- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00101426
Safety and Efficacy of AS-3201 in the Treatment of Diabetic Sensorimotor Polyneuropathy
January 10, 2008 updated by: Sumitomo Pharma Co., Ltd.
This is a safety and efficacy trial of ranirestat(AS-3201) which is an aldose reductase inhibitor in patients with diabetic sensorimotor polyneuropathy.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment
500
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ontario
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Toronto, Ontario, Canada, M5G 2C4
- Toronto General Hospital, University Health Network
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Efficacy
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Secondary Outcome Measures
Outcome Measure |
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Safety
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2004
Study Completion
September 1, 2006
Study Registration Dates
First Submitted
January 10, 2005
First Submitted That Met QC Criteria
January 10, 2005
First Posted (Estimate)
January 11, 2005
Study Record Updates
Last Update Posted (Estimate)
January 14, 2008
Last Update Submitted That Met QC Criteria
January 10, 2008
Last Verified
January 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AS-3201-253
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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University of PittsburghUniversity of Texas Southwestern Medical CenterCompletedAdolescent BehaviorUnited States
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