Back to resultsSafety and Efficacy Study of KAI-1678 to Treat Pain in Subjects With Postherpetic Neuralgia
Primary Purpose
Postherpetic Neuralgia
Status
Completed
Phase
Phase 2
Locations
Australia
Study Type
Interventional
Intervention
Placebo
KAI-1678
Lidocaine
Sponsored by
About this trial
This is an interventional treatment trial for Postherpetic Neuralgia focused on measuring Lidocaine, Lignocaine, Analgesics. Non-narcotic / therapeutic use, Neuralgia, Postherpetic, Pain, Pain measurement / drug effect, Pain postoperative / drug therapy, PHN
Eligibility Criteria
Inclusion Criteria:
- diagnosis of PHN with pain for at least 3 months after segmental herpes zoster eruption
- 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:
- diagnosis of PHN with pain for at least 3 months after segmental herpes zoster eruption
- pain score at least 4 on 11-point numerical rating scale (0-10)
- stable doses of analgesic medications for at least 1 month"
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Experimental
Active Comparator
Arm Label
A1: Placebo
A2: KAI-1678
A3: Lidocaine
Arm Description
Placebo
Experimental
Lidocaine
Outcomes
Primary Outcome Measures
The effect of KAI-1678 on mean change from baseline in pain intensity at 6 hours (PID 6).
Measurements are made using a qualified pain scale and the change from basline is calculated at 6 hours.
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 response to treatment
The effect of KAI-1678 on symptoms associated with PHN assessed by the Neuropathic Pain Scale (NPS)
The number of adverse events as a measure of safety and tolerability of KAI-1678
Frequency of adverse events on each study treatment
Full Information
NCT ID
NCT01106716
First Posted
April 16, 2010
Last Updated
August 30, 2011
Sponsor
KAI Pharmaceuticals
Collaborators
Trident Clinical Research Pty Ltd
1. Study Identification
Unique Protocol Identification Number
NCT01106716
Brief Title
Safety and Efficacy Study of KAI-1678 to Treat Pain in Subjects With Postherpetic Neuralgia
Official Title
A Double-Blind, Randomized, Placebo- and Active-Comparator-Controlled, Single-Dose Study to Assess the Efficacy of KAI-1678 Administered by Subcutaneous Infusion in Subjects With Postherpetic Neuralgia
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
April 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 postherpetic neuralgia pain
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postherpetic Neuralgia
Keywords
Lidocaine, Lignocaine, Analgesics. Non-narcotic / therapeutic use, Neuralgia, Postherpetic, Pain, Pain measurement / drug effect, Pain postoperative / drug therapy, PHN
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
23 (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
Arm Title
A3: Lidocaine
Arm Type
Active Comparator
Arm Description
Lidocaine
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
Intervention Type
Drug
Intervention Name(s)
Lidocaine
Intervention Description
Lidocaine
Primary Outcome Measure Information:
Title
The effect of KAI-1678 on mean change from baseline in pain intensity at 6 hours (PID 6).
Description
Measurements are made using a qualified pain scale and the change from basline is calculated at 6 hours.
Time Frame
Day 1
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
Day 1
Title
The effect of KAI-1678 on patient global response to treatment
Time Frame
Day 1
Title
The effect of KAI-1678 on symptoms associated with PHN assessed by the Neuropathic Pain Scale (NPS)
Time Frame
Day 1
Title
The number of adverse events as a measure of safety and tolerability of KAI-1678
Description
Frequency of adverse events on each study treatment
Time Frame
Two weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
diagnosis of PHN with pain for at least 3 months after segmental herpes zoster eruption
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:
diagnosis of PHN with pain for at least 3 months after segmental herpes zoster eruption
pain score at least 4 on 11-point numerical rating scale (0-10)
stable doses of analgesic medications for at least 1 month"
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 Postherpetic Neuralgia
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