This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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

This study has been completed.
Information provided by:
Sumitomo Dainippon Pharma Co., Ltd. Identifier:
First received: January 10, 2005
Last updated: January 10, 2008
Last verified: January 2008
This is a safety and efficacy trial of ranirestat(AS-3201) which is an aldose reductase inhibitor in patients with diabetic sensorimotor polyneuropathy.

Condition Intervention Phase
Diabetic Neuropathy Drug: ranirestat, (AS-3201) Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Sumitomo Dainippon Pharma Co., Ltd.:

Primary Outcome Measures:
  • Efficacy

Secondary Outcome Measures:
  • Safety

Estimated Enrollment: 500
Study Start Date: October 2004
Estimated Study Completion Date: September 2006

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00101426

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

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00101426     History of Changes
Other Study ID Numbers: AS-3201-253
Study First Received: January 10, 2005
Last Updated: January 10, 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 processed this record on June 23, 2017