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A Open-label Study to Assess the Safety of Oral Long-term Use of SA-001 in Pancreatic Exocrine Insufficiency

NCT ID: NCT00401076

Last Updated: 2011-08-01

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

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2010-09-30

Brief Summary

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This study is to evaluate the safety of 3.0 g/day of SA-001 (to be flexibly increased or decreased with the range from 1.5 g/day to 6.0 g/day), which will orally be administered for 52 weeks to patients with pancreatic exocrine insufficiency caused by chronic pancreatitis in the non-compensatory stage or by pancreatectomy.

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Detailed Description

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Conditions

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Pancreatic Exocrine Insufficiency, Chronic Pancreatitis, Pancreatectomy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

SA-001

Intervention Type DRUG

0.25 g of SA-001 pellets/capsule, 12 capsules/day for 52 weeks

Interventions

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SA-001

0.25 g of SA-001 pellets/capsule, 12 capsules/day for 52 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Inclusion Criteria Subjects who complete the S245.3.122 clinical study (excluding discontinued subjects).

Exclusion Criteria Subjects who are assessed to be inappropriate for continuing long-term use of SA-001, at the discretion of the investigator or the sub-investigator, because they experienced adverse drug reactions in the S245.3.122 clinical study.
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# 45211

Fukuoka, , Japan

Site Status

Site Reference ID/Investigator# 45297

Fukuoka, , Japan

Site Status

Site Reference ID/Investigator# 45220

Hiroshima, , Japan

Site Status

Site Reference ID/Investigator# 45279

Hiroshima, , Japan

Site Status

Site Reference ID/Investigator# 45223

Hokkaido, , Japan

Site Status

Site Reference ID/Investigator# 45303

Hokkaido, , Japan

Site Status

Site Reference ID/Investigator# 45091

Hyōgo, , Japan

Site Status

Site Reference ID/Investigator# 45110

Kanagawa, , Japan

Site Status

Site Reference ID/Investigator# 45213

Kanagawa, , Japan

Site Status

Site Reference ID/Investigator# 45207

Kyoto, , Japan

Site Status

Site Reference ID/Investigator# 45111

Miyagi, , Japan

Site Status

Site Reference ID/Investigator# 45282

Miyagi, , Japan

Site Status

Site Reference ID/Investigator# 45283

Nagasaki, , Japan

Site Status

Site Reference ID/Investigator# 45106

Osaka, , Japan

Site Status

Site Reference ID/Investigator# 45242

Sapporo, , Japan

Site Status

Site Reference ID/Investigator# 45281

Tokyo, , Japan

Site Status

Site Reference ID/Investigator# 45299

Yamaguchi, , Japan

Site Status

Countries

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Japan

Other Identifiers

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S245.3.123

Identifier Type: -

Identifier Source: org_study_id

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