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

• Status: Completed
• Trial end date: 2006-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sumitomo Dainippon Pharma Co., Ltd.
• Treatments: Ranirestat

Criteria

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