Safety and Efficacy Study of KAI-1678 to Treat Pain in Subjects With Spinal Cord Injury

August 30, 2011 updated by: KAI Pharmaceuticals

A Double-Blind, Randomized, Placebo-Controlled, Single-Dose Two-Period Crossover Study to Assess the Efficacy of KAI-1678 Administered by Subcutaneous Infusion in Subjects With Spinal Cord Injury

The purpose of this study is to determine whether KAI-1678 is effective in the treatment of pain associated with spinal cord injury.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Sydney, New South Wales, Australia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • spinal cord injury at least 1 year prior and nonprogressive ofr at least 6 months
  • central neuropathic pain for at least 3 months or with relapses and remissions for at least 6 months
  • pain score at least 4 on 11-point numerical rating scale (0-10)
  • stable doses of analgesic medications for at least 1 month

Exclusion Criteria:

  • history of chronic alcoholism or chronic substance abuse
  • tolerance to opioid analgesics
  • clinically significant abnormality on laboratory tests or ECG

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: A1: Placebo
Placebo
Drug: Placebo
Placebo IV Infusion
Experimental: A2: KAI-1678
Experimental
Drug: KAI-1678
KAI-1678 IV Infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The effect of KAI-1678 on mean change from baseline in pain intensity at 6 hours (PID 6).
Time Frame: 6 hours
6 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
The effect of KAI-1678 on the proportion of subjects achieving at least a 1 point improvement in pain intensity at 6 hours
Time Frame: 6 hours
6 hours
The effect of KAI-1678 on patient global impression of change
Time Frame: 6 hours
6 hours
The effect of KAI-1678 on symptoms of neuropathic pain assessed by the Neuropathic Pain Scale (NPS)
Time Frame: 6 hours
6 hours
The number of participants with adverse events as a measure of safety and tolerability of KAI-1678
Time Frame: Two weeks
Two weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

KAI Pharmaceuticals

Collaborators

Trident Clinical Research Pty Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

May 1, 2010

Study Registration Dates

First Submitted

April 16, 2010

First Submitted That Met QC Criteria

June 1, 2010

First Posted (Estimate)

June 2, 2010

Study Record Updates

Last Update Posted (Estimate)

September 1, 2011

Last Update Submitted That Met QC Criteria

August 30, 2011

Last Verified

August 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KAI-1678-004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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