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

Phase 3

Completed

• Conditions: Diabetic Neuropathy

• Registration Number: NCT00101426
• Lead Sponsor: Sumitomo Pharma Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-10
• Study First Submitted: 2005-01-10
• Study First Submitted QC: 2005-01-10
• Study First Posted: 2005-01-11
• Study Completion: 2006-09
• Status Verified: 2008-01
• Last Update Submitted: 2008-01-10
• Last Update Posted: 2008-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Efficacy

Secondary Outcome Measures

Name	Time	Method
Safety

Trial Locations

Locations (1)

Toronto General Hospital, University Health Network; 🇨🇦 Toronto, Ontario, Canada