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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00576277
Other study ID # AV411-010
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received December 17, 2007
Last updated December 17, 2007
Start date September 2006
Est. completion date November 2007

Study information

Verified date April 2007
Source Avigen
Contact n/a
Is FDA regulated No
Health authority Australia: Human Research Ethics Committee
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
AV411


Locations

Country Name City State
Australia University of Adelaide Adelaide
Australia Peninsular Specialist Centre Kipparing

Sponsors (1)

Lead Sponsor Collaborator
Avigen

Country where clinical trial is conducted

Australia, 

Outcome

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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