Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of AV411 in Neuropathic Pain

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2007-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetic Neuropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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AV411

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Locations

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University of Adelaide

Adelaide, , Australia

Site Status

Peninsular Specialist Centre

Kipparing, , Australia

Site Status

Countries

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Australia

Other Identifiers

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AV411-010

Identifier Type: -

Identifier Source: org_study_id