Status:
COMPLETED
Evaluating the Efficacy and Safety of Oral Ranirestat (40 and 80 mg) in Mild to Moderate Diabetic Sensorimotor Polyneuropathy
Lead Sponsor:
Eisai Inc.
Conditions:
Mild to Moderate Diabetic Sensorimotor Polyneuropathy
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
PHASE3
Brief Summary
The purpose of this study is to determine the effect of 40 mg and 80 mg ranirestat on peroneal motor nerve conduction velocity relative to placebo in subjects with mild to moderate diabetic sensorimot...
Eligibility Criteria
Inclusion
- Subjects with Type 1 or Type 2, insulin-dependent or non insulin-dependent diabetes mellitus.
- Subjects with a history of distal symmetric polyneuropathy, secondary to diabetes, diagnosed in accordance with the American Academy of Neurology criteria.
- Female subjects, who are of non-reproductive potential (\>=12 months post-menopausal or surgically sterile) or who are using adequate contraception which includes abstinence or double barrier methods (diaphragm and condom with spermicidal cream, intrauterine device and condom with spermicidal cream). Male subjects with partners of child-bearing potential must also use adequate contraception.
- Subjects must be able to read, understand, and provide written informed consent before enrolling in the study at screening.
Exclusion
- History of diabetic foot ulcers or lower extremity amputation.
- Diabetic amyotrophy or non-diabetic cause of lower limb neuropathy/neuropathic symptoms.
- Clinically significant illness which, in the opinion of the investigator, would compromise a subject's suitability to participate in the study for reasons of safety or would confound the efficacy assessments.
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2013
Estimated Enrollment :
800 Patients enrolled
Trial Details
Trial ID
NCT00927914
Start Date
July 1 2009
End Date
February 1 2013
Last Update
February 21 2019
Active Locations (1)
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1
The Johns Hopkins Hospital
Baltimore, Maryland, United States, 21231