Pancreatic Exocrine Insufficiency, Chronic Pancreatitis, PancreatectomyPhase 3NCT00401076
A Open-label Study to Assess the Safety of Oral Long-term Use of SA-001 in Pancreatic Exocrine Insufficiency
A Phase 3 study testing SA-001 in people with Pancreatic Exocrine Insufficiency, Chronic Pancreatitis, Pancreatectomy, run by Abbott at 17 sites in Japan.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Pancreatic Exocrine Insufficiency, Chronic Pancreatitis, Pancreatectomy
- What is being tested?
- SA-001
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 17 sitesJapan
- Study dates
- Jul 2008to Sep 2010
- 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
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.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
Japan17 sites
Site Reference ID/Investigator# 45211
Fukuoka
Site Reference ID/Investigator# 45297
Fukuoka
Site Reference ID/Investigator# 45220
Hiroshima
Site Reference ID/Investigator# 45279
Hiroshima
Site Reference ID/Investigator# 45223
Hokkaido
Site Reference ID/Investigator# 45303
Hokkaido
Site Reference ID/Investigator# 45091
Hyōgo
Site Reference ID/Investigator# 45110
Kanagawa
Site Reference ID/Investigator# 45213
Kanagawa
Site Reference ID/Investigator# 45207
Kyoto
Site Reference ID/Investigator# 45111
Miyagi
Site Reference ID/Investigator# 45282
Miyagi
Site Reference ID/Investigator# 45283
Nagasaki
Site Reference ID/Investigator# 45106
Osaka
Site Reference ID/Investigator# 45242
Sapporo
Site Reference ID/Investigator# 45281
Tokyo
Site Reference ID/Investigator# 45299
Yamaguchi
About this study
Official title: A One-year Open-label Study to Assess the Safety of Oral Long-term Use of SA-001 in Patients With Pancreatic Exocrine Insufficiency Caused by Chronic Pancreatitis or by Pancreatectomy
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.
- Being tested
- SA-001
- Keywords
- SA-001, Pancreatic Exocrine Insufficiency, Chronic Pancreatitis, 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 52 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: SA-001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of long-term use of 3.0 g/day SA 001 (12 capsules/day), flexibly increased or decreased within the range of 1.5 g/day SA 001 (6 capsules/day) to 6.0 g/day SA-001 (24 capsules/day)
Measured: 52 weeks
Secondary outcomes (1)
Efficacy data (nutritional evaluation items) of 3.0 g/day SA-001 (12 capsules/day), flexibly increased or decreased within the range of 1.5 g/day SA 001 (6 capsules/day) to 6.0 g/day SA-001 (24 capsules/day)
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2006 (estimated)
- Study startJul 2008
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Exocrine Insufficiency, Chronic Pancreatitis, PancreatectomyStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Toshiaki Yamaguchi, BS Pharm, Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00401076
- Sponsor's protocol ID
- S245.3.123
- Status last verified
- Jul 2011
- First submitted
- 16 Nov 2006
- Last updated
- 1 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A One-year Open-label Study to Assess the Safety of Oral Long-term Use of SA-001 in Patients With Pancreatic Exocrine Insufficiency Caused by Chronic Pancreatitis or by Pancreatectomy
- ClinicalTrials.gov ID
- NCT00401076
- Acronym / sponsor ID
- S245.3.123
- Keywords
- SA-001, Pancreatic Exocrine Insufficiency, Chronic Pancreatitis, Pancreatectomy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Study start
- Jul 2008
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: SA-001 |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 52 weeks | Drug | 1 |
Primary outcome
Safety of long-term use of 3.0 g/day SA 001 (12 capsules/day), flexibly increased or decreased within the range of 1.5 g/day SA 001 (6 capsules/day) to 6.0 g/day SA-001 (24 capsules/day)
Time frame: 52 weeks
1 secondary outcome
Efficacy data (nutritional evaluation items) of 3.0 g/day SA-001 (12 capsules/day), flexibly increased or decreased within the range of 1.5 g/day SA 001 (6 capsules/day) to 6.0 g/day SA-001 (24 capsules/day)
Time frame: 52 weeks
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 1 Aug 2011.
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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
17 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 Pancreatic Exocrine Insufficiency, Chronic Pancreatitis, Pancreatectomy, run by Abbott at 17 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?
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 1 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 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. 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?
Safety of long-term use of 3.0 g/day SA 001 (12 capsules/day), flexibly increased or decreased within the range of 1.5 g/day SA 001 (6 capsules/day) to 6.0 g/day SA-001 (24 capsules/day) (time frame: 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Aug 2011.