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

Diabetic Neuropathy Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00101426
• Other study ID #: AS-3201-253
• Status: Completed
• Phase: Phase 3
• First received: January 10, 2005
• Last updated: January 10, 2008
• Start date: October 2004
• Est. completion date: September 2006

Study information

• Verified date: January 2008
• Source: Sumitomo Dainippon Pharma Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: September 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Diabetic Neuropathy
• Polyneuropathies

Intervention

Drug:
• ranirestat, (AS-3201)

Locations

Country	Name	City	State
Canada	Toronto General Hospital, University Health Network	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Sumitomo Dainippon Pharma Co., Ltd.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy
Secondary	Safety