NCT00576277

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Sep 2006

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 17, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 19, 2007

Completed
Last Updated

December 19, 2007

Status Verified

April 1, 2007

First QC Date

December 17, 2007

Last Update Submit

December 17, 2007

Conditions

Diabetic Neuropathy

Outcome Measures

Primary Outcomes (4)

  • Safety

  • Tolerability

  • Pharmacokinetic profile

  • Pharmacodynamic profile

Secondary Outcomes (5)

  • Brief Pain Inventory

  • Visual Analog Scale

  • Clinical Global Impression of Change

  • Use of analgesic or adjuvant medications for neuropathic pain

  • Correlation between plasma concentrations of AV411 and pain intensity assessments

Interventions

AV411DRUG

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Adelaide

Adelaide, Australia

Location

Peninsular Specialist Centre

Kipparing, Australia

Location

MeSH Terms

Conditions

Diabetic Neuropathies

Interventions

ibudilast

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 17, 2007

First Posted

December 19, 2007

Study Start

September 1, 2006

Study Completion

November 1, 2007

Last Updated

December 19, 2007

Record last verified: 2007-04

Locations

AU(2)