Diabetic Neuropathy Clinical Trial
Official title:
A Prospective, Double-Blind, Randomized, Placebo-Controlled Trial of AV411 to Assess Its Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy in the Treatment of Neuropathic Pain
Verified date | April 2007 |
Source | Avigen |
Contact | n/a |
Is FDA regulated | No |
Health authority | Australia: Human Research Ethics Committee |
Study type | Interventional |
The purpose of this study is to determine the safety, tolerability and pharmacokinetics of AV411 after single and multiple doses in patients with chronic neuropathic pain due to diabetes.
Status | Completed |
Enrollment | 36 |
Est. completion date | November 2007 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: - Diagnosis of diabetic neuropathy or complex regional pain syndrome of at least 6 months duration - VAS score of 4 cm or higher at Screening - No clinical abnormality in laboratory and urine analyses - Electrocardiogram within normal limits at Screening - Negative pregnancy test on Study Day 1 for female subjects of childbearing potential - On stable doses of medications, analgesic or others for at least 8 weeks prior to study enrollment - Willing to use barrier contraceptive during the period of the study Exclusion Criteria: - Known hypersensitivity to AV411 or its components - Conditions which might affect drug absorption, metabolism or excretion - Untreated mental illness, current drug addiction or abuse or alcoholism - Donated blood in the past 90 days or have poor peripheral venous access - Platelets <100,000mm3 or a history of thrombocytopenia - Known or suspected chronic liver disease - GFR <=90mL/min/1.73m2 (Cockcroft-Gault) - Female subjects who are pregnant or nursing mothers - Received an investigational drug in the past 90 days - Unable to swallow large capsules |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Australia | University of Adelaide | Adelaide | |
Australia | Peninsular Specialist Centre | Kipparing |
Lead Sponsor | Collaborator |
---|---|
Avigen |
Australia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety | |||
Primary | Tolerability | |||
Primary | Pharmacokinetic profile | |||
Primary | Pharmacodynamic profile | |||
Secondary | Brief Pain Inventory | |||
Secondary | Visual Analog Scale | |||
Secondary | Clinical Global Impression of Change | |||
Secondary | Use of analgesic or adjuvant medications for neuropathic pain | |||
Secondary | Correlation between plasma concentrations of AV411 and pain intensity assessments |
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