A Study of SA-001 to Treat Pancreatic Exocrine Insufficiency

NCT00400842 | Completed Phase 3

• 1 other identifier: S245.3.122
• Study Type: interventional
• Target: 274
• Locations: 1 country
• Sites: 98

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.

Conditions

Exocrine Pancreatic Insufficiency, Chronic Pancreatitis

Keywords

SA-001; Pancreatic Exocrine Insufficiency; Pancreatectomy

Outcome Measures

Primary Outcomes (1)

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

  7 days after baseline

Secondary Outcomes (1)

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

  7 days after baseline

Study Arms (3)

L

EXPERIMENTAL

Drug: SA-001

H

EXPERIMENTAL

Drug: SA-001

P

PLACEBO COMPARATOR

Drug: Placebo

Interventions

SA-001 DRUG

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

L

Placebo DRUG

Placebo

P

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abbott: lead

Study Sites (98)

Site Reference ID/Investigator# 59845

Aichi, Japan

Location

Site Reference ID/Investigator# 59933

Aichi, Japan

Location

Site Reference ID/Investigator# 59928

Akita, Japan

Location

Site Reference ID/Investigator# 59983

Amori, Japan

Location

Site Reference ID/Investigator# 59984

Amori, Japan

Location

Site Reference ID/Investigator# 59569

Ehime, Japan

Location

Site Reference ID/Investigator# 59938

Ehime, Japan

Location

Site Reference ID/Investigator# 59571

Fukuoka, Japan

Location

Site Reference ID/Investigator# 59572

Fukuoka, Japan

Location

Site Reference ID/Investigator# 59812

Fukuoka, Japan

Location

Site Reference ID/Investigator# 59826

Fukuoka, Japan

Location

Site Reference ID/Investigator# 59848

Fukuoka, Japan

Location

Site Reference ID/Investigator# 59922

Fukuoka, Japan

Location

Site Reference ID/Investigator# 59923

Fukuoka, Japan

Location

Site Reference ID/Investigator# 59980

Fukuoka, Japan

Location

Site Reference ID/Investigator# 59932

Fukushima, Japan

Location

Site Reference ID/Investigator# 59935

Fukushima, Japan

Location

Site Reference ID/Investigator# 59930

Higashiibaraki, Japan

Location

Site Reference ID/Investigator# 59929

Hiroshima, Japan

Location

Site Reference ID/Investigator# 59968

Hiroshima, Japan

Location

Site Reference ID/Investigator# 59972

Hiroshima, Japan

Location

Site Reference ID/Investigator# 59827

Hokkaido, Japan

Location

Site Reference ID/Investigator# 59939

Hokkaido, Japan

Location

Site Reference ID/Investigator# 59969

Hokkaido, Japan

Location

Site Reference ID/Investigator# 59974

Hokkaido, Japan

Location

Site Reference ID/Investigator# 59981

Hokkaido, Japan

Location

Site Reference ID/Investigator# 59982

Hokkaido, Japan

Location

Site Reference ID/Investigator# 59576

Hyōgo, Japan

Location

Site Reference ID/Investigator# 59830

Hyōgo, Japan

Location

Site Reference ID/Investigator# 59847

Hyōgo, Japan

Location

Site Reference ID/Investigator# 59907

Hyōgo, Japan

Location

Site Reference ID/Investigator# 59908

Hyōgo, Japan

Location

Site Reference ID/Investigator# 59566

Ishikawa, Japan

Location

Site Reference ID/Investigator# 59911

Ishikawa, Japan

Location

Site Reference ID/Investigator# 59931

Kagoshima, Japan

Location

Site Reference ID/Investigator# 59564

Kanagawa, Japan

Location

Site Reference ID/Investigator# 59565

Kanagawa, Japan

Location

Site Reference ID/Investigator# 59819

Kanagawa, Japan

Location

Site Reference ID/Investigator# 59820

Kanagawa, Japan

Location

Site Reference ID/Investigator# 59823

Kanagawa, Japan

Location

Site Reference ID/Investigator# 59844

Kanagawa, Japan

Location

Site Reference ID/Investigator# 59858

Kanagawa, Japan

Location

Site Reference ID/Investigator# 59570

Kouchi, Japan

Location

Site Reference ID/Investigator# 59574

Kumamoto, Japan

Location

Site Reference ID/Investigator# 59854

Kurihara, Japan

Location

Site Reference ID/Investigator# 59821

Kyoto, Japan

Location

Site Reference ID/Investigator# 59910

Mie, Japan

Location

Site Reference ID/Investigator# 59979

Mie, Japan

Location

Site Reference ID/Investigator# 59849

Miyagi, Japan

Location

Site Reference ID/Investigator# 59851

Miyagi, Japan

Location

Site Reference ID/Investigator# 59857

Miyagi, Japan

Location

Site Reference ID/Investigator# 59975

Miyagi, Japan

Location

Site Reference ID/Investigator# 59976

Miyagi, Japan

Location

Site Reference ID/Investigator# 59977

Miyagi, Japan

Location

Site Reference ID/Investigator# 59937

Miyazaki, Japan

Location

Site Reference ID/Investigator# 59913

Nagano, Japan

Location

Site Reference ID/Investigator# 59825

Nagasaki, Japan

Location

Site Reference ID/Investigator# 59814

Nagoya, Japan

Location

Site Reference ID/Investigator# 59936

Nagoya, Japan

Location

Site Reference ID/Investigator# 59927

Nara, Japan

Location

Site Reference ID/Investigator# 59577

Okayama, Japan

Location

Site Reference ID/Investigator# 59567

Osaka, Japan

Location

Site Reference ID/Investigator# 59568

Osaka, Japan

Location

Site Reference ID/Investigator# 59575

Osaka, Japan

Location

Site Reference ID/Investigator# 59815

Osaka, Japan

Location

Site Reference ID/Investigator# 59822

Osaka, Japan

Location

Site Reference ID/Investigator# 59824

Osaka, Japan

Location

Site Reference ID/Investigator# 59829

Osaka, Japan

Location

Site Reference ID/Investigator# 59912

Osaka, Japan

Location

Site Reference ID/Investigator# 59914

Osaka, Japan

Location

Site Reference ID/Investigator# 59915

Osaka, Japan

Location

Site Reference ID/Investigator# 59934

Osaka, Japan

Location

Site Reference ID/Investigator# 59940

Osaka, Japan

Location

Site Reference ID/Investigator# 59573

Saga, Japan

Location

Site Reference ID/Investigator# 59556

Saitama, Japan

Location

Site Reference ID/Investigator# 59925

Saitama, Japan

Location

Site Reference ID/Investigator# 59555

Sapporo, Japan

Location

Site Reference ID/Investigator# 59810

Shiga, Japan

Location

Site Reference ID/Investigator# 59852

Shimane, Japan

Location

Site Reference ID/Investigator# 59855

Suwa, Japan

Location

Site Reference ID/Investigator# 59909

Tochigi, Japan

Location

Site Reference ID/Investigator# 59557

Tokyo, Japan

Location

Site Reference ID/Investigator# 59813

Tokyo, Japan

Location

Site Reference ID/Investigator# 59818

Tokyo, Japan

Location

Site Reference ID/Investigator# 59850

Tokyo, Japan

Location

Site Reference ID/Investigator# 59859

Tokyo, Japan

Location

Site Reference ID/Investigator# 59971

Tokyo, Japan

Location

Site Reference ID/Investigator# 59973

Tokyo, Japan

Location

Site Reference ID/Investigator# 59978

Tokyo, Japan

Location

Site Reference ID/Investigator# 59816

Toyama, Japan

Location

Site Reference ID/Investigator# 59970

Toyama, Japan

Location

Site Reference ID/Investigator# 59811

Wakayama, Japan

Location

Site Reference ID/Investigator# 59856

Yamagata, Japan

Location

Site Reference ID/Investigator# 59926

Yamagata, Japan

Location

Site Reference ID/Investigator# 59817

Yamaguchi, Japan

Location

Site Reference ID/Investigator# 59924

Yamaguchi, Japan

Location

Site Reference ID/Investigator# 59846

Yamanashi, Japan

Location

Site Reference ID/Investigator# 59828

Yokohama, Japan

Location

MeSH Terms

Conditions

Exocrine Pancreatic Insufficiency; Pancreatitis, Chronic

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Pancreatitis; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Toshiaki Yamaguchi, BS Pharm

  Abbott

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 16, 2006
• First Posted: November 17, 2006
• Study Start: May 1, 2007
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: July 28, 2011

Record last verified: 2011-07

Locations

JP (98)