Exocrine Pancreatic Insufficiency, Chronic PancreatitisPhase 3NCT00400842

A Study of SA-001 to Treat Pancreatic Exocrine Insufficiency

A Phase 3 study testing SA-001 in people with Exocrine Pancreatic Insufficiency, Chronic Pancreatitis, run by Abbott at 98 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 20 years and older
Conditions the study is for: Exocrine Pancreatic Insufficiency, Chronic Pancreatitis
What is being tested?: SA-001
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 274 participants
Where: 98 sitesJapan
Study dates: May 2007to Aug 2009
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

98 sites in 1 country.

City, postcode or hospital

98 sites in 1 country

Japan98 sites

Site Reference ID/Investigator# 59845
Aichi
Site Reference ID/Investigator# 59933
Aichi
Site Reference ID/Investigator# 59928
Akita
Site Reference ID/Investigator# 59983
Amori
Site Reference ID/Investigator# 59984
Amori
Site Reference ID/Investigator# 59569
Ehime
Site Reference ID/Investigator# 59938
Ehime
Site Reference ID/Investigator# 59571
Fukuoka
Site Reference ID/Investigator# 59572
Fukuoka
Site Reference ID/Investigator# 59812
Fukuoka
Site Reference ID/Investigator# 59826
Fukuoka
Site Reference ID/Investigator# 59848
Fukuoka
Site Reference ID/Investigator# 59922
Fukuoka
Site Reference ID/Investigator# 59923
Fukuoka
Site Reference ID/Investigator# 59980
Fukuoka
Site Reference ID/Investigator# 59932
Fukushima
Site Reference ID/Investigator# 59935
Fukushima
Site Reference ID/Investigator# 59930
Higashiibaraki
Site Reference ID/Investigator# 59929
Hiroshima
Site Reference ID/Investigator# 59968
Hiroshima
Site Reference ID/Investigator# 59972
Hiroshima
Site Reference ID/Investigator# 59827
Hokkaido
Site Reference ID/Investigator# 59939
Hokkaido
Site Reference ID/Investigator# 59969
Hokkaido
Site Reference ID/Investigator# 59974
Hokkaido
Site Reference ID/Investigator# 59981
Hokkaido
Site Reference ID/Investigator# 59982
Hokkaido
Site Reference ID/Investigator# 59576
Hyōgo
Site Reference ID/Investigator# 59830
Hyōgo
Site Reference ID/Investigator# 59847
Hyōgo
Site Reference ID/Investigator# 59907
Hyōgo
Site Reference ID/Investigator# 59908
Hyōgo
Site Reference ID/Investigator# 59566
Ishikawa
Site Reference ID/Investigator# 59911
Ishikawa
Site Reference ID/Investigator# 59931
Kagoshima
Site Reference ID/Investigator# 59564
Kanagawa
Site Reference ID/Investigator# 59565
Kanagawa
Site Reference ID/Investigator# 59819
Kanagawa
Site Reference ID/Investigator# 59820
Kanagawa
Site Reference ID/Investigator# 59823
Kanagawa
Site Reference ID/Investigator# 59844
Kanagawa
Site Reference ID/Investigator# 59858
Kanagawa
Site Reference ID/Investigator# 59570
Kouchi
Site Reference ID/Investigator# 59574
Kumamoto
Site Reference ID/Investigator# 59854
Kurihara
Site Reference ID/Investigator# 59821
Kyoto
Site Reference ID/Investigator# 59910
Mie
Site Reference ID/Investigator# 59979
Mie
Site Reference ID/Investigator# 59849
Miyagi
Site Reference ID/Investigator# 59851
Miyagi
Site Reference ID/Investigator# 59857
Miyagi
Site Reference ID/Investigator# 59975
Miyagi
Site Reference ID/Investigator# 59976
Miyagi
Site Reference ID/Investigator# 59977
Miyagi
Site Reference ID/Investigator# 59937
Miyazaki
Site Reference ID/Investigator# 59913
Nagano
Site Reference ID/Investigator# 59825
Nagasaki
Site Reference ID/Investigator# 59814
Nagoya
Site Reference ID/Investigator# 59936
Nagoya
Site Reference ID/Investigator# 59927
Nara
Site Reference ID/Investigator# 59577
Okayama
Site Reference ID/Investigator# 59567
Osaka
Site Reference ID/Investigator# 59568
Osaka
Site Reference ID/Investigator# 59575
Osaka
Site Reference ID/Investigator# 59815
Osaka
Site Reference ID/Investigator# 59822
Osaka
Site Reference ID/Investigator# 59824
Osaka
Site Reference ID/Investigator# 59829
Osaka
Site Reference ID/Investigator# 59912
Osaka
Site Reference ID/Investigator# 59914
Osaka
Site Reference ID/Investigator# 59915
Osaka
Site Reference ID/Investigator# 59934
Osaka
Site Reference ID/Investigator# 59940
Osaka
Site Reference ID/Investigator# 59573
Saga
Site Reference ID/Investigator# 59556
Saitama
Site Reference ID/Investigator# 59925
Saitama
Site Reference ID/Investigator# 59555
Sapporo
Site Reference ID/Investigator# 59810
Shiga
Site Reference ID/Investigator# 59852
Shimane
Site Reference ID/Investigator# 59855
Suwa
Site Reference ID/Investigator# 59909
Tochigi
Site Reference ID/Investigator# 59557
Tokyo
Site Reference ID/Investigator# 59813
Tokyo
Site Reference ID/Investigator# 59818
Tokyo
Site Reference ID/Investigator# 59850
Tokyo
Site Reference ID/Investigator# 59859
Tokyo
Site Reference ID/Investigator# 59971
Tokyo
Site Reference ID/Investigator# 59973
Tokyo
Site Reference ID/Investigator# 59978
Tokyo
Site Reference ID/Investigator# 59816
Toyama
Site Reference ID/Investigator# 59970
Toyama
Site Reference ID/Investigator# 59811
Wakayama
Site Reference ID/Investigator# 59856
Yamagata
Site Reference ID/Investigator# 59926
Yamagata
Site Reference ID/Investigator# 59817
Yamaguchi
Site Reference ID/Investigator# 59924
Yamaguchi
Site Reference ID/Investigator# 59846
Yamanashi
Site Reference ID/Investigator# 59828
Yokohama

Other trials in Japan

About this study

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

Conditions: Exocrine Pancreatic Insufficiency, Chronic Pancreatitis
Being tested: SA-001, Placebo
Keywords: SA-001, Pancreatic Exocrine Insufficiency, Pancreatectomy
Medical subject headings: Exocrine Pancreatic Insufficiency, Pancreatitis, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SA-001Drug
0.25 g of SA-001 pellets/capsule, 12 capsules/day for 7 days
SA-001Drug
0.25 g of SA-001 pellets/capsule, 6 capsules/day for 7 days
PlaceboDrug
Placebo

Study groups in NCT00400842
Study group	Role	What they receive
L	Experimental	Not described Receives: Drug: SA-001
H	Experimental	Not described Receives: Drug: SA-001
P	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in CFA from baseline to the end of double-blind treatment
Measured: 7 days after baseline

Secondary outcomes (1)

Stool fat excretion, stool weight, stool frequency, nutritional parameters
Measured: 7 days after baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2007Aug 2009

First posted17 Nov 2006 (estimated)
Study startMay 2007
Primary completionAug 2009
Study completionAug 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Exocrine Pancreatic Insufficiency, Chronic PancreatitisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 274 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00400842
Sponsor's protocol ID: S245.3.122
Status last verified: Jul 2011
First submitted: 16 Nov 2006
Last updated: 28 Jul 2011
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 3
Comparative Study to Evaluate Microbial Versus Porcine Pancreatic Enzyme Therapy in Chronic Pancreatitis
Pancreatitis, Chronic, Exocrine Pancreatic Insufficiency (EPI)
Active, not recruitingPhase 4
A Study Of Effect Of Secretin For In Injection (Chirostim) On Pancreatic Fluid Composition In Healthy Subjects
Exocrine Pancreatic Insufficiency, Chronic Pancreatitis
RecruitingPhase 4
Malabsorption Blood Test (MBT) to Determine Exocrine Pancreatic Function and Related Quality of Life in Chronic Pancreatitis
Chronic Pancreatitis, Recurrent Acute Pancreatitis
Not yet recruitingObservational study
Breath Test-Based Assessment of SIBO in Chronic Pancreatitis and Partial Pancreatectomy
SIBO, Pancreatic Insufficiency
RecruitingEarly Phase 1
A Study on the Changes of Glucose Metabolism and Exocrine Function in Patients With Chronic Pancreatitis
Chronic Pancreatitis Pancreatic Exocrine Insufficiency Blood Glucose

All Exocrine Pancreatic Insufficiency, Chronic Pancreatitis trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00400842
Acronym / sponsor ID: S245.3.122
Conditions: Exocrine Pancreatic Insufficiency, Chronic Pancreatitis
Keywords: SA-001, Pancreatic Exocrine Insufficiency, Pancreatectomy
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 274 participants (actual)
Lead sponsor: AbbottIndustry (pharma, biotech, devices)
Study start: May 2007
Primary completion: Aug 2009 (actual)
Study completion: Aug 2009 (actual)
First posted: 17 Nov 2006 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
L	Experimental	Drug: SA-001
H	Experimental	Drug: SA-001
P	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SA-0010.25 g of SA-001 pellets/capsule, 12 capsules/day for 7 days	Drug	L
SA-0010.25 g of SA-001 pellets/capsule, 6 capsules/day for 7 days	Drug	H
PlaceboPlacebo	Drug	P

Primary outcome

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

1 secondary outcome

Stool fat excretion, stool weight, stool frequency, nutritional parameters
Time frame: 7 days after baseline

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2011.

Related trials for Exocrine Pancreatic Insufficiency, Chronic Pancreatitis

RecruitingPhase 3
Comparative Study to Evaluate Microbial Versus Porcine Pancreatic Enzyme Therapy in Chronic Pancreatitis
Pancreatitis, Chronic, Exocrine Pancreatic Insufficiency (EPI)
Active, not recruitingPhase 4
A Study Of Effect Of Secretin For In Injection (Chirostim) On Pancreatic Fluid Composition In Healthy Subjects
Exocrine Pancreatic Insufficiency, Chronic Pancreatitis
RecruitingPhase 4
Malabsorption Blood Test (MBT) to Determine Exocrine Pancreatic Function and Related Quality of Life in Chronic Pancreatitis
Chronic Pancreatitis, Recurrent Acute Pancreatitis
Not yet recruitingObservational study
Breath Test-Based Assessment of SIBO in Chronic Pancreatitis and Partial Pancreatectomy
SIBO, Pancreatic Insufficiency
RecruitingEarly Phase 1
A Study on the Changes of Glucose Metabolism and Exocrine Function in Patients With Chronic Pancreatitis
Chronic Pancreatitis Pancreatic Exocrine Insufficiency Blood Glucose

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Toshiaki Yamaguchi, BS Pharm study director

Abbott

98 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing SA-001 in people with Exocrine Pancreatic Insufficiency, Chronic Pancreatitis, run by Abbott at 98 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 98 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in CFA from baseline to the end of double-blind treatment (time frame: 7 days after baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00400842.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2011.