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Clinical Trials/NCT00101426
NCT00101426CompletedPhase 3

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

Sumitomo Pharma Co., Ltd.2 sites in 1 country500 target enrollmentStarted: October 1, 2004Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 3
Status
Completed
Enrollment
500
Locations
2
Primary Endpoint
Efficacy
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double

Eligibility Criteria

Ages
18 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Efficacy

Secondary Outcomes

  • Safety

Investigators

Sponsor Class
Industry

Study Sites (2)

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