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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00101426
Recruitment Status : Completed
First Posted : January 11, 2005
Last Update Posted : January 14, 2008
Information provided by:
Sumitomo Dainippon 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.

Condition or disease Intervention/treatment Phase
Diabetic Neuropathy Drug: ranirestat, (AS-3201) Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Study Start Date : October 2004
Estimated Study Completion Date : September 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Efficacy

Secondary Outcome Measures :
  1. Safety

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00101426

Canada, Ontario
Toronto General Hospital, University Health Network
Toronto, Ontario, Canada, M5G 2C4
Sponsors and Collaborators
Sumitomo Dainippon Pharma Co., Ltd.

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00101426     History of Changes
Other Study ID Numbers: AS-3201-253
First Posted: January 11, 2005    Key Record Dates
Last Update Posted: January 14, 2008
Last Verified: January 2008

Keywords provided by Sumitomo Dainippon Pharma Co., Ltd.:
Diabetic sensorimotor polyneuropathy
Diabetic Neuropathy

Additional relevant MeSH terms:
Diabetic Neuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases