Diabetic NeuropathyPhase 3NCT00101426
Safety and Efficacy of AS-3201 in the Treatment of Diabetic Sensorimotor Polyneuropathy
A Phase 3 study testing ranirestat, (AS-3201) in people with Diabetic Neuropathy, run by Sumitomo Pharma Co., Ltd. at 1 site in Canada.
Trial summary
This is a safety and efficacy trial of ranirestat(AS-3201) which is an aldose reductase inhibitor in patients with diabetic sensorimotor polyneuropathy. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetic Neuropathy
- What is being tested?
- ranirestat, (AS-3201)
- How many people
- 500 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2004to Sep 2006
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with the following may enter:
- Clinical signs and symptoms (footpain, numbness, tingling, weakness, etc.) of symmetrical distal Diabetic Sensorimotor Polyneuropathy with diagnosis by Nerve Conduction Tests and/or Quantitative Sensory Test.
- 18 to 70 years old of either sex and any race
- Type I or Type II, insulin-dependent or non insulin-dependent diabetes for at least six months prior to study entry
- Healthy in general
- No hospitalizations for diabetic control or episodes of ketoacidosis for three months prior to screening
- Female patients of childbearing potential must have a negative serum pregnancy test
Who cannot join
- Known non-diabetic causes of neuropathic symptoms
- Diabetic patients with no neuropathy or severe neuropathy
- Used any Aldose Reductase Inhibitors within one year of screening
- Clinically significant illness including unstable cardiac, pulmonary, hematologic, hepatic, renal, or neoplastic disease
- A history of systemic carcinoma within five years of screening
- A history of epilepsy or serious head injury
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- A history or evidence of drug or alcohol abuse
- Test positive at screening for hepatitis B surface antigen or hepatitis C antibody or have a history of a positive result, or patients with evidence of significant hepatic insufficiency
- A history of known or suspected diagnosis of AIDS, or have tested seropositive for HIV antibody or antigen previously
Trial locations and contacts
1 site in 1 country.
Canada1 site
Toronto General Hospital, University Health Network
Toronto, Ontario, M5G 2C4
About this study
This is a safety and efficacy trial of ranirestat(AS-3201) which is an aldose reductase inhibitor in patients with diabetic sensorimotor polyneuropathy.
- Conditions
- Diabetic Neuropathy
- Being tested
- ranirestat, (AS-3201)
- Keywords
- Diabetic sensorimotor polyneuropathy, Diabetic Neuropathy
- Medical subject headings
- Diabetic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ranirestat, (AS-3201)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy
Secondary outcomes (1)
Safety
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2005 (estimated)
- Study startOct 2004
- Study completionSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetic NeuropathyStudies 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
- Enrolment
- 500 participants
Sponsor and investigators
- Lead sponsor
- Sumitomo Pharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00101426
- Sponsor's protocol ID
- AS-3201-253
- Status last verified
- Jan 2008
- First submitted
- 10 Jan 2005
- Last updated
- 14 Jan 2008
- Results posted
- No
Publications
Bril V, Hirose T, Tomioka S, Buchanan R; Ranirestat Study Group. Ranirestat for the management of diabetic sensorimotor polyneuropathy. Diabetes Care. 2009 Jul;32(7):1256-60. doi: 10.2337/dc08-2110. Epub 2009 Apr 14.
PubMed 19366965
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of AS-3201 in the Treatment of Diabetic Sensorimotor Polyneuropathy
- ClinicalTrials.gov ID
- NCT00101426
- Acronym / sponsor ID
- AS-3201-253
- Conditions
- Diabetic Neuropathy
- Keywords
- Diabetic sensorimotor polyneuropathy, Diabetic Neuropathy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants
- Lead sponsor
- Sumitomo Pharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Oct 2004
- Study completion
- Sep 2006
- First posted
- 11 Jan 2005 (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 is a safety and efficacy trial of ranirestat(AS-3201) which is an aldose reductase inhibitor in patients with diabetic sensorimotor polyneuropathy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with the following may enter:
- Clinical signs and symptoms (footpain, numbness, tingling, weakness, etc.) of symmetrical distal Diabetic Sensorimotor Polyneuropathy with diagnosis by Nerve Conduction Tests and/or Quantitative Sensory Test.
- 18 to 70 years old of either sex and any race
- Type I or Type II, insulin-dependent or non insulin-dependent diabetes for at least six months prior to study entry
- Healthy in general
Key exclusion criteria (9 listed)
- Known non-diabetic causes of neuropathic symptoms
- Diabetic patients with no neuropathy or severe neuropathy
- Used any Aldose Reductase Inhibitors within one year of screening
- Clinically significant illness including unstable cardiac, pulmonary, hematologic, hepatic, renal, or neoplastic disease
- A history of systemic carcinoma within five years of screening
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 |
|---|---|---|
| ranirestat, (AS-3201) | Drug | – |
Primary outcome
Efficacy
1 secondary outcome
Safety
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 14 Jan 2008.
- Derived from this study: PubMed 19366965Bril V, Hirose T, Tomioka S, Buchanan R; Ranirestat Study Group. Ranirestat for the management of diabetic sensorimotor polyneuropathy. Diabetes Care. 2009 Jul;32(7):1256-60. doi: 10.2337/dc08-2110. Epub 2009 Apr 14.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ranirestat, (AS-3201) in people with Diabetic Neuropathy, run by Sumitomo Pharma Co., Ltd. at 1 site in Canada.
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 7 inclusion and 9 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 14 Jan 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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?
Efficacy. 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 NCT00101426, which also lists 1 linked publication.
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 14 Jan 2008.