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

This study has been completed.
Sponsor:
Information provided by:
Dainippon Sumitomo Pharma
ClinicalTrials.gov Identifier:
NCT00101426
First received: January 10, 2005
Last updated: January 10, 2008
Last verified: January 2008
History of Changes
  Purpose

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Dainippon Sumitomo Pharma:

Primary Outcome Measures:
  • Efficacy

Secondary Outcome Measures:
  • Safety

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00101426

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

No publications provided by Dainippon Sumitomo Pharma

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00101426     History of Changes
Other Study ID Numbers: AS-3201-253
Study First Received: January 10, 2005
Last Updated: January 10, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Dainippon Sumitomo Pharma:
Diabetic sensorimotor polyneuropathy
Diabetic Neuropathy

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

ClinicalTrials.gov processed this record on June 18, 2013