Status:
COMPLETED
Safety and Efficacy of MCC-257 in the Treatment of Diabetic Polyneuropathy
Lead Sponsor:
Tanabe Pharma Corporation
Conditions:
Diabetic Polyneuropathy
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
The primary objectives of the study are to evaluate the efficacy and safety of three doses of MCC-257 in patients with mild to moderate diabetic polyneuropathy
Detailed Description
The study will use a double-blind, randomized, placebo-controlled, fixed-dose, parallel-group design. Patients will be randomized equally to 1 of 4 treatment groups: MCC-257 20 mg, MCC-257 40 mg, MCC-...
Eligibility Criteria
Inclusion
- The patient is male or female, 18-70 years of age
- The patient has either type 1 or type 2 diabetes
- The patient has mild to moderate diabetic neuropathy
- The patient is free from other clinically significant illness or disease, as determined by medical history, physical examination, laboratory evaluations, and other safety tests
Exclusion
- Being treated with anticoagulants other than aspirin, such as warfarin, digoxin, Plavix
- BMI\>40
- A significant disorder or a condition other than diabetes that can cause symptoms or physical conditions that mimic peripheral neuropathy or interfere with cognition
- Any proximal neuropathy, clinically evident nerve entrapment, or any focal trauma potentially affecting nerve function
- Women of childbearing potential who do not refrain from sexual activity or use adequate contraception
- Pregnant or lactating women
- An ALT or AST value \>2X upper limit of normal (ULN)
- Clinically significant cardiovascular disease within the last six (6) months
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2007
Estimated Enrollment :
420 Patients enrolled
Trial Details
Trial ID
NCT00307749
Start Date
March 1 2006
End Date
August 1 2007
Last Update
December 28 2007
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