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

Primary Purpose

Spinal Cord Injury

Status
Completed
Phase
Phase 2
Locations
Australia
Study Type
Interventional
Intervention
Placebo
KAI-1678
Sponsored by
KAI Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injury focused on measuring Analgesics. Non-narcotic / therapeutic use, Spinal Cord Injuries, Pain, Pain measurement / drug effect, Pain postoperative / drug therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

A1: Placebo

A2: KAI-1678

Arm Description

Placebo

Experimental

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
April 16, 2010
Last Updated
August 30, 2011
Sponsor
KAI Pharmaceuticals
Collaborators
Trident Clinical Research Pty Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT01135108
Brief Title
Safety and Efficacy Study of KAI-1678 to Treat Pain in Subjects With Spinal Cord Injury
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
May 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
KAI Pharmaceuticals
Collaborators
Trident Clinical Research Pty Ltd

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury
Keywords
Analgesics. Non-narcotic / therapeutic use, Spinal Cord Injuries, Pain, Pain measurement / drug effect, Pain postoperative / drug therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A1: Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Arm Title
A2: KAI-1678
Arm Type
Experimental
Arm Description
Experimental
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo IV Infusion
Intervention Type
Drug
Intervention Name(s)
KAI-1678
Intervention Description
KAI-1678 IV Infusion
Primary Outcome Measure Information:
Title
The effect of KAI-1678 on mean change from baseline in pain intensity at 6 hours (PID 6).
Time Frame
6 hours
Secondary Outcome Measure Information:
Title
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
Title
The effect of KAI-1678 on patient global impression of change
Time Frame
6 hours
Title
The effect of KAI-1678 on symptoms of neuropathic pain assessed by the Neuropathic Pain Scale (NPS)
Time Frame
6 hours
Title
The number of participants with adverse events as a measure of safety and tolerability of KAI-1678
Time Frame
Two weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregory Bell, MD
Organizational Affiliation
KAI Pharmaceuticals, Inc
Official's Role
Study Director
Facility Information:
City
Sydney
State/Province
New South Wales
Country
Australia

12. IPD Sharing Statement

Learn more about this trial

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

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