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

NCT ID: NCT00101426

Last Updated: 2008-01-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-10-31
• Study Completion Date: 2006-09-30

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.

Conditions

Diabetic Neuropathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

ranirestat, (AS-3201)

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sumitomo Pharma Co., Ltd.

INDUSTRY

Sponsor Role: lead

Locations

Toronto General Hospital, University Health Network

Toronto, Ontario, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 19366965 (View on PubMed)

Other Identifiers

AS-3201-253

Identifier Type: -

Identifier Source: org_study_id