Status:
COMPLETED
Safety and Efficacy of AS-3201 in the Treatment of Diabetic Sensorimotor Polyneuropathy
Lead Sponsor:
Sumitomo Pharma Co., Ltd.
Conditions:
Diabetic Neuropathy
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
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.
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
End Date :
September 1 2006
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT00101426
Start Date
October 1 2004
End Date
September 1 2006
Last Update
January 14 2008
Active Locations (1)
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1
Toronto General Hospital, University Health Network
Toronto, Ontario, Canada, M5G 2C4