# 59975

Miyagi, , Japan

Site Status

Site Reference ID/Investigator# 59976

Miyagi, , Japan

Site Status

Site Reference ID/Investigator# 59977

Miyagi, , Japan

Site Status

Site Reference ID/Investigator# 59937

Miyazaki, , Japan

Site Status

Site Reference ID/Investigator# 59913

Nagano, , Japan

Site Status

Site Reference ID/Investigator# 59825

Nagasaki, , Japan

Site Status

Site Reference ID/Investigator# 59814

Nagoya, , Japan

Site Status

Site Reference ID/Investigator# 59936

Nagoya, , Japan

Site Status

Site Reference ID/Investigator# 59927

Nara, , Japan

Site Status

Site Reference ID/Investigator# 59577

Okayama, , Japan

Site Status

Site Reference ID/Investigator# 59567

Osaka, , Japan

Site Status

Site Reference ID/Investigator# 59568

Osaka, , Japan

Site Status

Site Reference ID/Investigator# 59575

Osaka, , Japan

Site Status

Site Reference ID/Investigator# 59815

Osaka, , Japan

Site Status

Site Reference ID/Investigator# 59822

Osaka, , Japan

Site Status

Site Reference ID/Investigator# 59824

Osaka, , Japan

Site Status

Site Reference ID/Investigator# 59829

Osaka, , Japan

Site Status

Site Reference ID/Investigator# 59912

Osaka, , Japan

Site Status

Site Reference ID/Investigator# 59914

Osaka, , Japan

Site Status

Site Reference ID/Investigator# 59915

Osaka, , Japan

Site Status

Site Reference ID/Investigator# 59934

Osaka, , Japan

Site Status

Site Reference ID/Investigator# 59940

Osaka, , Japan

Site Status

Site Reference ID/Investigator# 59573

Saga, , Japan

Site Status

Site Reference ID/Investigator# 59556

Saitama, , Japan

Site Status

Site Reference ID/Investigator# 59925

Saitama, , Japan

Site Status

Site Reference ID/Investigator# 59555

Sapporo, , Japan

Site Status

Site Reference ID/Investigator# 59810

Shiga, , Japan

Site Status

Site Reference ID/Investigator# 59852

Shimane, , Japan

Site Status

Site Reference ID/Investigator# 59855

Suwa, , Japan

Site Status

Site Reference ID/Investigator# 59909

Tochigi, , Japan

Site Status

Site Reference ID/Investigator# 59557

Tokyo, , Japan

Site Status

Site Reference ID/Investigator# 59813

Tokyo, , Japan

Site Status

Site Reference ID/Investigator# 59818

Tokyo, , Japan

Site Status

Site Reference ID/Investigator# 59850

Tokyo, , Japan

Site Status

Site Reference ID/Investigator# 59859

Tokyo, , Japan

Site Status

Site Reference ID/Investigator# 59971

Tokyo, , Japan

Site Status

Site Reference ID/Investigator# 59973

Tokyo, , Japan

Site Status

Site Reference ID/Investigator# 59978

Tokyo, , Japan

Site Status

Site Reference ID/Investigator# 59816

Toyama, , Japan

Site Status

Site Reference ID/Investigator# 59970

Toyama, , Japan

Site Status

Site Reference ID/Investigator# 59811

Wakayama, , Japan

Site Status

Site Reference ID/Investigator# 59856

Yamagata, , Japan

Site Status

Site Reference ID/Investigator# 59926

Yamagata, , Japan

Site Status

Site Reference ID/Investigator# 59817

Yamaguchi, , Japan

Site Status

Site Reference ID/Investigator# 59924

Yamaguchi, , Japan

Site Status

Site Reference ID/Investigator# 59846

Yamanashi, , Japan

Site Status

Site Reference ID/Investigator# 59828

Yokohama, , Japan

Site Status

Countries

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Japan

Other Identifiers

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S245.3.122

Identifier Type: -

Identifier Source: org_study_id

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