Evaluating the Efficacy and Safety of Oral Ranirestat (40 and 80 mg) in Mild to Moderate Diabetic Sensorimotor Polyneuropathy
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|ClinicalTrials.gov Identifier: NCT00927914|
Recruitment Status : Completed
First Posted : June 25, 2009
Last Update Posted : December 16, 2015
|Condition or disease||Intervention/treatment||Phase|
|Mild to Moderate Diabetic Sensorimotor Polyneuropathy.||Drug: Ranirestat Drug: Placebo||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||800 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A 2-year, Randomized, Double-blind, Placebo-controlled, Multi-center, Phase II-III Study to Evaluate the Efficacy and Safety of Oral Ranirestat (40 and 80 mg) in Mild to Moderate Diabetic Sensorimotor Polyneuropathy|
|Study Start Date :||July 2009|
|Actual Primary Completion Date :||January 2013|
|Actual Study Completion Date :||February 2013|
Experimental: Ranirestat 80 mg
Two 80 mg Ranirestat tablets, given orally, once daily, preferably in the morning with or without a light breakfast, for upto 24 months.
Ranirestat 40 mg tablets
Experimental: Ranirestat 40 mg
One 40 mg tablet of Ranirestat and a matching placebo, given orally, once daily, preferably in the morning with or without a light breakfast, for upto 24 months.
Ranirestat 40 mg tabletsDrug: Placebo
Placebo Comparator: Placebo
Two placebo tablets, given orally, once daily, preferably in the morning with or without a light breakfast, for upto 24 months.
- Peroneal motor nerve conduction velocity: the mean of duplicate bilateral recordings made within 1-21 days of each other. [ Time Frame: 24 months ]
- Neuropathy total symptom score-6 via a self-administered questionnaire and vibration perception threshold recorded with a neurothesiometer. [ Time Frame: 24 months ]
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 ClinicalTrials.gov identifier (NCT number): NCT00927914
|United States, Maryland|
|The Johns Hopkins Hospital|
|Baltimore, Maryland, United States, 21231|
|Study Director:||Roderick Junor||Eisai Limited|