Safety and Efficacy of AS-3201 in the Treatment of Diabetic Sensorimotor Polyneuropathy

Sumitomo Pharma

Status and phase

Completed

Phase 3

Conditions

Diabetic Neuropathy

Treatments

Drug: ranirestat, (AS-3201)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00101426

AS-3201-253

Details and patient eligibility

About

This is a safety and efficacy trial of ranirestat(AS-3201) which is an aldose reductase inhibitor in patients with diabetic sensorimotor polyneuropathy.

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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