Safety and Efficacy of AS-3201 in the Treatment of Diabetic Sensorimotor Polyneuropathy
1 other identifier
interventional
500
1 country
1
Brief Summary
This is a safety and efficacy trial of ranirestat(AS-3201) which is an aldose reductase inhibitor in patients with diabetic sensorimotor polyneuropathy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Oct 2004
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2004
CompletedFirst Submitted
Initial submission to the registry
January 10, 2005
CompletedFirst Posted
Study publicly available on registry
January 11, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2006
CompletedJanuary 14, 2008
January 1, 2008
January 10, 2005
January 10, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Efficacy
Secondary Outcomes (1)
Safety
Interventions
Eligibility Criteria
You may qualify if:
- 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.
- 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
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Toronto General Hospital, University Health Network
Toronto, Ontario, M5G 2C4, Canada
Related Publications (1)
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.
PMID: 19366965DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
January 10, 2005
First Posted
January 11, 2005
Study Start
October 1, 2004
Study Completion
September 1, 2006
Last Updated
January 14, 2008
Record last verified: 2008-01