Diabetic Polyneuropathy Clinical Trial
Official title:
A Phase II, Randomized, Double-Blind, Placebo-Controlled, 24-Week Dose Finding Study to Evaluate the Efficacy and Safety of 20mg, 40mg and 80mg of MCC-257 in Patients With Mild to Moderate Diabetic Polyneuropathy
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
Status | Completed |
Enrollment | 420 |
Est. completion date | August 2007 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Mitsubishi Tanabe Pharma Corporation |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Nerve Conduction Studies | Day 1, Week 24 | ||
Secondary | Nerve fiber density | Day 1, Week 24 | ||
Secondary | QST | Day 1, Week 12, Week 24 | ||
Secondary | Symptom | Day 1, Week 12, Week 24 | ||
Secondary | Clinical Global Impression | Week 12, Week 24 |
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